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Health Care Utilization Among Women Who Have Undergone Breast Implant Surgery

Report availablein alternate formats

British ColumbiaCentre of Excellencefor Women’s Health

Vancouver, BCCANADA

hospitalization

com

plic

atio

ns

breast implants

informed decisions

saline

silicone

By Aleina Tweed

WE’RE WOMEN TOO. IDENTIFYING BARRIERS TO GYNECOLOGIC AND BREAST HEALTH CARE FOR WOMEN WITH DISABILITIES �

Women’s Health Reports

Copyright © 2003 by BritishColumbia Centre of Excellencefor Women’s Health

All rights reserved. No part ofthis report may be reproducedby any means without the writtenpermission of of the publisher,except by a reviewer, who mayuse brief excerpts in a review.

ISSN 1481-7268ISBN 1-894356-28-4

Executive Editor Lorraine Greaves

Managing Editor Ann Pederson

Editors Janet MoneyLeslie Grant Timmins

Graphic Designand Illustration Jennifer Byun

Cover Design Working Design

Photo Credit Health Canada websiteand Media photo Gallery, http://www.hc-sc.gc.ca. © Reproduced with the permissionof the Minister of Public Works and Govern-ment Services Canada, 2003.

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E311 - 4500 Oak Street

Vancouver, British Columbia

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British ColumbiaCentre of Excellencefor Women’s Health

Centre d’excellence de laColumbie-Britanniquepour la santé des femmes

Canadian Cataloguingin Publication Data

Tweed, Aleina, 1974-

Health care utilization among women whohave undergone breast implant surgery

Includes bibliographical references.ISBN 1-894356-28-4

1. Medical care--Utilization--Canada. 2.Breast implants--Complications--Economicaspects--Canada. I. BC Centre of Excel-lence for Women’s Health. II. Title. III.Series: Women’s health reports (Vancouver,B.C.).

RD539.8.T83 2003362.1’9699449C2003-910426-5

� BRITISH COLUMBIA CENTRE OF EXCELLENCE FOR WOMEN’S HEALTH

Contents

Acknowledgements ..............................................................1I Executive Summary ...........................................................2II Introduction .........................................................................4

A. Purpose ...............................................................5B. Research Objectives ........................... ...............7C. Report Organization ............................................7

III Background .........................................................................8A. The Health Outcomes of Breast Implants ...........8B. Policy Issues in Canada and in British ................Columbia ..............................................................11

IV Methods .............................................................................13A. Study Design .....................................................13B. Study Group ...............................................13C. Comparison Group .......................................14D. Data Preparation ...............................................15E. Summary Descriptive Statistics ........................16F. Tests for Normality ............................................16

V Challenges and Limitations .............................................17VI Results ...............................................................................21

A. Overview ...........................................................21B. Descriptive Statistics: Demographic..................Descriptions ..........................................................21C. Descriptive Statistics: Implant Information ........23D. Descriptive Statistics: Outcome Variables ........25E. Other Variables and Confounders ....................34

VI Discussion .........................................................................36A. Overview ...........................................................36B. External Validity ................................................37C. Internal Validity .................................................38D. Health Trends ...................................................38E. Future Research Directions ..............................39

VIII Conclusion ........................................................................40References and Bibliography ..............................................41Appendix 1: Public Service Announcement .......................51Appendix 2: Informed Consent Letter and Form .................52


Appendix 3: Health Practices Questionnaire ......................57Appendix 4: B.C. MSP Subsidy Codes and StatisticsCanada Low-Income Cut-Offs ............................................64

Advisory Committee ............................................................66

List of TablesTable 1: Demographic Information (from questionnaires),Study group (n=92) .............................................................22Table 2: Socio-economic level, Study group andComparison group ..............................................................23Table 3: Implant-related surgeries subsequent toinitial implantation, Study group ..........................................25Table 4: Length of implantation, Study group (n=92) ..........25Table 5: Doctor visits, hospitalizations and specialistitems, Study group versus Comparison group ...............29Table 6: Specialists, Study group and Comparisongroup (MSP fee items) ........................................................30Table 7: Service provided in hospital, Study group andComparison group ..............................................................31Table 8: Physician most responsible (service) inhospital, Study group and Comparison group.................32Table 9: Level of care during hospital visits, Study groupand Comparison group .......................................................33Table 10: Length of stay in hospital, Study group versusComparison group 1991/92 to 1998/99 ..............................33Table 11: Hospital days in specific units, Study groupversus Comparison group ...................................................34

List of FiguresFigure 1: Reasons for choosing breast implantation,Study group (n=92) .............................................................24Figure 2: Hospital admissions, Comparison groupversus study group .........................................................27

�HEALTH CARE UTLIZATION AMONG WOMEN WHO HAVE UNDERGONE BREAST IMPLANT SURGERY

Acknowledgements

Thank you to:

Hamish Tweed, without whose support I would never havemade it.Penny Ballem for her insights and encouragement.Kim McGrail, whose patience and advice were unending.Ann Pederson for all her work and for her friendship.The women who agreed to participate, despite their misgivings.And, of course, my parents, who have given me everything.

I’d also like to thank the British Columbia Centre of Excellencefor Women’s Health, the B.C. Breast Implant Centre of BCWomen’s Hospital and Health Centre, the B.C. HealthResearch Foundation and the Canadian Health ServicesResearch Foundation.


IExecutive Summary

The health consequences of breast implant surgery range fromthe well-established local complications to the verycontroversial systemic complications. Complications often leadto additional surgeries. Although most women receive implantsthrough privately-funded health care, when they experiencecomplications they enter the public health care system. Thisresearch study tests the hypothesis that receiving breastimplants results in increased use of the public health system.Rather than investigating health outcomes, it focuses on theissue of health care utilization.

Data were collected for a study cohort of 147 women who haveundergone breast implant surgery and a non-implantcomparison group of 583 women matched by birth cohort andgeographic region. The data were extracted from the B.C.linked datasets. Outcome variables such as doctor’s visits,specialist visits, number of hospitalizations, level of care inhospital and days of care in hospital were examined over the11-year period from 1988/89 to 1998/99. Wilcoxon rank sumtests, chi-square tests and odds ratios were performed toanalyze these data.

Data were also collected from questionnaires completed by thewomen in the study group. These questionnaires collectedadditional implant factors (e.g., type of implant, length of timeimplant was in place) and lifestyle information (e.g., smoking,alcohol use, exercise, marital status, number of children).

Statistical analyses of the linked datasets showed that womenwho have or have had breast implants did experience morehospitalizations and did visit doctors and specialistssignificantly more than women who had not undergoneimplantation surgery. Women with implants were more likely tobe admitted to hospital (OR = 4.26, 95% CI = 2.58, 7.02). Theywere more likely to be admitted electively (OR = 1.90, 95% CI =

HEALTH CARE UTLIZATION AMONG WOMEN WHO HAVE UNDERGONE BREAST IMPLANT SURGERY �

1.50, 2.39) and less likely to be admittedas an urgent case (OR = 0.60, 95% CI =0.46, 0.78) or emergency case (OR =0.53, 95% CI = 0.35, 0.79).

The data showed that, despite somelimited relationships, neither lifestylefactors (e.g., education level, maritalstatus) nor implant factors (e.g., type ofimplant, length of time implant was inplace) accounted for the increasedhealth care utilization. However, thelonger implants had been in place, thefewer hospitalizations womenunderwent. This indicates a greaterneed for hospital care in the early yearsof implantation, care likely associatedwith local breast-implant complications.

Breast implant surgery does result inincreased use of the public health caresystem. Further investigation is neededto determine the causal mechanism.


IIIntroduction

For decades, women who have undergone breast implantsurgery have reported high implant failure rates and general,unidentifiable illness. In 1992, silicone gel-filled implants weresubject to government moratoriums in the United States and inCanada, until such time as their safety could be assured. In theyears that have followed, researchers have tried to findanswers. In the meantime, breast implantation continues tobecome more and more popular, with saline-filled implantstaking the place of their silicone predecessors.

In Canada an estimated 80% of breast implantation surgeriesare performed as cosmetic augmentation. Such surgery is notconsidered “essential” and is therefore paid for privately ratherthen through public insurance. However, if there are healthconsequences to this surgery – ranging from the well-established local complications to the very controversialsystemic complications – these women enter the public healthcare system for their care.

Breast implant research is beset by challenges, not the least ofwhich is the lack of a central registry allowing health careprofessionals or researchers to track women who receivebreast implants or to do any follow-up. (A companion paper tothis one, Registering the Impact of Breast Implants, discussesthe need for such registries (Pederson & Tweed, 2003)).Another challenge is that no retrospective breast implantresearch study can create an unbiased study sample. It is alsodifficult for a prospective study to follow women for anadequate period of time.

This project, rather than investigating health outcomes, focuseson this issue of health care utilization. If women who haveundergone breast implant surgery use the public health systemmore than women who have not undergone this surgery, thenthere is reason not only to be concerned for the health of these


implanted women, but also to beconcerned about the financialconsequences borne by governmentand, ultimately, by the public.

A. Purpose

The research study, Health CareUtilization Among Women Who HaveUndergone Breast Implant Surgery, askswhether or not women who haveundergone breast implant surgery usethe public health care system more and/or differently than women who havenever had such surgery. It was initiatedout of the need to answer questionsabout breast implants for women, forhealth care practitioners and for policy-makers. Although many researchershave tried to investigate links betweenbreast implants and health outcomes,there are challenges that make it nearlyimpossible to come up with conclusiveresults. However, there does seem to belittle doubt that at least some womenreact badly to breast implants (Segal,1997, p. 1; UK Independent ReviewGroup, 1998, p. 17).

We know that a very high number ofwomen have been affected by breastimplant-related complications (Segal,1997, p. 2; Powell & Leiss, 1997, p.107). A Mayo Clinic study in the UnitedStates, for example, found that 25% ofwomen with breast implants suffered

local complications requiring additionalsurgery within five years (Gabriel et al.,1997, p. 677). With regard toautoimmune disorders, in 1992 theCanadian Independent AdvisoryCommittee on Silicone Gel-FilledImplants stated that, “[s]omereassurance can be derived from thefacts that after three decades of use,there is no evidence of devastatinglyharmful effects on the majority of usersand that there is an absence ofevidence to support a causalassociation linking [silicone gel-filledimplants] to autoimmune disorders. Onthe other hand, since absence ofevidence does not prove anything, moreresearch should be carried out toascertain the risks associated withimplant use” (Baines et al., 1992, p. 6).

Although most of the many studiesinvestigating breast implantation andclassic autoimmune and connectivetissue diseases have found noassociation, these studies are limited byinadequate sample size, inadequatefollow-up, or poorly defined diseasecriteria (this is also true of those – fewerin number – that have shown anassociation) (Silverman et al., 1996, p.750). Several studies, as well asreviews conducted in the United Statesand in the United Kingdom, havesuggested no greatly increased risk ofspecific autoimmune or connective

We know that a very high number of women have been

affected by breast implant-related complications.


tissue diseases among women whohave undergone breast implant surgery(UK Independent Review Group, 1998,p. 26). However, these studies aregenerally too small to detect thepossibility of a slightly increased risk.The studies have only looked for thesymptoms of known autoimmunediseases, instead of the cluster ofsymptoms experienced by some womenwith breast implants (Mentor, n.d., p. 9-10). Often these studies are looking andtesting for known, defined diseasesinstead of a possibly new, undefinedillness. Because implant removal oftenresults in a reversal of symptoms, acausal link between the implants andthese symptoms is suggested (Sarweret al., 2000, p. 846).

Atypical connective tissue diseaseshave not been addressed specifically bymost studies. Those studies that haveattempted to do so were inconclusivedue to design flaws (Silverman et al.,1996, p. 750). The conclusion,therefore, is that there is still not enoughevidence to discount some causalrelationship between breast implantsand systemic illness (Baines et al.,1992, p. 32-33).

Health Care Utilization Among WomenWho Have Undergone Breast ImplantSurgery is beset by some of the samechallenges and limitations as otherstudies. However, it takes a novelapproach and therefore sheds somelight in new areas. Rather thanexamining health outcomes directly, itlooks at the connection between breastimplants and health care use. Althoughthis precludes answering questionsabout health or illness subsequent tobreast implantation or about causation,it does give some indication of potentialhealth trends among women whoundergo breast implant surgery, andidentifies areas for future research. Italso gives Canadian policy-makersinformation to help them betterunderstand the implications of thisprocedure and with which they can basefuture investigation, research and policydecisions.

This research will provide insights intothe continuing health of women whoundergo breast implant surgery. It willprovide insights into the publicly-borneconsequences of a private (andprivately-funded) surgery. And it adds tothe body of knowledge about breast

This study will provide insights into the publicly-borne

consequences of a private (and privately-funded)

surgery. And it will empower women to make informed

decisions about implantation.


implants, empowering women to makeinformed decisions about implantation.

B. Research Objectives

The primary research objective is toexamine health care utilizationsubsequent to breast implantation. Thisexamination will help determinewhether or not breast implantationaffects women’s use of the publichealth care system.

As well as providing an answer to theprimary research question above, thisproject:

• comments on the policyimplications of this utilization;

• adds to the body of knowledgeabout breast implants,empowering women to makeinformed decisions about breastimplantation and explantation(removal); and

• seeks to improve women’shealth status and ability toaccess sensitive health care byfurthering the knowledge andunderstanding of breast implantissues with health carepractitioners.

C. Report Organization

Following this Introduction, Section IIIprovides background information aboutsome of the health issues associated

with breast implants. Section IVdescribes the methodology of thisproject, including details of the studydesign, study and comparison cohortdefinitions, and data collection andanalysis issues. Section V presentssome of the challenges and limitationsfaced not only by this study but also byall research examining breast implant-related issues. Section VI presents theresults and Section VII provides somediscussion of those results anddirections for future research.Conclusions are presented in SectionVIII.


IIIBackground

A. The Health Outcomes of Breast Implants

In Canada, thousands of women have chosen breast implantsurgery, including an estimated 25,000 or more in BritishColumbia (Breast Implant Centre, Summer 1999, p. 1). As in allof North America, most (approximately 80%) of these surgeriesare for breast augmentation. The other 20% are forreconstruction after cancer or prophylactic mastectomy, or tocorrect under- or non-developed breasts (Segal, 1992, p. 1;Baines et al., 1992, p. 12). Many women who choose breastimplantation are very happy with the results of their surgery.They report psychological and emotional benefit from their newbody image (Bondurant et al., 2000, p. 28). However, manywomen report side-effects and feel that their short-term andlong-term health have been compromised.

There were 103,343 adverse reaction reports associated withsilicone breast implants and 23,454 reports involving salineimplants received by the U.S. Food and Drug Administrationbetween January 1, 1985 and September 17, 1996 (Segal,1997, p. 2; Powell & Leiss, 1997, p. 107). (Because the figuresfor the reports involving saline implants come from all FDAdatabases, there may be a few duplicate reports.)

There are three major groups of complications associated withbreast implants. These are local complications, systemiccomplications and psychological complications. Breast implantsurgery also carries the same risks associated with anysurgical implantation of a medical device.

1. Surgical complications

Any surgery – and breast implantation is no different – involvesrisks, such as possible complications of general anesthesia,infection, haematoma, hemorrhage, thrombosis, skin necrosis,

HEALTH CARE UTLIZATION AMONG WOMEN WHO HAVE UNDERGONE BREAST IMPLANT SURGERY

delayed wound healing, and additionalsurgeries (Health Protection Branch,1998, p. 2; Mentor, n.d., p. 8-9;Bondurant et al., 2000, p. 114; Sarwer etal., 2000, p. 847; Baines et al., 1992, p.22; Segal, 1997, p. 5).

A woman who receives breast implant(s)will likely require additional surgery orsurgeries related to her implant(s) overher lifetime. These procedures mayinclude treatment of capsularcontracture, correction of the implant’ssize or position, infection control as theresult of other local or systemiccomplications, or to prevent or treatleakage, rupture or other healthproblems (Baines et al., 1992, p. 22;Sarwer et al., 2000, p. 847; Bondurant etal., 2000, p. 119).

2. Local complications

Local complications can range from verymild to very severe, and they affect alarge percentage of women whoundergo breast implant surgery (Gabrielet al., 1997, p. 677). Capsularcontracture is one of the most significantcomplications. Contraction of the wall ofscar tissue surrounding the breastimplant may cause hardness of the

breast, discomfort and even severe pain(Mentor, n.d., p. 8). According to HealthCanada, capsular contracture occurs,usually within two years of surgery, inapproximately 25% of women whoundergo breast implant surgery (HealthProtection Branch, 1998, p. 2). Otherresearchers suggest the percentage isas high as 70%, and some estimate that100% of women with breast implants willdevelop capsular contracture to somedegree over the life of the implant(Sarwer et al., 2000, p. 847).

Implant deflation and rupture caused bynormal deterioration over time, breasttrauma or undetected damage or shellweakness in the implant are significantcomplications; one study found that70% of removed implants 11 to 15 yearsold were ruptured or leaking (Sarwer etal., 2000, p. 846). In a U.S. governmentstudy, two-thirds of 344 implantedwomen examined with MRI had rupturedimplants (American BroadcastCorporation, 18 May 2000). Deflation,leakage and rupture can result in thefilling of the breast implant being spreadthrough the body. The salt-watersolution contained within saline-filledimplants should be harmless. However,partly because of the semi-porous

According to Health Canada, capsular contracture

occurs, usually within two years of surgery, in

approximately 25% of women who undergo breast

implant surgery.


nature of breast implant shells andpartly because of faulty valves anddifficulties inherent in the sterilization ofbreast implant materials, it has beensuggested that the saline filler does notremain sterile. In one study, mostexplanted saline-filled breast implants,regardless of their age, had microbialgrowth in the implant and in the capsulesurrounding the implant. If the filler wasso contaminated, it would no longer beconsidered harmless upon deflation orrupture (Blais, 1998, p. 3-4; Mentor,n.d., p. 9).

Other complications include change inshape or volume of the breast; changein breast sensation; calcium deposits;mammographic interference, andbreast/chest discomfort or pain andnipple discharge (Segal, 1997, p. 5;Mentor, n.d., p. 7-9; Health ProtectionBranch, 1998, p. 2-3; Sarwer et al.,2000, p. 847; Baines et al., 1992, p. 19-22; Blais, 1998, p. 5).

3. Systemic complications

Systemic complications appear mostfrequently several years after breastimplantation. These complications tendto present as a cluster of symptoms,including those associated withautoimmune diseases, connective tissuediseases, “human adjuvant disease”and/or fibrositis/fibromyalgia-likedisorders. (The classic autoimmune andconnective tissue diseases thought tobe associated with silicone implants arescleroderma, systemic lupus

erythematosus, mixed connective tissuedisease, rheumatoid arthritis andSjogren-Larsson syndrome (Sarwer etal., 2000, p. 846).) Women with breastimplants have also reported granulomasand lymph node involvement, chronicflu, respiratory problems and infections(Sarwer et al., 2000, p. 846; Mentor,n.d., p. 9-10; Baines et al., 1992, p. 23-24; Segal, 1997, p. 5). The cluster ofsymptoms reported by these womenoften includes those present in morethan one such disease. Cancer alsoremains a concern – albeit a smallerone – associated with breast implants.

The link between breast implants andsystemic complications is still not clearlyunderstood. An association has beensuggested by anecdotal evidence, casereports and some scientific studies(Brautbar & Campbell, 1995; Baines etal., 1992); however epidemiologicresearch has not shown a significantincreased risk (Baines et al. 1992, p. 29-31; Segal 1997, p. 2).

4. Psychological complications

Unfortunately, studies of thepsychological consequences of breastaugmentation have been largelyanecdotal, consisting primarily ofsurgeons’ reports of their patients’satisfaction. These reports suggest thattypically 70% or more of patients reportsatisfaction with their surgical outcome(Sarwer et al., 2000, p. 851). Clearly,such investigations have seriousproblems. Firstly, how many patients will

HEALTH CARE UTLIZATION AMONG WOMEN WHO HAVE UNDERGONE BREAST IMPLANT SURGERY ��

admit, face-to-face with their surgeon,that they are not satisfied with theresults of their surgery? Secondly, howmany surgeons will admit, face-to-facewith their colleagues, that their patientsare not satisfied (Sarwer et al., 2000, p.851)?

There are many studies that suggestcosmetic surgery in general leads toimmediate post-operative improvementsin body image, quality of life, anddepressive symptoms. Other studies,however, have found that women whoundergo removal of breast implants(explantation) report higher levels ofbreast anxiety, upper torsodissatisfaction and depression bothbefore and after implant removal,compared to surgical and non-surgicalcontrols (Sarwer et al., 2000, p. 851).These findings suggest that breastimplant surgery leads to poorerpsychological well-being, rather thanbetter, for many women.

B. Policy Issues in Canada and inBritish Columbia

In Canada the only breast implants nowwidely available are saline-filledimplants (a silicone bag filled with saltwater). These implants, however, havenot been reviewed by Health Canada.

The Medical Devices Regulations wereintroduced in Canada in 1975. Theserequired notification of devices within 10days of being put on the market, butinvolved no evaluation. These

regulations were amended in 1977 sothat evidence of safety andeffectiveness was required beforemarketing. The list of devices coveredby this amendment did not, however,include breast implants. In October1982, a further change to theregulations was implemented, whichextended the pre-marketing review to alldevices, including breast implants,designed to be implanted in tissues orbodies for more than 30 days, thereforeincluding breast implants (Baines et al.,1992, p. 9).

The 1982 amendment required allimplantable devices to go through a pre-market evaluation of safety andeffectiveness data in order to obtain aNotice of Compliance and be allowed forsale in Canada (Health ProtectionBranch, 1998, p. 1). This evaluationincluded a review of animal and humantest results and manufacturing datasupplied by the manufacturer, byscientists at Health and WelfareCanada’s Bureau of Radiation andMedical Devices (Regush, 1993, p. 38).However, the review was required onlyfor devices introduced after the date theamendment became effective. Becausemost saline-filled implants wereavailable for sale before this date, theywere exempted from the pre-marketreview (Health Protection Branch, 1998,p. 1).

Currently, despite the moratorium onsilicone gel-filled breast implants, HealthCanada has begun allowing their use in

�� BRITISH COLUMBIA CENTRE OF EXCELLENCE FOR WOMEN’S HEALTH

certain circumstances. There aresuggestions that their popularity is againgrowing (Kirkey, 16 June 2001, 16A).Even as these silicone gel-filled implantsare being reintroduced, there has stillbeen little evaluation of the effects of thesaline-filled implants that are currentlywidely available. This represents a gapin public policy and should be addressedby Health Canada.

��HEALTH CARE UTLIZATION AMONG WOMEN WHO HAVE UNDERGONE BREAST IMPLANT SURGERY

IVMethods

A. Study Design

This study is a retrospective cohort study. The data used forthis project are health care utilization data collected from theBritish Columbia linked datasets by the Centre for HealthServices and Policy Research (CHSPR) at the University ofBritish Columbia (UBC), with permission from the B.C. Ministryof Health. Coded Personal Health Numbers (PHNs) were usedto collect the data, which include Medical Services Planrecords, Hospitalization records, Mental Health Servicesrecords and Long Term Care records.

Data were provided for two groups of women:

• A study group of 147 women (study group) who hadundergone breast implant surgery; and

• An anonymous comparison group identified by CHSPRof 583 women matched to the study group by birthcohort and geographic region.

Data from 11 years – 1988/89 to 1998/99 – were used.Although were provided for the preceding three years (1985/86to 1987/88), they were excluded because of data coding issuesthat made certain analyses impossible. Also, data from theLong Term Care and Mental Health databases were not usedin analyses. The number of cases in those datasets was sosmall as to render analyses invalid and unreliable, andtherefore inappropriate.

B. Study Group

The study group was comprised of women who self-identifiedas having had breast implant surgery. These women wererecruited by means of a letter sent to the women on the mailing


list of the B.C. Women’s Breast ImplantCentre at Children’s and Women’sHealth Centre of B.C. and by way ofpublic service announcements incommunity newspapers (see Appendix1).

Women who were interested inparticipating contacted a dedicatedtelephone line and were then sent aninformed consent letter and form (seeAppendix 2). This informed consentdocument described the project andasked for participation, personal healthnumbers (PHNs) and permission to usePHNs to access health records.Confidentiality was emphasized giventhe sensitive and personal nature of thissurgery.

Consent forms were returned by 153women, indicating their willingness toparticipate. Data from the B.C. linkeddatasets were collected for 147 of thesewomen. The remaining six were notincluded for logistical reasons includinglack of a personal health number,incorrect personal health number andincorrectly completed informed consentforms.

All 153 women were sent a survey (seeAppendix 3) to be completed andreturned in the addressed and stampedenvelope provided. Thesequestionnaires collected demographicinformation such as ethnicity, maritalstatus and dependents; implantinformation such as year of implantation,type of implant and repeat surgeries;

and lifestyle information such assmoking, alcohol consumption andexercise. It also asked about the use ofalternative health care services and out-of-country health services. Ninety-twowomen (63%) returned completedquestionnaires. (Of the questionnairesthat were not returned, 15 women hadmoved without a forwarding addressand two women had passed away.)

C. Comparison Group

The comparison group included womenliving in British Columbia matched towomen in the study group by five-yearbirth cohorts and geographic region(census tract in most cases, postal codein the very few cases where censustract did not produce adequatematching), in a 4:1 ratio.

These women were selected randomlyfrom the B.C. linked datasets byCHSPR. Women who appeared to havehad a breast implant were excluded.These women were identified based onthe presence of any of the followinghospital procedure codes in Section XV(97):

• 9721: (Unilateral) subcutaneousmastectomy with implantation ofprosthesis;

• 9723: Bilateral subcutaneousmastectomy with implantation ofprosthesis;

• 9743: Unilateral augmentationmammoplasty by implant or graft;

• 9744: (Bilateral) augmentation


mammoplasty by implant or graft;• 9793: Revision of implant

(prosthesis);• 9794: Removal of implant;• 9795: Insertion of breast tissue

expander(s);• 9796: Removal of breast tissue

expander(s).

Five women in the comparison groupwere excluded from analyses becausethey had died during the course of thestudy years.

D. Data Preparation

The data were reorganized into masterfiles and were examined for missing orunusual values. Based on this, specificdata fields were chosen for inclusion inthe analysis.

The key outcome variables werenumber of doctor’s visits (MSP) and thenumber of hospitalizations. These werecalculated by counting unique dates ofservice (rather than fee items, for whichthere may be more than one per visit).

Other outcome variables wereexamined:

• Specialty code;

• Total hospital days of care;

• Level of care;

• Admission category;

• Patient service code;

• Physician most responsible –service;

• Physiotherapy and occupationaltherapy; and

• General feelings of health withinthe study group.

Independent factors included in thestatistical analyses are:

• Socio-economic status based onMSP subsidy code. Thesesubsidy codes were entereduniversally only after September10, 1993, so only codes after thatdate contributed to the calculationof socio-economic status. Thewomen were categorized intothree socio-economic levels,based on the Statistics CanadaLow-Income Cut Offs for theyears 1993 to 1999 (seeAppendix D). These levels are:(1) annual net income above$19,000; (2) annual net incomebetween $15,000 and $19,000;and (3) annual net income below$15,000. As income changesyear to year, the level assigned isbased on the most common levelover the six years 1993/94 to1998/99. It should be noted thatthese levels serve mainly toseparate the very poor, the poorand the non-poor, as a “high”annual net income of $19,000 isby no means living in luxury, andthere are no data available onincome ranges above that level;

• Implant information from


completed questionnairesincluding type of breast implantand length of implantation; and

• Lifestyle factors from completedquestionnaires such as smoking,alcoholic drinks consumed perweek, amount of exercise,number of children, highest levelof education achieved and maritalstatus.

E. Summary Descriptive Statistics

Statistical analyses were performed toidentify any differences or lack thereof inpublic health care utilization patternsbetween women who have had breastimplants and women who have not. Thestatistical analyses examined and,where appropriate, controlled forvariables such as socio-economicstatus, lifestyle factors and breastimplant information.

All summary descriptive statistics andstatistical analyses were done usingSPSS Version 10.0.7.

The summary descriptive statisticsinclude frequencies, proportions, meansand standard deviations fordemographic data, for implant data andfor outcome variables.

The statistical tests performed included:

• Wilcoxon rank sum tests toidentify significant differences inhealth care utilization betweenstudy and comparison group

women for continuous variables;

• Pearson’s chi-square tests toidentify significant differences inhealth care utilization betweenstudy and comparison groupwomen for categorical variables;

• Tests for normality of outcomevariables; and

• Odds ratios and confidenceintervals to examine relative risk.

F. Tests for Normality

Skewness, kurtosis, Kolmogorov-Smirnov tests, histograms and normalprobability plots all served to confirmthat the outcome variables were notnormally distributed.

Attempts at transformations, includingnatural logarithms, square roots andreciprocals all failed to produce anormally distributed outcome variable.Non-parametric tests were thereforeused for analysis.


VChallenges and Limitations

There were a number of challenges and limitations that aroseduring the course of this research. Some are endemic to allbreast implant research, while others are specific to thisproject.

The most significant challenge is sample bias, which iscurrently unavoidable in most or all breast implant research.Breast implant surgery is most often paid for privately andperformed in plastic surgeons’ offices. As a result, individualswho choose this surgery are most often invisible in publichealth records. Moreover, there is no registry or database thattracks breast implantation at any level, making it impossible toidentify those who have chosen this surgery. All retrospectivebreast implant research therefore relies on those who haveundergone this surgery identifying themselves and agreeing toparticipate in research, rather than having the option ofidentifying a random study sample.

Some research teams have tried to overcome this problem bycreating study groups made up of entire populations of womenwho have received breast implants, drawn from plasticsurgeons’ files. Although this is certainly an improvement, ittakes a great deal of time, effort and travel, and thus a greatdeal of money. It also relies on plastic surgeons’ cooperationand, if long-term effects are to be examined, presumes thatthose surgeons keep their records for a good deal longer thanis required by law, as most systemic complaints arise only afterseven to ten years of implantation (Breast Implant Centre,1999).

The inability to create a random study group limits this projectas well. It introduces the potential of significant sample bias, aswomen who are unhappy with their breast implants or whohave experienced negative health outcomes are likely to havegreater motivation to participate in research. On the other hand,


it is also possible that those who arevery pleased with their breast implantsare more motivated to participate inresearch as they want to put to rest thepublic feelings that they endangeredtheir health or made bad decisionsbased on vanity.

Either way, this potential for sample biaslimits the conclusions that can be drawnfrom this study. The results cannot withcertainty be generalized to the entirepopulation of women with breastimplants. However, they are still veryuseful in that they can identify trends forthe study population, and indicate if andwhere further study is warranted.

Other challenges and limitations of thisresearch include:

o The inability to truly excludewomen who have had breastimplants from the control group. Itis possible that some women inthese groups did undergo breastimplant surgery, but accessed itprivately, making them invisiblefor these research purposes.However, given the relativelylarge size of the cohorts in thisstudy and the small estimatedpercentage of B.C. women whohave breast implants, thepossible inclusion of somewomen who have had breastimplants will not skew the results.

o The imperfection of any measureof socio-economic status short of

asking each participant aboutincome. This was not possible, aswomen in the control group werenot identified at any time. MSPcode was therefore used as aproxy for socio-economic status.Although this does not providespecific income-relatedinformation, it does serve as anaccurate measure to separate thepoor from the non-poor.

o The inability, due to time andfunding constraints, to test thesurvey instrument beforedistribution. This resulted in someproblems with the completedquestionnaires. The surveyinstrument was designed to besimple and as short as possibleto encourage high return rates.Although these rates were indeedhigh, the attempt at simplicity hurtthe quality of the informationprovided. Many questions wereanswered incompletely and/orincorrectly, or lacked clarity anddetail. As a result, for example, itwas not possible to use thequestionnaires to compare pre-and post-implant or explanthealth care use, nor to comparethe effects of different types ofimplants or different lengths ofimplantation, except at the mostbasic level.

o The inappropriateness of makingany claims regarding the safetyor lack thereof of breast implants,


regardless of results. This projectexamined only health careservices and did not look athealth outcomes or causativerelationships between breastimplants and health. Therefore,although the data indicate thatthere are associations betweenbreast implants and increasedhealth care utilization, it is notappropriate to expand theseclaims to include safety issues.

o The inability, due to the lack ofimplant information in publichealth records, to create an“index date” (date ofimplantation), and thus moreaccurately assess whetherincreased health care utilizationoccurred after implantation.However, the completed surveysfrom 92 women with breastimplants identified the year ofinitial implantation. Threequarters of these womenreceived their implants before1990, meaning that they wereimplanted before (or very soonafter) the first year of health careutilization data used in thisproject (1988/89). Therefore, thisgap is not a serious issue thateither compromises the validity ofthis study or precludes drawingconclusions based on the trendsseen here.

There are also some possibleconfounders that were considered:

• Those living outside majorcentres may have limited accessto health care services. Thisshould not be a major issue inthis study, as most of the womenlive in major cities, and of thosewho do not, most live in smallcities rather than rural areas.Moreover, study group andcomparison group women werematched by geographic region,eliminating the possibility thatobserved differences were theresult of differences in healthcare accessibility due to place ofresidence.

• The presence of other implants,silicone or otherwise, couldconfuse the results. Of the 92women in the study group whocompleted questionnaires, onlytwo had implants other thanbreast implants. This very limitedpresence will not bias or skew theresults.

• Not all health service utilization isrecorded in public health caresystem data. Some women whohave had breast implants suggestthat they often face such barriersand discrimination in the publichealth care system that they turnto other types of health care.Over one-half (52.2%) of thewomen who completedquestionnaires reported havingaccessed at least one type ofalternative health care, and many


had used more than one. It ispossible – and has beensuggested that it is probable –that public health systemutilization rates are lower than“true” health services utilizationrates because of the use ofprivately accessed alternativehealth therapies. This, if true,biases the results of this studytowards the null hypothesis, andtherefore would only strengthenarguments of associationsbetween breast implants andincreased health care usage.


VIResults

A. Overview

What this research revealed was that there is, indeed, astatistically significant relationship (a p value less than or equalto 0.05, unless otherwise noted) between breast implantsurgery and health care utilization. Women who haveundergone breast implant surgery show statistically increaseduse of the public health care system over what we would deem“normal” use (defined as the use by women who have not hadbreast implant surgery).

Specifically and most importantly, women who have undergonebreast implant surgery:

• visited the doctor more often;

• visited more specialists more often; and

• were hospitalized more often.

Poisson regression could be performed to explore furtherpossible relationships between potential confounders orinteractions such as lifestyle factors or implant information.Such analyses were not performed in this study, due to thepoor quality of such data and the evidence that, in general,such interactions were not significant.

B. Descriptive Statistics: Demographic Descriptions

The study group of women who had undergone breast implantsurgery is a fairly homogenous group. According to thecompleted questionnaires, almost all are Caucasian and speakEnglish at home. They are a well-educated group, with almostall having at least a high school education, and the largestpercentage having a post-secondary degree. Most are married


or in common-law relationships andhave at least one child. Table 1 lays outthese descriptives.

The women range in age from 29-81years. The mean age is just over 54years, and most women fall in the 45-60year range. As each woman in the studygroup was matched by age as well asgeographic region, the age distributionsin the study and comparison groups arethe same.

Among those in the study group whocompleted questionnaires, most (55.4%)live in larger urban centres. The others

live in smaller cities outside the LowerMainland of B.C. (27.2%) or in ruralareas (17.4%). This distribution is thesame for the control group, given thatthey were matched by geographicregion.

Most of those in both cohorts are in ahigher socio-economic level. Theselevels serve mainly to separate the poorfrom the non-poor, as they do notprovide income information in theannual net income ranges above$19,000. Table 2 provides the socio-economic breakdown for these groupsof women.

Table 1: Demographic information (from questionnaires), Study group (n=92)

* In the case of information collected from the questionnaires, “missing” means either the question was not completed or it wascompleted incorrectly and cannot, therefore, be used.

)%(ycneuqerF )%(ycneuqerFyticinhtE emohtanekopsegaugnaL

naisacuaC )%8.79(09 hsilgnE )%5.39(68naisA )1.1(1 rehtO )1.1(1

*gnissiM )1.1(1 gnissiM )4.5(5sutatSlatiraM leveLnoitacudE

wal-nommoc/deirraM )%4.76(26 loohcshgihnahtsseL )%3.3(3decrovid/detarapeS )3.61(51 loohcshgiH )8.22(12

elgniS )5.6(6 yradnoces-tsopemoS )7.33(13dewodiW )7.8(8 eergedyradnoces-tsoP )0.83(53

gnissiM )1.1(1 gnissiM )2.2(2nerdlihCforebmuN

enoN )%0.21(112-1 )5.34(044-3 )1.93(63

eromro5 )4.5(5


Table 2: Socio-economic level, Study group and Comparison group

leveLcimonocE-oicoS )741=n(puorGydutS)%dilaV(ycneuqerF

)385=n(puorgnosirapmoC)%dilaV(ycneuqerF

000,91$revO )%3.08(811 )%4.37(824000,91$ot000,51$ )7.0(1 )5.1(9

000,51$rednU )0.91(82 )8.11(96**gnissiM )0.0(0 )2.31(77

** Data from the B.C. linked datasets is coded as “missing” if the data is missing entirely or is coded incorrectly.

C. Descriptive Statistics: ImplantInformation

The completed surveys providedlimited implant information includingreasons for implantation, type ofimplant and length of time since initialimplantation.

The reasons that these women chosebreast implant surgery vary. All centreon the desire to look “normal” and“feminine.” Consistent with the reportsof other studies (Segal, 1992, 1;Baines et al., 1992, 12), most of thewomen in this study group chosebreast implants for augmentation,while a smaller percentage chosebreast implants for reconstructionafter a mastectomy (see Figure 1).

Of the 92 women who returnedquestionnaires, almost half (n=40)had their initial breast implant surgeryin the 1980s. Twenty-seven percent ofthe women (n=25) received theirimplants in the 1970s and 25% (n=23)in the 1990s. Only four women hadreceived their breast implants earlier,

in the 1960s. Length of implantation byyear is provided in Table 4.

Almost two-thirds (60%) of these womenwere given silicone gel-filled breastimplants as their first set of breastimplants. One-quarter (26%) of thewomen were implanted with saline-filledbreast implants, and the rest receivedbi-lumen, triple-lumen, silicone gel-filledimplants with Dacron patches or Mêmeimplants. Some of the women (n=4) didnot know what kind of breast implantthey had. Many of the women (34%) didnot know who had manufactured theirfirst set of implants, but of those who didmost (75%) had Dow Corning implants.This is not surprising given that DowCorning was the largest breast implantmanufacturer until the 1992 moratorium.

As discussed above, breast implantationis rarely a one-time surgery. Additionalsurgeries are often required due tocomplications. Among the 92questionnaire respondents in this studygroup, over half (51%) of therespondents reported at least oneadditional breast implant-related surgery


subsequent to the initial implantation. Ofthose, half (49%) had had oneadditional surgery, 23% had had two,11% had had three, and 17% had hadfour or more additional surgeries (seeTable 3).

Some of these may have been implantreplacement surgeries, while many arenot. Three quarters (77%) of the womenhave not had to replace either of theirbreast implants. Of the others, two-

thirds replaced both their implants, whilethe remaining third replaced only one.And while half (52%) of these womenonly had to replace their implant(s)once, 29% replaced their implant(s)twice and 19% replaced their implant(s)three or four times.

For some of these women, thecomplications were enough to convincethem that they no longer wanted breastimplants. Thirty-seven of the women

Figure 1: Reasons for choosing breast implantation, Study group (n=92)*

*The category “Augmentation for non-development of one breast/both breasts” was meant to refer to a condition calledmicromastia where usually one breast, but sometimes both breasts, does not develop at all. This is different from feelingsof having small breasts. However, this distinction may not have been clear in the survey instrument and it is possible thatsome women checked this category when it would have been more appropriate for them to have checked “cosmeticaugmentation.”


who returned questionnaires (40%) hadhad their implants permanentlyexplanted. The rest (n=55), have not.

There was no explicit question on thesurvey instrument asking aboutpermanent explantation, only asking fora date of permanent explantation ifapplicable. As with other areas of thequestionnaire (discussed in Section V:Challenges and Limitations), there mayhave been some confusion here, and itis possible that women who have hadtheir implants taken out permanently didnot provide a date, in which case theycould not be identified as having hadpermanent explantation.

D. Descriptive Statistics: OutcomeVariables

Among those women who returnedcompleted questionnaires, most ratedtheir health as excellent (n=30) or good(n=35) compared to other women theirown age. The rest felt that their healthwas fair (n=12) or poor (n=13).

Despite these feelings of good health,fully half of these women had beendiagnosed with at least one chronicillness. Furthermore, one-third (n=33)felt that they had lost or quit their job orreduced their hours because of healthproblems, and more than half hadproblems doing housework orrecreational activities due to healthproblems. The majority reported that thehealth problems that affected their job ortheir housework occurred after they got

Table 3: Implant-related surgeriessubsequent to initial implantation,

Study group

Table 4: Length of implantation,Study group (n=92)

fohtgneLnoitatnalpmI

)%(ycneuqerF

sraey5-0 )%3.61(51

sraey01-6 )4.71(61

sraey51-11 )7.12(02

sraey02-61 )7.02(91

sraey52-12 )0.31(21

sraey03-62 )5.6(6

sraey04-03 )3.4(4

puorgydutS)29=n(

)%(ycneuqerFseiregruslanoitiddA

enoN )%9.84(54enO )0.52(32owT )0.21(11

eerhT )4.5(5eromroruoF )7.8(8

tnemecalpeRtnalpmIenoN )%2.77(17

tnalpmienO )6.7(7stnalpmihtoB )2.51(41

forebmuN)12=n(stnemecalpeR

enO )%4.25(11owT )6.82(6

ruoFroeerhT )0.91(4


their breast implants (88% and 78%,respectively).

The B.C. linked data providesquantitative, rather than qualitative data.These data show that the women in thestudy group were hospitalized moreoften and visited doctors in general andspecialists specifically significantly ( p<0.05, unless otherwise noted) more oftenthan did the women in the comparisongroup over the eleven-year study period.These women were also much morelikely to be hospitalized over this period(Odds Ratio = 4.26, 95% ConfidenceInterval = 2.58, 7.02). Theserelationships remained significant whenbroken down by year, as is illustrated inTable 5. (Hospitalizations were notsignificant in 2 of the 11 years,presumably aberrations.)

These same analyses were performedcomparing only those women in thestudy group who had self-identified ashaving chosen breast implant surgery forreasons other than reconstruction aftermastectomy for malignant disease to thecomparison cohort. The results of thesesub-analyses were the same as thosecomparing the entire study cohort to thecomparison cohort.

While 27.5% of the MSP fee items in thestudy cohort and 30.8% of items in thecomparison cohort were for generalpractitioners (a significant difference,p<0.001), the remainder was forspecialists. Table 6 shows the number ofitems in each specialty among women in

both the study group and comparisongroup. A Pearson chi-square testindicates that the proportions ofspecialists accessed between the twocohorts is not equal (p<0.001). In otherwords, having undergone breast implantsurgery did appear to affect specialistitems both in increased number and indifferent type.

Despite small apparent differences inthe percentages of fee items in eachgroup dedicated to each specialty, thesedifferences were frequently significant.The p-values in Table 6 identify thosespecialties where the differencebetween the two cohorts is significant,and in which specialties it is not.

There are also differences in terms ofhospital admissions. Women in both thestudy group and comparison group weremost likely to be admitted electively.However, women in the study groupwere almost twice as likely to beadmitted in this category (OR = 1.90,95% CI = 1.50, 2.39). In other admissioncategories, however, this trend isreversed. Women in the study groupwere 40% less likely than those in thecomparison group to be admitted in theurgent category (OR = 0.60, 95% CI =0.46, 0.78) and only half as likely to beadmitted as an emergency case (OR =0.53, 95% CI = 0.35, 0.79). Thisrelationship between cohort and hospitaladmissions is a significant one(Pearson’s chi-square test p<0.001).Figure 2 illustrates the differences inhospital admissions.


Comparison Group

Elective63%

Urgent26%

Emergency11%

Study Group

Elective77%

Urgent17%

Emergency6%

Figure 2: Hospital admissions, Comparison group versus Study group

Once admitted to hospital, the servicesprovided to the women in both groupswere the same in all but three areas. APearson chi-square test showed that theproportions of services accessed ineach group are not equal (p<0.001).The difference in services is primarily ingeneral surgery and plastic surgery –areas that we would expect to beassociated with local breast implant-related complications. Gastroenterology

and urology were other areas wherethere was a significant differencebetween cohorts. Table 7 provides thebreakdown of services provided for eachgroup.

As with services provided, women in thestudy group and comparison group hadthe same types of physiciansresponsible for their care in hospital. APearson’s chi-square analysis rejects anull hypothesis that these physicianproportions among the women in the

two groups are equal (p<0.001).However, Wilcoxon rank sum testsshowed that the only significantdifferences were for care by plasticsurgeons, general surgeons andgastroenterology specialists (see Table8).

There was no difference between thetwo groups in terms of their level of care

in hospital. As Table 9 shows, women inthe two cohorts were most oftenhospitalized at an acute level of care(55%) or for day surgery (44%). APearson chi-square test showed that wecould not reject the null hypothesis thatthe level of care proportions are equalbetween the two groups (p=0.68) andodds ratios supported the hypothesisthat neither group was more likely to berepresented in any level of care. Theexception is in extended care, wherewomen who have had breast implants


are more than five times more likely tobe. However, the numbers are verysmall, suggesting that this odds ratio ismisleading and should not beconsidered accurate.

The total number of days spent inhospital is only available for the eightyears 1991/92 to 1998/99. Over theseyears, the mean number of days of carein hospital was 2.2 in the study groupand 3.8 in the comparison group, whichis not a statistically significant difference.Because hospitalization trends andlength of hospital stays have changeddramatically over the last couple ofdecades, days of care were alsoanalyzed on a yearly basis. The meannumber of days of care was still slightlyhigher among the control group,although again the difference was notsignificant. (The difference in days ofcare was significant in 1997/98,presumably an aberration.) Table 10illustrates these relationships.

Length of stay was also measured bymore specific area: Intensive Care Unit(ICU) days, Continuing Care Unit (CCU)days, Rehabilitation Unit days,Discharge Planning Unit (DPU) days,Chronic Behaviour Disorder Unit daysand Acute Care days. As with overalllength of stay, all observed differenceswere not statistically significant (seeTable 11). Although not significant, thetrend was the same as with total days ofcare with women in the comparisongroup spending slightly more days ineach unit that women in the study group.However, the mean number of days is

very small so interpretations must becautious.

It is interesting to note that while womenwho had had breast implants wereadmitted to hospital more often (3.7visits per woman compared to 2.0 visitsper woman, respectively), women whohad not had implants seemed to staylonger. This again supports theassertion that local breast implant-related complications are contributing toan increased need for shorter-termhospital care such as plastic or generalday surgery.

Some women in both groups receivedphysiotherapy or occupational therapyencounters while in hospital. Women inthe study group underwent an averageof 0.27 physiotherapy encounters perwoman (n=147) compared to 0.21encounters per woman in thecomparison group (n=583). However,women in the study group were overallless likely to be provided withphysiotherapy services in hospital (OR =0.68, 95% CI = 0.47, 0.99).Occupational therapy was utilized evenless, with a mean of only 0.068encounters per woman in the studygroup and 0.055 encounters per womanin the comparison group. As withphysiotherapy encounters, women withbreast implants were less likely thanthose without to need occupationaltherapy (OR = 0.68, 95% CI = 0.33,1.39). The differences between the twogroups appear small, and indeed,neither difference was statisticallysignificant in a Wilcoxon rank sum test.


Table 5: Doctor visits, hospitalizations and specialist items,Study group versus Comparison group.

* SD = Standard deviation** P-values calculated using Wilcoxon rank sum tests.*** ns = not statistically significant at the p=<0.05 level.

)741=n(puorgydutS)*DS(naeM

)385=n(puorgnosirapmoC)DS(naeM

**eulav-p

stisiVPSM )65.901(8.551 )22.29(92.59 100.0<98/8891 )58.21(8.11 )25.9(18.7 200.009/9891 )11.21(45.01 )42.9(44.7 100.019/0991 )48.21(93.11 )28.01(09.7 100.0<29/1991 )69.41(25.31 )38.11(89.8 100.0<39/2991 )51.31(63.21 )24.01(09.7 100.0<49/3991 )28.81(08.61 )81.21(60.9 100.0<59/4991 )33.21(93.41 )89.31(38.9 100.0<69/5991 )11.41(07.61 )72.41(73.9 100.0<79/6991 )25.21(96.61 )39.11(49.8 100.0<89/7991 )35.21(76.61 )59.11(23.9 100.0<99/8991 )77.01(84.51 )84.11(98.8 100.0<

snoitazilatipsoH )75.3(96.3 )30.4(10.2 100.0<98/8891 )46.0(62.0 )54.0(51.0 ***sn09/9891 )36.0(92.0 )15.0(71.0 900.019/0991 )45.0(12.0 )75.0(91.0 sn29/1991 )15.0(22.0 )95.0(71.0 140.039/2991 )37.0(13.0 )67.0(81.0 500.049/3991 )47.0(33.0 )87.0(91.0 100.0<59/4991 )06.0(92.0 )59.0(32.0 500.069/5991 )99.0(35.0 )66.0(12.0 100.0<79/6991 )08.0(64.0 )36.0(61.0 100.0<89/7991 )79.0(14.0 )25.1(32.0 100.0<99/8991 )17.0(73.0 )85.0(61.0 100.0<

smetItsilaicepS )47.412(83.422 )56.341(88.721 100.0<98/8891 )45.22(76.51 )95.51(72.01 200.009/9891 )31.42(25.61 )72.91(78.11 600.019/0991 )21.71(20.21 )05.51(27.8 600.029/1991 )09.22(88.61 )54.12(28.21 100.0<39/2991 )89.12(21.51 )36.51(43.9 100.0<49/3991 )88.16(52.82 )63.32(86.21 100.0<59/4991 )28.03(39.22 )66.32(60.41 100.0<69/5991 )02.34(39.13 )06.92(47.51 100.0<79/6991 )82.92(53.72 )35.12(38.21 100.0<89/7991 )47.02(99.91 )82.41(47.9 100.0<99/8991 )34.61(17.71 )07.61(28.9 100.0<


*P-values calculated using Wilcoxon rank sum tests for each individual specialty.**The five most common specialists are the same in both cohorts, and are highlighted.***ns = not statistically significant at the p=<0.05 level.****n/a = not applicable, as there are no values in either cohort.

Table 6: Specialists, Study group and Comparison group (MSP fee items)

ytlaicepS puorgydutS)518,54=n(

)%(ycneuqerF

puorgnosirapmoC)371,801=n(

)%(ycneuqerF

*eulav-p

tsigoloisehtseanA )%3.3(6901 )2.2(5661 100.0<reciffOytlausaC )2.0(87 )3.0(902 710.0**rotcarporihC )7.41(9484 )2.61(01121 100.0<noegruSlatneD )0.0(0 )1.0<(9 ***sntsigolotamreD )0.1(813 )2.1(119 100.0<noegruSlareneG )6.1(145 )4.1(3601 100.0<

tsilaicepSenicideMlanretnI )5.4(0841 )9.4(1363 100.0<tsiparehTegassaM )6.8(5582 )6.6(4594 100.0<tsigoloiborciMlacideM )5.1(684 )1.1(348 100.0<

htaporutaN )4.1(074 )0.1(527 100.0<tsigolorueN )6.0(391 )5.0(933 100.0<

tsirtaihcysporueN )0.0(0 )1.0<(3 snnoegrusorueN )1.0(71 )1.0(36 sn

tsilaicepSenicideMraelcuN )6.0(802 )4.0(323 100.0<tsigoloceanyG/naicirtetsbO )9.1(216 )6.1(5811 100.0<

tsigolomlahthpO )7.1(055 )1.2(3951 100.0tsirtemotpO )5.1(805 )0.2(8541 100.0<noegruSlarO )1.0<(6 )1.0(15 sntsitnodohtrO )0.0(0 )0.0(0 ****a/n

tsilaicepScideapohtrO )0.0(0 )0.0(0 a/nnoegruScideapohtrO )4.0(441 )7.0(505 sn

htapoetsO )0.0(0 )1.0<(82 sntsigolognyralotO )9.0(782 )7.0(294 100.0<

tsigoloidraCcirtaideaP )0.0(0 )0.0(0 a/nnaicirtaideaP )2.0(26 )1.0(68 sntsigolohtaP )4.52(6048 )0.92(63612 100.0<

tsilaicepSenicideMlacisyhP )1.0(43 )2.0(721 sntsiparehtoisyhP )5.81(5216 )9.71(56331 100.0<

noegruScitsalP )2.2(827 )4.0(892 100.0<tsirtaidoP )0.1(933 )7.1(9521 sntsirtaihcysP )2.2(027 )5.1(6111 100.0<

tsilaicepShtlaeHcilbuP )0.0(0 )1.0<(4 sntsigoloidaR )1.5(6961 )5.5(9214 100.0<esruNlaicepS )0.0(0 )0.0(0 a/n

tsilaicepSralucsavoidraC&cicarohT )1.0(42 )2.0(631 sntsigolorU )5.0(251 )3.0(632 200.0

gnissiM )1.0(75 )1.0(79


ecivreS )245=n(puorgydutS)%(ycneuqerF

)9811=n(puorgnosirapmoC)%(ycneuqerF

*eulav-p

eraCfoleveLetanretlA )%0.0(0 )%1.0(1 **snygoloidraC )9.0(5 )4.3(14 sn

yregruSralucsavoidraC )2.0(1 )3.1(61 snecitcarPylimaF )0.0(0 )1.0(1 sn

***ygoloretneortsaG )6.6(63 )6.6(97 100.0enicideMlareneG )7.01(85 )0.61(091 snyregruSlareneG )0.62(141 )4.02(342 100.0<

ygoloceanyG )7.01(85 )1.31(651 snygolotameaH )0.0(0 )2.0(2 sn

ygolorhpeN )9.0(5 )4.0(5 snygolorueN )4.0(2 )5.0(6 sn

yregrusorueN )4.0(2 )8.0(01 sndetrobAscirtetsbO )8.1(01 )1.1(31 sn

mutrapetnAscirtetsbO )4.0(2 )1.1(31 snderevileDscirtetsbO )8.4(62 )0.7(38 snmutraptsoPscirtetsbO )0.0(0 )2.0(2 sn

ygolocnO )4.0(2 )5.0(6 snygolomlahthpO )1.1(6 )1.4(94 sn

yregruSlarO )0.0(0 )4.0(5 snyregruScideapohtrO )1.3(71 )9.5(07 sn

ygolognyralotO )3.1(7 )9.1(22 sneraCevitaillaP )0.0(0 )9.0(11 snyregruScitsalP )2.12(511 )1.2(52 100.0<

yrtaihcysP )5.1(8 )9.1(22 snlatipsoHeraCetucAnibaheR )6.0(3 )4.0(5 sn

ygoloripseR )2.0(1 )9.1(22 snygolotamuehR )0.0(0 )1.0(1 sn

yregruScicarohT )2.0(1 )3.0(3 snygolorU )9.5(23 )5.5(56 300.0gnissiM )7.0(4 )9.1(22

Table 7: Service provided in hospital, Study group and Comparison group

*P-values calculated using Wilcoxon rank sum tests for each individual service.**ns = not statistically significant at the p=<0.01 level.***The five most common specialists are almost the same in both cohorts, with the only difference being plastic surgeryand obstetrics delivered. All those falling in the top five of either cohort are highlighted.


ecivreS )245=n(puorgydutS)%(ycneuqerF


*eulav-p

tsigoloisehtseanA )%0.0(0 )%4.0(5 **sntsigoloidraC )6.0(3 )9.1(32 sn

noegruSralucsavoidraC )0.0(0 )4.0(5 sntsilaicepSeraClacitirC )4.0(2 )3.0(3 sn

tsitneD )0.0(0 )1.0(1 sntsigoloidaRcitsongaiD )2.0(1 )9.2(53 sn

msilobateMdnatsigolonircodnEtsilaicepS

)0.0(0 )3.0(3 sn

renoititcarPylimaF )7.01(85 )7.51(781 sn***tsigoloretneortsaG )9.5(23 )5.5(56 100.0<

renoititcarPlareneG )0.0(0 )3.0(3 snnoegruSlareneG )4.61(98 )0.31(551 100.0<

naicirtaireG )6.0(3 )0.0(0 sntsigolotameaH )0.0(0 )3.0(4 sn

tsilaicepSesaesiD.cefnI )0.0(0 )1.0(1 sntsinretnI )7.1(9 )6.2(13 sn

tsigolorhpeN )0.0(0 )2.0(2 sntsigolorueN )4.0(2 )4.0(5 snnoegrusorueN )6.0(3 )6.0(7 sn

tsigoloceanyG/naicirtetsbO )3.01(65 )8.21(251 sntsigolocnO )0.0(0 )2.0(2 sn

tsigolomlahthpO )5.1(8 )1.4(94 snnoegruSlarO )2.0(1 )2.0(2 sn

noegruScideapohtrO )1.3(71 )1.5(16 sntsigolognyralotO )5.1(8 )2.1(41 sn

tsirtaisyhP )0.0(0 )3.0(3 snnoegruScitsalP )0.22(911 )2.3(83 100.0<

tsirtaidoP )2.0(1 )0.0(0 sntsirtaihcysP )4.0(2 )5.1(81 sn

tsigolocnOnoitaidaR )0.0(0 )1.0(1 sntsigoloripseR )7.1(9 )2.2(62 sn

tsigolotamuehR )0.0(0 )2.0(2 snnoegruScicarohT )2.0(1 )4.0(5 sn

tsigolorU )3.6(43 )3.4(15 snnoegruSralucsaV )2.0(1 )3.0(4 sn

gnissiM )3.51(38 )0.91(622

Table 8: Physician most responsible (service) in hospital,Study group and Comparison group

*P-values calculated using Wilcoxon rank sum tests for each individual physician service area.**ns = not statistically significant at the p=<0.01 level.*** Physician areas where the observed relationship is statistically significant (p=<0.01) are highlighted.


*OR = Odds Ratio**DPU = Discharge Planning Unit***Odds Ratios could not be calculated for three of the levels of care because there were no values in these levels in the studygroup.

Table 9: Level of care during hospital visits, Study group and Comparison group

Table 10: Length of stay in hospital, Study group versus Comparison group1991/92 to 1998/99

* P-values calculated using Wilcoxon rank sum tests.** SD = Standard Deviation*** ns = not statistically significant at the p=<0.05 level.

eraCfoleveL )245=n(puorgydutS)%(ycneuqerF


*eulav-p

etucA )%9.45(792 )%6.45(946 )42.1,28.0(10.1yregruSyaD )3.44(042 )3.44(725 )32.1,418.0(00.1eraCdednetxE )9.0(5 )2.0(2 )75.82,70.1(35.5

RAEG/**UPD )0.0(0 )4.0(5 ***a/nnoitatilibaheR )0.0(0 )3.0(4 a/n

gnidloHCTL )0.0(0 )2.0(2 a/n

latipsoHlatoTeraCfosyaD

)741=n(puorgydutS )385=n(puorgnosirapmoC *eulav-p

stisivfo.oN )**DS(naeM stisivfo.oN )DS(naeM

sraeyllA 134 )30.4(2.2 098 )8.9(8.3 ***sn29/1991 43 )1.3(9.1 401 )5.6(5.3 sn39/2991 54 )7.2(8.1 401 )7.7(1.4 sn49/3991 05 )1.2(5.1 801 )6.31(4.4 sn59/4991 24 )9.2(1.2 331 )4.11(8.4 sn69/5991 87 )8.4(0.3 221 )7.9(3.4 sn79/6991 76 )5.4(0.2 59 )7.4(2.2 sn89/7991 16 )3.5(7.2 431 )4.8(1.3 510.099/8991 55 )1.4(9.1 39 )7.21(6.3 sn


*SD = Standard Deviation**ns = not statistically significant at the p=<0.05 level

E. Other Variables and Confounders

Age and geographic region were twopotential confounders that werecontrolled for during sample selection.Most other lifestyle and implant factorsdid not affect the number of MSP visits,specialist fee items or hospitalizationsamong the women with breast implantswho returned completed questionnaires.

• There was no associationbetween any of these outcomevariables and marital status,highest education level achieved,number of alcoholic drinks perweek or exercise.

• Number of children resulted in amarginally significant decrease inhospitalizations among those withno children compared to thosewith one and two children or three

and four children. Thisrelationship was not observed incomparing those with five ormore children to those with nochildren, or in other combinationsof these groups.

• Ethnicity and language could beconfounders. However, thisproject’s study sample is a veryhomogeneous group. The vastmajority (98%) of those whocompleted questionnairesconsider themselves Caucasianand speak English at home. Itwas therefore not possible toexamine differences due to thesefactors.

• At first, it appeared that saline-filled breast implants wereassociated with significantlyhigher numbers of

Table 11: Hospital days in specific units, Study group versus Comparison group

tinU )245=n(puorgydutS)*DS(syaD

)871=n(puorgnosirapmoC)DS(syaD

*eulav-p

UCI )160.0(400.0 )155.0(340.0 snUCC )680.0(700.0 )515.0(050.0 sn

noitatilibaheR )233.1(490.0 )360.2(031.0 snUPD )000.0(000.0 )72.1(260.0 sn

redrosiDruoivaheBcinorhC )000.0(000.0 )000.0(000.0 a/neraCetucA )520.4(791.2 )131.9(355.3 sn


hospitalizations than silicone gel-filled implants (mean of 4.50compared to 3.07; p=0.006).However, this was a result of thegreatly increased percentage ofsaline-filled breast implants thathad been implanted for five yearsor less (the time when many localcomplications are firstexperienced). Among the rest,there was no significantdifference between those withsaline-filled implants and thosewith silicone gel-filled breastimplants for any of the outcomevariables.

There were observed associations incertain areas:

• Having ever smoked was stronglyassociated with a significantincrease in all outcome areasamong women in the studygroup. Those who had eversmoked at all (n=50) experiencedan average of 4.12 hospital visits,compared to 2.81 visits amongthose who have never smoked(n=42; p=0.048). They alsovisited the doctor more onaverage over the study period(160.20 visits compared to126.02; p=0.006) and averagedmore specialist fee items (251.48compared to 235.60; p=0.009).Neither amount smoked nornumber of years as a smokerfurther affected utilization rates.

• Increased socio-economic statuswas associated with a decreasein overall MSP visits and inspecialist fee items (p=0.001 andp=0.002, respectively). Thisassociation was only true amongthe study group.

• Length of implantation did notsignificantly affect either totalMedical Services Plan visits orspecialist items. However, therewas a significant decrease inhospitalizations among thosewho had their implants for morethan 10 years compared to thosewho had received their implantsfive years ago or less.

• Dow Corning breast implantswere associated with morehospitalizations than were MentorCorporation breast implants. DowCorning manufactured mostsilicone gel-filled breast implantswhile Mentor manufactured mostsaline-filled implants. However,as discussed above, type ofimplant does not account for thisdifference in manufacturerresults.

Overall, the role of potentialconfounders seemed to be interesting,but minimal. Those variables that didaffect utilization rates did so in veryspecific ways and often only in veryspecific relationships. They were rarelyoverarching, affecting all areas, allyears, or all women.


VII A. Overview

This study sheds new and interesting light on a question thatseems to have no easy answers. Although the results may besubject to sample bias, they do indicate that breast implantationis related to increased use in key areas of the British Columbiapublic health care system.

Women in this study who had undergone breast implantsurgery visited significantly more doctors and more specialiststhan their counterparts who had not received these implants.They were more than four times as likely to be hospitalized (OR= 4.26, 95% CI = 2.58, 7.02), and the number ofhospitalizations they experienced over the study period wassignificantly higher than was experienced by women in thecontrol group.

There were other differences in health care utilization patterns.Women who had received breast implants accessed slightlydifferent specialists and hospital services than did women whodid not. They were more likely to be admitted to hospitalelectively (OR = 1.90, 95% CI = 1.50, 2.39) but less likely to beadmitted urgently (OR = 0.60, 95% CI = 0.46, 0.78) or in anemergency (OR = 0.53, 95% CI = 0.35, 0.79). The study groupwomen seemed to spend slightly less time in hospital than didthose in the comparison group, a relationship that was stable,although not statistically significant, over the years.

There are also similarities in health care utilization patterns.The main difference in services provided in hospital was in thegreatly increased need for plastic and general surgery servicesand for gastroenterology services. Other hospital services andhospital physicians were distributed in very much the same waybetween the two groups. Likewise, there was no difference inthe proportions of women from the cohorts in the different

Discussion


hospital levels of care, nor was hospitallength-of-stay significant.

Type of implant did not significantlyaffect utilization rates, indicating thatwomen who have received salineimplants are no less likely than womenwho have received silicone gel-filledimplants to experience this increasedneed for public health care services.Similarly, other implant factors andlifestyle factors did not appear to besignificant confounders. (Smoking was afactor that increased health careutilization, and future research couldinvestigate this possible confounderwithin both study and comparisoncohorts.)

B. External Validity

The study results must be interpretedwith caution, and in full light of thechallenges and limitations encountered.

In terms of generalizability, the studygroup is made up almost entirely ofCaucasian women who speak Englishas their primary language, which meansthat although the results can perhaps begeneralized to other women in thisgroup, the results may not be applicableto women of other ethnic groups.

There is also the issue of sample biasthat comes from relying on a self-identified study group. This couldsignificantly skew the results and reducegeneralizability to the general populationof women with breast implants. As theentire population of women withimplants cannot be observed, the extentto which this bias is or is not presentcannot be evaluated.

The potential for such bias may be lesssignificant than it could have been. Asthe questionnaires show, most of thewomen participating in this study did notconsider themselves to be in poorhealth. Quite the contrary, they felt thattheir health is good or excellentcompared to other women their age(although half reported being diagnosedwith a chronic illness and one-quarterfelt that health problems subsequent tobreast implantation had caused them tolose or quit a job). The results alsoindicate increased need only in veryspecific areas; areas that are related towell-documented breast implant-relatedcomplications. These factors indicatethat the study group is not significantlybiased either towards sick or healthywomen.

That being said, a self-identified study

Women in this study who had undergone breast

implant surgery were more than four times as likely to

be hospitalized than the women who had not received

these devices.


sample is often subject to some samplebias, especially in an area as charged asthis one is. That being the case,generalizations and conclusions aboutcausality must be cautious and limited.

C. Internal Validity

Past studies have reported that womenwith breast implants have differentcharacteristics (e.g., more alcoholicdrinks, more sex partners, and dyinghair more often) than do non-implantedwomen (Cook et al., 1997). Thesefactors are potential confounders thatcould not be considered in this study,given the anonymity of the comparisoncohort. This research was able toexamine some lifestyle, demographicand implant factors among the women inthe study group, and found that thesefactors did not, in general, markedlyaffect health care use. Differences inthese areas between the study andcomparison groups, therefore, would not

be responsible for the observed results.

D. Health Trends

Are increased visits among women whohave received breast implantsindications of poorer health or just ofmore questions or concerns about theirhealth? Or are they related to specifichealth concerns?

The increased utilization observed inthis research is not simply a matter ofperceived need, as could be the case ifonly ambulatory visits (MSP data) wereinflated. In an increasingly strict healthcare climate that discourageshospitalizations for all but those in mostserious need, women with breastimplants are using more of theseservices more often. And, given thespecific areas involved, this increaseduse is a direct consequence of theirprivately-funded surgery.

In an increasingly strict health care climate that

discourages hospitalizations for all but those in most

serious need, women with breast implants are using

more of these services more often. And, given the

specific areas involved, this increased use is a direct

consequence of their privately-funded surgery.


This study is probably too small to pickup differences in health care utilizationdue to systemic illness, given the rarityof classic autoimmune or connective-tissue disorders, and given that this typeof illness probably affects only a subsetof women with breast implants (althoughthere was an observed associationbetween breast implants and use ofgastroenterology services – arelationship that was stable acrossseveral analyses and should thereforebe explored further). The results supportthis, indicating increased utilization inareas and time frames that would beassociated with local rather thansystemic complications. The high rate ofsuch problems is well known, and thuswe cannot minimize the large – andgrowing – number of women who willrely on the public health care system toa greater extent following breast implantsurgery.

E. Future Research Directions

This study opens many avenues forfuture research. Further study in thisarea of health care utilization wouldserve to expand on the results observedhere and could delve deeper intospecific health consequences.Additional examination with larger studysamples and, once a breast implantregistry is established, random studysamples are highly recommended.

This research does not answer thequestion of causality. It does not tell uswhy breast implantation results in

increased public health system use, onlythat it does. Assumptions can be madebased on breast implant knowledge andliterature, but additional study is neededto further examine and explain thereasons for this increased use—tobetter understand it and thereforeaddress it.

Certain variables also bear closerexamination. For example, hospitallength of stay results proved to be veryinteresting. Days of care in hospitalwere shorter (though not significantly)among the women with breast implants.This trend is likely related to the types ofservices they are accessing in hospital,and thus could be an indication of thespecific health care problems that arecontributing to increased need forservices.


The results from this study indicate that undergoing breastimplant surgery does affect health care system utilization. It isassociated with increased doctor’s visits and increasedhospitalizations.

Breast implant surgery is not deemed medically necessary andis performed – and paid for – privately in the vast majority ofcases. However, it appears to directly contribute to anincreased need for public health care services among thewomen receiving these devices. If, as the literature suggests,serious local complication rates are at least 25% (Gabriel et al.,1997, p. 677) – and more likely are 50% or higher (Sarwer etal., 2000, p. 847)– there are many thousands of women inBritish Columbia who are using greater health care resourcesas a result of this surgery.

This study makes no claim to be able to ascertain or predicthealth outcomes subsequent to breast implantation. However,it does tell us with confidence that women who have undergonethis surgery use the publicly funded health care system morethan women of the same age and region who have not.

This study points the way towards more research in order tomore definitively and completely investigate the health careutilization patterns of women with breast implants and to betterunderstand the causal relationship between breast implantsand health care use. This research and that to follow will helpguide women in their decision-making and governments in theirpolicy-making.

Conclusion

VIII


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Terry, M.B., Skovron, M.L., Garbers, S., Sonnenschein, E., &.Toniolo, P. (1995). The estimated frequency of cosmetic breastaugmentation among U.S. women, 1963 through 1988.American Journal of Public Health, 85(8), 1122-4.

Tinkler, J.J.B., Campbell, B.H.J, Senior, J.M., & Ludgate, S.M.(1993). Evidence for an association between implantation ofsilicones and connective tissues disease. London: UKDepartment of Health, Medical Devices Division.

United Kingdom Independent Review Group. (1998). Siliconegel breast implants: The report of the Independent ReviewGroup. Retrieved March 13, 2000, from http://www.silicone-review.gov.uk/

Vanderford, M.L., & Smith, D.H. (1996). The silicone breastimplant story: Communication and uncertainty. Mahwah, NJ: L.Eribaum Associates.

Wall, W., Martin, L., Fritzler, M.J., &. Edworthy, S. (1995). Non-fasting chylomicronaemia in breast implant patients. Lancet,345(8961), 1380.


WebMD. (2001). Connective Tissue Disease. RetrievedOctober 3 2001, from http://my.webmd.com/content/healthwise/123/30568

Wilson, L. (1995). A woman in my position: The politics ofbreast implant safety. Toronto: NC Press.

Young, V.L., Hertl, M.C., Murray, P.R., &. Lambros, V.S.(1995). Paecilomyces variotii contamination in the lumen of asaline-filled breast implant. Plastic & Reconstructive Surgery,96(6), 1430-4.

Zimmerman, S.M. (1998). Silicone survivors: Women’sexperience with breast implants. Philadelphia, PA: TempleUniversity Press.


Appendix 1: Public Service Announcement

Are you interested in helping us learn more about breast im-plants? We are looking for volunteers for a research project onthe use of the health care system by women who have or haveever had breast implants. Your confidentiality will be guaran-teed. If you have ever had breast implant surgery and areinterested in taking part in this research project, please contactAleina Spigelman at the Centre of Excellence for Women’sHealth at Children’s and Women’s Health Centre of B.C. at(604) 875-2280.


Appendix 2: Informed Consent Letter andForm

Consent FormHealth Care Utilization for Women Who Have Undergone

Breast Implant Surgery

Dear friend,

This letter outlines a research project in which we hope you willagree to participate. Below we describe the project and explainwhy your participation will be of great value to this study. Weexplain the process that will be used to ensure that your identityand the information you provide is kept strictly confidential.Please read the project outline carefully. Two copies of aconsent form are attached to this letter. If you are willing to bepart of this study, please complete one copy and return it to usin the envelope provided. The second copy is for you to keepfor your own records. If you have any questions or concernsplease feel free to contact the project coordinator, AleinaSpigelman at (604) 837-4800. Thank you for your time andinterest.

Project Overview

A team of health care consumers and medical researchers arestudying how women who have undergone breast implantationsurgery use health care services as compared to women whohave never had such surgery.

We want to know if there are differences in the rates of healthcare service use between women in these two groups. Wewant to know how women use both the publicly-funded healthcare system (e.g., family physicians, hospitals, specialists) andother forms of health care (e.g., counselors, herbalists,massage therapists) that are paid for privately. We are alsointerest in women’s use of “alternative” or “complementary”


therapies.

From this study, we hope to betterunderstand some of the consequencesof breast implantation surgery and thehealth care needs of women who haveundergone such surgery. This in turnmay help researchers identify, preventand find better treatments for sideeffects of this surgery.

Description

We will compare two groups of women.The study group will be made up ofwomen who have undergone breastimplant surgery and who are willing toparticipate in this project. The controlgroup will be made up of women whohave never had such surgery.

We are asking that women who havehad breast implant surgery give us theirpermission to use their Personal HealthNumbers (PHNs) to access health careusage data available in the B.C. LinkedHealth Database. This Database linksinformation about consumer activity andhealth care provider services in theMSP, Hospitalization, Continuing Care,Deaths and Births and Pharmacaredatabases.

Once we have your permission, we willsubmit your PHN to a databasemanager at the Ministry of Health inVictoria, B.C. This person will scrambleyour PHN to ensure confidentiality andthen will forward the number (withothers) to the Centre for Health Services

and Policy Research (CHSPR) at theUniversity of British Columbia.

Once the Centre for Health Servicesand Policy Research receives thescrambled PHNs, it will in turn obtainpermission from the Ministry of Health toextract the data from the B.C. LinkedHealth Database. Our research teamwill have access to these data for alimited period of time for analysis.

The study group will also be sent aquestionnaire that will takeapproximately 20 to 30 minutes tocomplete. This questionnaire will askquestions about you, your lifestyle andyour implants. It is intended to provide amore complete picture of health careusage. It will also help us to determine ifthere are any differences dependant onage, location, ethnicity, socio-economicstatus, type of breast implant, and soon. No identifying information will beasked, and the results of thequestionnaires will be kept strictlyconfidential.

Confidentiality

If you agree to participate in this study,you will not be identified personally inthe analysis or reported findings. We willensure confidentiality through severalmethods:

♦ Names, addresses and PersonalHealth Numbers (PHNs) will beseparated from all otherinformation. Only the research


team leader will ever see theidentifying information. She willassign file numbers, and anyinformation (including theutilization data andquestionnaires) contained in thefile will always be kept separatefrom names and addresses.

♦ All information (names,addresses, PHNs, utilization data,questionnaire responses, etc.) willbe kept locked in filing cabinetsand computer files will be securedby password.

♦ The B.C. Ministry of Health willreceive only PHNs and filenumbers, with no other identifyinginformation. When the Ministryreceives this list, it will use acomputer program to scramblethe PHNs so that they cannot beused to trace the identity of theperson. Only then will the Centreof Health Services and PolicyResearch (CHSPR) have accessto the numbers. The Ministry doesnot keep either list (of scrambledor unscrambled PHNs).

♦ The questionnaires will beidentified by file number only –never by name.

Permission

We hope that you will agree to be part ofthis important study. In order tounderstand the impact of breast implant

surgery on women’s health, we need toknow how if affects women’s use ofhealth care services, both traditional and“alternative.” We hope we have yoursupport and cooperation.

If you are willing to be part of this study,please complete one copy of theattached consent form and return it to usin the envelope provided. Please keepthe other copy for your own records.

Please note that if you agree to be partof the study, you can withdraw thatpermission at any time. You have theright to refuse to participate and towithdraw your participation without anynegative consequences to you.Refusing to participate or withdrawingfrom the study will not in any wayjeopardize any future treatment ormedical care you need.

If at any time you have any concernsabout your rights or treatment asparticipants in this project, you maycontact Dr. Richard Spratley, Director ofthe UBC Office of Research Servicesand Administration at (604) 822-8598.

Risks and Advantages

There are no immediate benefits thatthis project will provide to you. However,there are also no risks and there may belong-term benefits. This project mayprovide important information that willbenefit all breast implant consumers inthe long run.


Thank you for your time in reading thisletter. We believe this project is animportant step in the search for moreinformation about breast implants andtheir effects on women.

If you have any questions or concernsabout this project, please feel free tocontact the project coordinator, AleinaSpigelman at (604) 837-4800.


Consent Form

I, (full name) , givemy permission to the researcher identified above to use my Personal Health Numberto access my health care utilization data. I understand that the researcher guaranteesmy confidentiality and that the methods outlined in the above letter will be followed toachieve this guarantee. Only the research leader (Ms. Aleina Spigelman) will haveaccess to the key that links my questionnaire and utilization data with my identifyinginformation.

The data collected will be used to examine the health care utilization of women whohave undergone breast implant surgery and will be compared to the health careutilization of a group of women who have never had such surgery.

I understand that a questionnaire will be sent to me to ask about other health careutilization.

_____________________________ _______________________________ Participant Signature Witness Signature

_____________________________ _______________________________ Participant Name (please print) Witness name (please print)

_____________________________ _______________________________ Date (day/month/year) Date (day/month/year)

Address: ___________________________________________________________(Apartment) (Street)

___________________________________________________________(City) (Province)

___________________________________________________________(Postal Code) (Country)

Phone number: (_________) _________-____________

Personal Health Number: _________ _________ _________

I have received a copy of this consent form


Appendix 3: Health Practices Questionnaire

Health Care Utilization for Women Who Have Undergone Breast Implant Surgery

Health Practices Questionnaire

Name: _________________________________________

Address: _________________________________________

_________________________________________

_________________________________________

_________________________________________

Personal Health Number: _________________________


Health Care Utilization for Women Who Have Undergone Breast Implant Surgery

Health Practices Questionnaire

Demographics: Please tell us a bit about yourself.

1. Date of Birth (day/month/year): _______/_______/_________

2. Where do you live?Major city (E.g., Lower Mainland, Victoria)Small city outside of Lower MainlandRural area

3. Ethnicity (please check one):CaucasianAsianIndo-CanadianFirst NationsAfrican-CanadianOther (please specify) _______________________________________

4. What language do you speak at home? (Please check one)EnglishFrenchCantoneseMandarinOther (please specify) _______________________________________

5. What is your marital status? (Please check one)Married/Common-lawSeparated/DivorcedSingleWidowed

6. What is the highest education level you have completed? (Please check one)Less than high schoolHigh SchoolSome post-secondaryPost-secondary degree


7. Do you have any children?No, noneYes, 1-2Yes, 3-4Yes, 5 or more

Implants: Please give us some information about your breast implants.

8. Why did you get breast implants?Cosmetic augmentationReconstruction after mastectomy for malignant disease (e.g., cancer)Reconstruction after other mastectomy (e.g., breast cysts, prophylactic)Augmentation for non-development of one breast/both breastsOther (please specify) ________________________________________

9. How many breast-implant-related surgeries have you had after your initial breastimplantation surgery?

NoneOneTwoThreeFour or more (If more, how many? __________)

10.Have you ever had to replace one or both of your breast implants?NoYes, oneYes, both

a. If yes, how many times have they been replaced?OneTwoThreeFour or more (If more, how many? __________)


11. Have you ever had a silicone implant of any kind other than breast implants(e.g., hip replacement, chin implants, etc.)?

NoYes

If yes, what type of implant(s)? __________________________________

For the next questions, please provide information for each set of breast implants youhave had (if you have had more than four sets of implants, please use a separatesheet of paper).

1#teS 2#teS 3#teS 4#teS

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Type of Breast Implant 1. Silicone gel-filled 2. Saline filled 3. Bi/Double/Triple lumen 4. Meme (coated with Polyurethane foam) 5. Dacron patch 6. Other (please specify) 7. Don’t know

Breast Implant Manufacturers 1. Dow Corning 2. Mentor 3. McGhan 4. Other (please specify) 5. Don’t know


Health: Please tell us a bit about your health.

16.Compared to other women your age, how would you describe your health atthis time?

ExcellentGoodFairPoor

17.Have you been diagnosed with a chronic illness? (If more than one, please useseparate paper)

NoYes (please specify) __________________________________________

a. If yes, in what year was this illness diagnosed? __________

18.Have you ever lost your job or had to quit your job or reduce your hoursbecause of health problems?

No, neitherYes, lost my jobYes, reduced my hoursYes, quit my job

a. If yes, was this before or after you got breast implants?BeforeAfterDon’t know

19.Have health problems interfered with your ability to do housework orrecreational activities?

No, neverYes, occasionallyYes, often

a. If yes, was this before or after you got breast implants?BeforeAfterDon’t know


Health Behaviour: Please tell us a bit about activities that might affect yourhealth.

20.Do you exercise regularly?NoYes

a. If yes, how many times per week?One or two timesThree or more times

21.Have you ever smoked?NoYes If yes, when did you start (year)? __________

22.Do you still smoke?No If no, when did you stop (year)? __________Yes

23.If you have ever smoked, how much do/did you smoke per day?Less than ½ pack per day½ to 1 pack per dayMore than 1 pack per day

24.Approximately how many alcoholic drinks do you have per week? (One drink isone bottle of beer, one five-ounce glass of wine or one-and-a-half ounces ofhard alcohol.)

None1 to 23 to 56 to 1011 or more


Health Services: Please tell us about private health services you use.

25.Have you ever sought alternative health care services, that is, services not paidfor by your medical services plan (e.g., acupuncture, homeopathy, etc.)?

NoYes

a. If yes, what alternative health care services have you used?________________________________________________________________________________________________________________________________________________________________________________________________

26.Have you ever accessed health care services outside of Canada?NoYes

a. If yes, in what country(ies)? ____________________________________b. If yes, in what year(s)?

____________________________________c. If yes, what service(s) did you access?

________________________________________________________________________________________________________________________________________________________________________________________________

Thank you very much for your time and effort. If you have any further commentsrelated to your health care usage or your breast implants, please feel free to add anycomments to the end of this survey, or attach additional pieces of paper.If you have any questions, please contact Aleina Spigelman at (604) 837-4800 or byemail at [email protected].


Appendix 4: B.C. MSP Subsidy Codes andStatistics Canada Low-Income Cut-Offs

The Low-Income Cut-Offs (LICOs) are published by StatisticsCanada. Families living below these income levels are consid-ered to be living in “straitened circumstances.” The LICOs aremore popularly known as Canada’s poverty lines. They mea-sure relative rather than absolute poverty.

Although Statistics Canada avoids referring to the LICO as the“poverty line”, researchers have long used the LICO to identifythe population living “in poverty” and to measure changes inthis population over time.

From: Canadian Council on Social Development, www.ccsd.ca

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9991 688,71$ 143,51$ 532,51$ 671,41$ 163,21$

8991 175,71$ 070,51$ 569,41$ 429,31$ 241,21$

7991 904,71$ 139,41$ 728,41$ 697,31$ 030,21$

6991 231,71$ 496,41$ 195,41$ 775,31$ 938,11$

5991 478,61$ 374,41$ 273,41$ 373,31$ 166,11$

4991 115,61$ 261,41$ 360,41$ 680,31$ 014,11$

3991 284,61$ 731,41$ 930,41$ 360,31$ 093,11$


The British Columbia Medical Services Plan provides MSP subsidy assistance toindividuals whose net income from the previous year falls below certain levels, lessdeductions for family size, age and disability.

*Temporary premium assistance is offered to individuals due to unexpected hardship who do not qualify for themaximum level of assistance based on the previous year’s income.

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Advisory Committee

Aleina Tweed (néeSpigelman)Research Assistant, BreastImplant Centre, BC Women’sHospital and Health Centre

Ann Pederson, MScManager, Policy andResearch, British ColumbiaCentre of Excellence forWomen’s Health

Linda WilsonConsumer Advisor

Lorna TaylorConsumer Advisor

Jama RussanaConsumer Advisor

Dr. Leanne ReimchePrivate Practice, InternalMedicine

Joy LanganConsumer Advisor

Dr. Arminee KazanjianAssociate Director, Centre forHealth Services and PolicyResearch, University of BritishColumbia

Patti Janssen, PhDResearch Associate, BCWomen’s Hospital and HealthCentre

Karen Heiberg, MACounsellor, Breast ImplantCentre, BC Women’s Hospitaland Health Centre

Dr. Patricia ClugstonMedical Director, University ofBritish Columbia BreastReconstruction Program

Dr. Penny BallemHaematologist, Vice PresidentServices, SpecializedWomen’s Health andReproductive Health, BCWomen’s Hospital and HealthCentre

Dr. Milton BakerPrivate Practice, InternalMedicine & Rheumatology

L’utilisation des soins desanté chez les femmes quiont subi à une interventionchirurgicale destinée àl’implantation d’uneprothèse mammaire

Les femmes qui ont subi à une intervention chirurgical

destinée à l’implantation d’une prothèse mammaire

utilisent-elles le système de soins de santé public plus

souvent ou différemment en comparaison des femmes

qui n’ont jamais subi une telle chirurgie? La présente

étude offre un aperçu de la santé des femmes qui ont

subi une intervention chirurgicale destinée à

l’implantation d’une prothèse mammaire et des

conséquences inhérentes à une chirurgie privée

(relevant d’un financement privé) sur le secteur public.

Centre d’excellencede la C-B pour lasanté des femmes

Vancouver, C-BCANADA

health care utilization among women who have undergone€¦ · hospital, study group and comparison...

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