Improving Medical Implant Performance Through Retrieval Information: Challenges and Opportunities - by Terrie Cowley on Jan. 11, 2000

I am here today to represent the TMJ Association as co-founder and President. We began in 1986 as a local support group in Milwaukee. We are now a national non-profit patient organization dedicated to education, research, and service on behalf of all who suffer from temporomandibular joint diseases and disorders, commonly referred to as TMJ. Many in our Association are implant patients so I am especially pleased that the organizers have invited me to speak at this very important conference.

Most patient organizations start as grass roots movements by people affected by a serious health problem or by their loved ones. They are driven to do something about it-learn more, develop a support network, advocate for basic and clinical research, deal with reimbursement issues. The aim is to do whatever it takes to find solutions. So it is with our organization. We state that our mission is to improve the care and treatment of those affected by TMJ diseases and disorders through research and education, with the ultimate aim of preventing these craniofacial problems. And we add a vision statement - to create a society in which TMJ patients are treated with understanding, dignity, and compassion.

That vision statement is especially apt, because the history of TMJ implants is one in which patients have been sorely mistreated, neglected, dismissed, and abandoned. Because so many of our members have been implant recipients we have gathered an enormous body of information, not only from the patients themselves, but from providers and scientists, from reviews of the scientific literature, from professional organizations and from documents procured through the Freedom of Information Act. Patients are a primary source of information. They tell us their history, provide details of the craniofacial destruction and the systemic complications they are experiencing. We also learn such things as what information was relayed to them by one federal agency or another, which medication seems to help the pain, which manufacturers have sent new but distressed devices to the patient in lieu of their explanted one, we sometimes even hear of how this implant experience has brought families closer together and we also learn which patients have died. Though important and documented, this information is no substitute for an implant registry.

Our role is not only to document what has happened and what is still happening. We are implementing an educational program, publishing materials and making them available on our Web site. We are developing a network of regional support groups where TMJ patients and families can meet to exchange information. We have expanded our newsletter and will shortly launch a journal with lay versions of quality scientific articles. We are sponsoring our first annual interdisciplinary basic science meeting in Bethesda this May at the Federation of American Societies of Experimental Biology. We are building a database of information that we are gathering from a patient questionnaire. We have pilot tested the questionnaire with 150 patients approximately half of whom have had implants. In addition patients desperately seeking help have sent us their medical records and even implants hoping we can help them, because no else is listening. So you can see this organization has become a central resource and has the capability of bringing the issues that are important to the patients to the development of an implant registry. The information we receive is empowering us to take action to "clean up TMJ." We are proud that our past accomplishments and activities have led to a congressional hearing, a technical conference, appropriations report language urging research. There are no more passionate advocates for research than those who need it most.

Without understanding the patients' perspective on the problems in the medical device system, you may not fully perceive the urgency we feel that solutions must be found. From the many who call, write, or E-mail us, we continue to hear the horror stories of some of the worst medical devices ever to be marketed.

Implants manufactured by Dow Corning and Vitek Company were intended to replace the natural disc between the jaw bone and the skull. What had been sold to the patient as a cure for jaw joint pain and dysfunction became worse than the disease. The TMJ implant disaster is a case study of how government, professional, and business entities failed to protect TMJ patients in this country. It is also an example of how the division of labor, inherent in the medical device field, left no one accountable to the patients for the damage caused and no one responsible for the financial burden of lifetime of medical care.

PROBLEM - No one was responsible for notifying the patient of a Class I FDA recall

Shortly after a Class I FDA recall on the Vitek devices, Vitek's president, Charles Homsy, moved his patents, his assets, and himself out of the country. The company declared bankruptcy, making no efforts to inform customers or patients of the recall. The FDA could find no patient records at the Vitek company site and claimed that budgetary restrictions prohibited widespread publication of the recall.

The FDA then asked the American Association of Oral Maxillofacial Surgeons to send the names of their Vitek recipients to a Medic Alert Registry. From more than 5,000 surgeons contacted, only a handful responded, yielding 230 names. Evidence strongly suggests than many oral surgeons never attempted to notify their patients. This observation is most troubling from an ethical and health policy perspective, for the surgeon was the one the patient returned to time and again for treatment. Typically, patients who presented with implant failure symptoms underwent another procedure while often being blamed for causing the problem or told there were no problems and referred for psychological counseling, or were simply abandoned. Surgeons' offices lost medical records, x-rays and devices.

Had an implant registry been in place in 1983 at the implantation of the first Vitek device, evidence of material abrading and joint destruction would have been available within six months and further use of this product halted. A minimum number of patients would have been harmed and all would have been notified. As it was, the Vitek implant remained in use until its recall, seven years later. Similarly, had a registry been in place in the 70's when Silastic was being implanted, it would have been obvious that this type of material would not stand up to the loads on the TMJ joint. Even now, ten years after the recall, our Association hears from patients who have just learned they have or had a defective implant.

PROBLEM - The lack of basic and clinical studies relating devices to health problems

The absence of basic and clinical studies on the relationship between a medical device and disease or health problems that manifest in the patient before and after implantation throughout the life of the patient is an act of negligence by the medical device industry. To implant a medical device into the human body and allow it to remain there for years without monitoring a patient's health status is to ignore a vital component of medical research. The time is long overdue for the medical device industry to be based on medical device science and for the industry and the NIH take device-related health problems seriously by developing and supporting research programs to understand the effect of materials and material particles on the human body. A registry, complete with a patient's health information before implantation, would enhance the knowledge base about the disease for which the implant was used and shed light on biocompatibility factors and post-explantation complications. TMJ patients appear to be suffering a multitude of medical problems for years after implant removal.

PROBLEM - No one was responsible for the patients' financial burden

A sample of implant patient costs - a surgical revision procedure can range from $8,000 to 101,000. Several weeks ago a patient told us the total joint she received cost $16,000. Additional hospital expenses were $55,000. Our pilot survey results show the average out-of-pocket expenses for implant patients was $42,017. Seventy-eight percent of TMJ implant patients reported that their ability to work or attend school was affected. This means career plans were destroyed and earning capacity diminished. People become disabled and care providers are required. Homes are mortgaged, parents' pension funds lost to medical care. Others are forced into bankruptcy. Eventually and inevitably, this becomes society's problem. The Judicial System has in most cases failed the implant patients. Resolution of the issue of who compensates the patient harmed by medical devices is also overdue. I recommend that an implant compensation fund supported by manufacturers be developed. Such a fund was set up by pharmaceutical manufacturers to compensate those who have suffered ill effects from vaccines. Congress should allocate funds to the FDA budget for compensation to recipients of a device that received FDA approved, in the event it is subsequently found to be not safe and effective. Public Policy would require research and database development and accessibility to related information.

PROBLEM - Patients were the last to know of the defective devices

Many people knew the TMJ implant would fail years before the patients, yet did nothing to stop the harm. In the 1960's DuPont, a component part supplier knew that Vitek, whose president was Dr. Charles Homsy, a former employee, was going to use FEP film as the meniscus replacement in manufacturing TMJ implants. They also knew of the inherent weaknesses in that product as described by their own chemist. In a 1984 letter, a clinical consultant to Vitek, warned Dr. Homsy of a "calamity of unbelievable proportions" based on the excessive wear of the material. Yet, he actively marketed and used the material until the recall. The FDA was advised of the danger of Vitek implants in 1987 from surgeons at Travis Air Force Base. No investigation was conducted. I am told that materials scientists and engineers, over the years, had "knock down drag out" arguments with Dr. Homsy over the use of Proplast-Teflon in a load-bearing joint. In a 1984 letter to an oral surgeon from a Dow Corning Project Engineer, he expressed reservations about using Silicone in the temporomandibular joints, given the severe mechanical stresses of that joint. Yet Dow Corning sought and received FDA approval on a TMJ specific implant in 1985. Even the National Institute of Dental Research told a congressional committee investigating TMJ devices that they were opposed to implants and therefore never funded studies on TMJ implants. A prestigious manufacturer proudly told me that he never allowed a member of his family or an employee to have a TMJ implant. He told me this a month after Christine Hodgeson died. No one told her. No one told the unsuspecting public.

I believe I have presented compelling evidence for the establishment of a retrieval and analysis implant registry. Drs. Fielder and Black wrote, " Routine device retrieval and analysis is essential to performance evaluation, which, in turn, is essential to good patient care." We may add that it may make the difference between numbers of patients who suffer harm and even between life and death. If you argue that the numbers of failures are minimal, and you don't have an implant registry, how do you know? The failure is magnified if there is only one - and it is your child, your loved one, or yourself. If you think a registry is not affordable, we say you cannot afford not to do it.

A mandated patient implant registry is essential for physicians and surgeons to "First, do no harm," fundamental to safeguarding patient health, well-being and interests, and vital in protecting patient rights. Patients have a right to know whether a medical implant device works and is safe, when an implant device fails or causes harm and when an implant device has been recalled. The patients are the greatest stakeholders in this medical device venture. The patients' contributions to this implant registry can become a source of tremendous vitality and innovation to the medical device system.