an impending crisis involving biomaterials

_______________________________ EDITORIALS

An Impending Crisis Involving BiomaterialsJ. Donald Hill, MDDepartment of Cardiac Surgery, California Pacific Medical Center, San Francisco, California, and The Society of ThoracicSurgeons Representative to the Biomaterials Availability Coalition

An impending threat to the availability of the rawbiomaterials used in the manufacture of implant­

able medical devices is fast becoming a reality.Because of massive class action suits over bodily inju­

ries alleged to have been incurred from silicone breastimplants and prosthetic temporomandibular joints, theproviders of raw biomaterials to device manufacturersare threatening to withdraw entirely from the medicalmarket. Medical/legal settlement costs in the billions ofdollars compared with revenues of less than one milliondollars per year in the medical raw biomaterials markethave forced the hand of these suppliers. This is not anunreasonable business decision.

United States legal precedent* permits an individualwho has suffered bodily injury from a product to sue allparticipants involved in the manufacture of the product.In medicine this applies to the suppliers of componentsor biomaterials for device manufacture.

In 1992 the suppliers of raw biomaterials informedmedical device manufacturers that they were withdraw­ing from the medical device market for all implantabledevices and some temporary devices. However, theywould continue to provide biomaterial quantities equiv­alent to past manufacturer purchasing patterns up to 36months to allow time to develop alternative sources. Thedeadline for receipt of biomaterials is December 31,1995.

The raw biomaterials involved include but are notlimited to silicone, polyethylene terephthalate (Dacron),polytetrafluoroethylene (PTFE, Teflon), polyacetal (Del­rin), and polyurethane. These polymers are necessary forthe fabrication in part or in whole of heart valves,oxygenators, pacemaker leads, implantable defibrillators,vascular grafts, intraaortic balloons, heart pumps, esoph­ageal stents, tracheostomy tubes, and other devices. Mostimplantable devices used in other surgical subspecialtiesare affected similarly.

Approximately 7.5 million patients each year will beaffected by this action. Due to either unavailability of

Address reprint requests to Dr Hill, Department of Cardiac Surgery,California Pacific Medical Center, 2100 Webster St, Suite 512, San Fran­cisco, CA 94115.

* McPherson vs Buick, 1916 New York Supreme Court; Devlin vs Smith,1882 New York Supreme Court; Thomas vs Winchester, 1852 New YorkSupreme Court.

© 1994 by The Society of Thoracic Surgeons

medical devices or the necessity to use inferior alternatetherapies, morbidity and mortality will increase sharply.We no longer will be able to offer our patients the currentstandard state-of-the-art care. Biomaterials that havebeen used with extraordinary success in medicine fordecades will be in diminishing supply unless somethingis done immediately.

Options for alternate sources were explored. Nonewere feasible for a variety of reasons. The most commonof these was the lingering liability risk or the 5 to 8 yearsnecessary to qualify new sources of the same polymer ornew biomaterials through the regulatory process of theFood and Drug Administration to establish safety andeffectiveness, a necessary and important process that wedo not want to sidestep in seeking a solution.

In early 1994, with the deadline of December 1995approaching, 14 surgical subspecialty societies formed anindependent coalition (Biomaterials Availability Coali­tion) to be the advocate for their patients, to inform thepublic of the situation, and to assist in the formulation offederal legislative reform. A position paper was draftedby the Biomaterials Availability Coalition describing thesituation more fully and is available through The Societyof Thoracic Surgeons headquarters.

The cornerstone of the solution to this problem lies inlegislative reform. In cooperation with other interestedparties a senate bill has been written and sponsored. Thebill S.2215 "The Biomaterials Access Assurance Act" willlimit liability to the level of the device manufacturer, whowill bear the entire burden of quality assurance. Anyclaim against a supplier of raw biomaterials or devicecomponents would be presented in a pretrial motionwhere a judge would determine the supplier's degree ofresponsibility for inclusion in the suit.

Through federal statute, this legislation will providebroad legal protection for raw biomaterial suppliers, whoonly in exceptional circumstances bear any accountabil­ity for device design, safety, and effectiveness but repre­sent the "deep pockets" that are the favorite entree ofhungry litigators.

"The Biomaterials Access Assurance Act" will be in­troduced in the United States Senate early in 1995. Whencalled upon, the membership of our society must beprepared to lend support in assuring its passage.

Ann Thorac Surg 1994;58:1571 • 0003-4975/94/$7.00