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Spinning the Silicone Web of Illusion

















AUGUST 1, 1995



Mr. Chairman, my name is James S. Benson. I am senior vice president for technology and regulatory affairs of the Health Industry Manufacturers Association (HIMA).


I appreciate this opportunity to testify on the risk assessment standards used by FDA in evaluating medical devices. In my testimony today, Mr. Chairman, I want to leave this Subcommittee with three points:


   * First, one of the most essential materials in medical implants, silicone, has been unfairly accused as being unsafe, though decades of successful use and a growing volume of research substantiates the  appropriateness of its use in the body.

   * Second, the vilification of silicone is one of the primary causes of the current shortages of many raw materials which are essential to the development of new medical products;

   * Third, these shortages present a threat to the health of hundreds of thousands, perhaps millions, of patients because technology manufacturers may not have the materials they need to develop countless life-saving technologies.

I recognize, Mr. Chairman, that the focus of much of this hearing will be on breast implants. But, for two reasons, my remarks today will not focus on these products -- nor on the companies that produce them: First, as former Acting Commissioner of the FDA and former Director of the Center for Devices and Radiological Health, I am precluded by law and by ethical considerations from discussing proprietary information. But in addition, I want to use my brief time today to address some of the deeper questions of risk assessment and science at the agency that I believe hold implications for patient care and health that go well beyond the breast implant controversy.


HIMA Represents Medical Devices, Diagnostics, HIS


For those members of the Subcommittee who may be unfamiliar with HIMA, let me explain who we are and who we represent.

HIMA is the national trade association of the medical technology industry. It represents more than 700 manufacturers of medical devices, diagnostic products, and health information technologies.


During the past 20 years, these medical technologies have revolutionized medicine. Thanks to achievements in such fields as fiberoptics, imaging, electronics, and biotechnology, today's medical technologies are faster, more efficient, and more productive than ever. But most important, such products -- be they lasers, scalpels, MRIs, home diagnostic tests, pacemakers, or a myriad of other products -- have substantially improved health care for patients.


As I noted, many of these medical devices depend upon a variety of biomaterials, including silicone -- which is one of the most pervasive of all synthetic materials and is used widely in various forms (solids, liquids, gels) in countless medical and non-medical products. It is used, for example, in such products as toothpaste, soft drinks, deodorants, and pain relievers, as well as in a range of medical products, including  

catheters, artificial joints, and shunts. Were it not for substances like silicone and other biomaterials, much of the progress in medicine that each of us takes for granted would not have occurred.


Risk Assessment at FDA


Your chosen topic of risk assessment at FDA, Mr. Chairman, is of significant interest to virtually every manufacturer of medical products.


All of the technologies developed by our industry must be reviewed by the Food and Drug Administration or must otherwise adhere to the rules and policies established by FDA. As such, our members are fully familiar with FDA procedures and requirements regarding risk assessment. As former Acting Commissioner of FDA and Director of the Center for Devices and Radiological Health -- the office responsible for device review at the agency -- I, too, am familiar with FDA procedures on risk assessment.


I commend your Subcommittee for examining this issue because I believe FDA's risk assessment policies -- in many important ways -- lie at the heart of the problems I noted a moment ago.


Let me begin by providing a baseline for understanding just what risk assessment at FDA is and what it means. As members of the Subcommittee may be aware, the Federal Food, Drug, and Cosmetics Act (FFDCA, Section 513a1C and Section 515d2) requires that FDA must find a reasonable assurance of safety and effectiveness before approving a new product. Note that the term Congress chose was reasonable; not absolute, not perfect, but reasonable.


To meet that standard, medical technology companies perform a variety of tests and studies on their products. Depending on the type or nature of the product; how it is intended to interact with the body; the disease or condition it is intended to diagnose or treat; or how it will be used, where, and by whom; those tests might include:


   * Bench tests, in which the products are put through a range of mechanical, structural, and chemical examinations.

   * Mathematical or computer modeling, in which the product is simulated to undergo a variety of conditions which mimic virtually any human environment.

   * Animal studies, in which the product or component material is tested in animals in which certain biological responses are physiologically similar to those of humans.

   * Long-term or short-term clinical trials, in which the product is studied over a period of time in human subjects.

   * And tests to determine how devices directly affect the tissues they contact and, conversely, how the tissues and body fluids affect the device.


The testing process often takes many years. It involves many physicians, scientists,  engineers, and biomedical specialists. It involves the collection and analysis of laboratory data and clinical results. And it may require millions of dollars to complete.


Yet even the most rigorous testing, Mr. Chairman, does not, and cannot, yield assurance of absolute safety. Despite years of vigorous, aggressive, and persistent scientific inquiry, testing of any device cannot yield absolute assurances about risks because science itself rarely, if ever, yields absolute answers. By its very nature, science is open-ended. It is on-going. It is never complete. No matter how thorough the testing, one can always ask one more question, study one more patient, seek one more statistic. And when that is done, you can do it again.


That is especially true when someone is trying to prove a negative absolute -- in other words, that absolutely no risk exists. The universe of evidence required for such proof is virtually limitless. So scientific inquiry must be content with finding a reasonable indication of the probability of something good or something bad happening as the result of a medical intervention.


Therefore, the standard I cited a minute ago that Congress gave to the agency and to the industry for deciding what is clinically safe and effective is especially important. Congress clearly recognized the nature of science -- and at the same time,  the need for new products to reach patients within a finite period of time -- and concluded in 1976 that the agency should not seek absolute assurance of safety and effectiveness of medical devices, but should seek a reasonable assurance of safety and effectiveness.


Congress said, in effect: We know science can never reach absolute determinations. So let us be reasonably certain. By using this standard of reasonable assurance, patients will ultimately be better served.


Translated into everyday terms and into the context of today's hearing, this guidance means that FDA must make a judgment as it examines the kinds of studies I noted earlier. It must examine the risks and the benefits reasonably and objectively and then make its judgment on the balance between risk and benefit.


That is: The agency must ultimately ask, "Does the potential positive impact of the device on health outweigh its potential hazards?" Stated somewhat differently: "Are the predicted risks judged to be low enough in light of the predicted benefits?" The job of FDA is not to hold up a product indefinitely while demanding evidence that exceeds the standard of reasonable assurance.


I want to be clear, Mr. Chairman, that my goal today is not to blast the agency. Our industry believes the agency has an important role to play in regulating medical devices. At the same time, it is also accurate to say that the agency has suffered from a kind of "absolutist" mentality in the recent past -- characterized by an insistence that data demonstrate the precise or absolute determination of risk of a product or prove with total certainty that a product will or will not have a specific effect. If that certainty is not there, the agency too frequently concludes that the data are inadequate and, therefore, patient access must be delayed or denied.


Yet this approach is fraught with danger. Carried to its extreme, it would stop virtually all products because, as I have said, absolutes in science generally cannot be achieved.


That means patients would be harmed because they would be denied access to the latest life-saving and life-improving devices. And if that happens, Mr. Chairman, the quest for absolutes in protecting public health will, in itself, have become a threat to public health. That is exactly what Congress was trying to avoid when it crafted so carefully the wording of the statute in 1976.


Now let me turn from past to present. We have today what I believe to be an almost perfect example of this demand for "absolutes." I want to draw it to the Subcommittee's attention because I believe it is central to FDA's approach toward risk-assessment and the long-term implications of that approach.


As members of the Subcommittee are well aware, the breast implant controversy of recent years raised alarms about the safety of silicone. As you may know, Mr. Chairman, silicone is one of the basic raw materials used in medical implants and in a variety of everyday commodities. Because it is often used in devices that augment or replace body organs or functions and that come into prolonged contact with body tissues, we must have reasonable assurance of its safety.


As you also recall, the breast implant controversy has prompted some to foster a perception that silicone is unsafe, dangerous, and harmful, though the greater weight of scientific and epidemiological evidence is clearly on the side of safety. Regrettably, silicone has been vilified with no basis in sound science.


As a result of this controversy, many scientific and clinical studies were developed to explore the safety of silicone. Specifically, their goal was to examine whether a link existed between silicone and the development of connective-tissue diseases in breast implant patients. In recent months, many of those epidemiological studies have reported results.


So far, some 17 of these studies have reached the same conclusion: They do not find a link between silicone and connective-tissue diseases. These are studies that have been done by some of the world's leading institutions, such as Harvard University, the Mayo Clinic, Johns Hopkins University, and Emory University. And they have been published by some of the most prestigious, peer-reviewed medical and scientific journals, such as the New England Journal of Medicine, Journal of Clinical Epidemiology, Annals of Rheumatic Disease, Journal of the National Cancer Institute, and others.


In the June 22, 1995, issue of the New England Journal of Medicine, for example, the authors of the Harvard study said this: "In a large cohort study, we did not find an association between silicone breast implants and connective-tissue diseases...." That is essentially what the other studies are finding as well.


In addition to these studies, FDA's counterpart agencies in other countries have conducted their own analyses and literature reviews. These include agencies in the United Kingdom, Australia, and New Zealand. None of these institutions -- I repeat, none of these institutions -- is finding a link between silicone and connective tissue disease.


I quote Dr. Kenneth C. Calman, Chief Medical Officer of the UK Medical Devices Agency, as he summarized his agency's findings: "The conclusion...was that there was no evidence of any association between breast implants and connective tissue disease...."


Now, do these numerous studies mean that we are absolutely certain that there is no link between silicone and such diseases? No. As I said, even here, one could always insist on more. If the study had 1,000 participants, why not 2,000? Why not 10,000? If it was a year long, why not two years? Why not 10 years? And so on.


But do we have reasonable assurance that there is no link on the basis of these studies? The answer is yes. The evidence to support that point is more than sufficient if your standard is a reasonable assurance of safety and effectiveness. And I believe that is the standard we must use because it is the standard which reflects truly appropriate reliance on science. It is that standard which is consistent with the expectations that Congress wrote into the law. And it is that standard, finally, which reflects simple, common sense.


Despite this growing body of evidence from all of these prestigious institutions and from all of these FDA counterparts in other countries, we find that the FDA, as well as some observers, continue to refute these findings. They point to statistical and other alleged scientific limitations.


Yet many of these observers were more than willing to suggest in the past that silicone might harm patients. They arrived at that conclusion without pointing to any data or any proof to support it. My question is this: How many studies, done by how many institutions, and reinforced by how many government health agencies will it take to convince FDA? In effect, FDA absolutism in risk assessment is alive and well -- at least when it comes to silicone.


Let me add an additional, somewhat ironic, counterpoint to this absolutism.  Despite the anguish and passion prompted by the use of silicone in some medical technologies, silicone is one of the most ubiquitous, pervasive substances in our society. It has been thoroughly tested in laboratory animals for ingestion and implantation.


In addition, each of us uses and ingests silicone in one form or another every day -- perhaps every minute of every day. We use it in deodorants, sun tan lotions, and pain relievers. We use it in toothpaste, lip balm, and shaving creams. We use it in soft drinks, hamburgers, and French fries. We use it to treat colds, burns, and allergies. And, of course, we use it in and on a variety of medical treatments. It is the lubricant on every catheter and hypodermic needle -- substantially reducing the discomfort of  such injections as a result -- and it is the substance of many medical implants.


Let me present this point another way: Go to the grocery store and you'll find shelves of products that use silicone, from condoms to antacids. Go to the drug store and the fast food restaurant, and you'll find silicone. In effect, silicone has been used in virtually every aspect of human behavior for decades.


As a result, there is an enormous body of empirical evidence from years and years of continuous use that one must recognize and that one cannot discount. In light of this, silicone -- perhaps like few other products or substances -- really can be dubbed "tried and true." If any significant danger existed from this substance, it would have become extremely obvious a long, long time ago.


But the fact is, what the Harvard and Hopkins and New Zealand studies are showing is correct: The allegations about silicone in breast implants are untrue and lack foundation.


As a matter of fact, what all of these data are beginning to show is that silicone -- at least as far as medical technology is concerned -- has been wrongly accused. Yet now that the juries from Harvard and Mayo and the UK are providing more than adequate assurances, the FDA refuses to act on the results.


Impact of Unsubstantiated Accusations Regarding Silicone


My purpose in providing this background, Mr. Chairman, is not to present an educational treatise on the arcane elements of scientific reasoning or on the potential applications of a particular polymer. My purpose is to point out that this perception of silicone as being unsafe, together with FDA's unwillingness to acknowledge studies of the highest caliber, is having an increasingly negative and harmful impact on patient care.


Let me underscore a critical point: I am not referring here to breast implants. In fact, this goes well beyond breast implants. I am referring to the fact that availability of one of the most critical raw materials, silicone -- which is essential to countless medical devices and everyday applications, from soft drinks to toothpaste -- is seriously threatened.


More broadly, what I am also talking about is the fact that allegations about the safety of silicone -- unsubstantiated allegations -- have become the centerpiece of widespread product liability litigation and publicity in this country. Medical device companies and suppliers of raw materials for medical devices have become the subject of growing litigation. At the heart of the litigation, of course, lie the unfounded charges about the health risk associated with silicone.


This type of litigation has led many suppliers of such materials to simply leave the medical device market. And it's not surprising as to why. Under current U.S. product liability law, the supplier of any commodity material that is used in a medical device -- no matter how unrelated the supplier is to the design, sale, or manufacture of the device -- can be brought into a lawsuit involving a device that has allegedly failed. Yet despite this enormous liability exposure, the sale of such materials represents a minuscule fraction of the business of these suppliers. The annual sales of polyester yarn to the medical market, for example, is estimated at less than $200,000, while sales to other industries are estimated at $9 billion.


Consequently, the obvious recourse has been to withdraw many of these biomaterials from the device market. During the past three years, suppliers such as Dow Corning, Dow Chemical, and DuPont have all done so. This is clearly a rational business decision by raw material suppliers who must balance the revenues they receive from the device market against the liability exposure they incur.


As many of these raw material suppliers leave our industry, medical device makers are facing growing shortages of vital raw materials. A recent study of the device industry by the Wilkerson Group found that 41 percent of companies interviewed said they were having difficulty obtaining raw materials as a result of supplier concerns over product liability. Among companies producing implantable products, 73 percent said they had difficulty obtaining raw materials.


Device companies are responding to these shortages in a variety of ways. Some are stockpiling resources that are still available. Some are seeking alternative suppliers or trying to redesign products, thereby expending resources that could be used to develop new products. And some are simply dropping projects altogether.


In some cases, alternate suppliers that have been identified for certain materials have also expressed liability fears. And in many cases, no other suppliers may exist.


The effect of this shortage on patient care could be devastating. The range of materials being restricted is vast and will affect the entire spectrum of medical specialties, from cardiology and neurology to urology and ophthalmology. To give you some sense of the magnitude, consider the types of life-saving and quality-enhancing products that depend upon biomaterials. These products are either being affected by these shortages already or could be affected by them in the near future:


   * Heart valves, which are used to control the flow of blood to and from the heart and between chambers of the heart. Some 35,000 patients receive heart valves annually.

   * Vascular grafts, which repair or replace arteries in people whose own arteries have been injured or are in danger of catastrophic failure.  Approximately 300,000 patients benefit from vascular grafts annually.

   * Pledgets, which are surgical tools that buttress fragile tissue for suturing. It is safe to estimate that millions of patients benefit from their use every year.

   * Intraocular lenses and related technologies used in cataract surgery. Some 1.5 million patients annually are affected by these products.


Let me stress that the products I've just listed are comprised of a variety of biomaterials. But let me also point out a number of the critical medical devices that depend upon silicone in particular.


   * Hydrocephalus shunts, which drain the build-up of cerebrospinal fluid from the brains of affected infants. About 75,000 shunts are implanted annually.

   * Arthroplasty devices -- such as artificial toe joints and finger joints and artificial knees -- which help 600,000 patients per year.

   * Catheters, which are used in about a million patients annually.


And this is just a start. Other products that would be significantly affected if silicone is totally withdrawn from the market include IV drip systems, pacemaker leads, implantable infusion pumps, wound drainage sets, wrist joint replacements, ostomy systems, and any number of grafts. In fact, for some medical products -- such as cardiac pacemaker leads and hydrocephalic shunts -- silicone is the only approved material available for production.


Given the potential impact of restricted access to such materials, Mr. Chairman, HIMA commissioned a study that forecast how certain shortages might affect patients, innovation, and product development. In the short term -- that is, within approximately 1-3 years -- the forecast found that:


   * Many small companies, which are the prime innovators in our industry,      will be forced out of business because of the costs of managing such      shortages.

   * U.S. manufacturers will have to direct resources away from R&D on new      types of products to search for replacement materials.

   * Foreign competitors will be able to focus on production of entirely new kinds of medical products, thereby seizing this country's  competitive edge in many critical technologies.


But in the longer term -- that is, within 3-10 years -- the study projected that:


   * Inventories will have diminished and a full-force biomaterials embargo  -- touching the very products I mentioned a moment ago and many more -- could hit the device industry.

   * Patients will face shortages of vital medical implants.

   * Materials that have enjoyed some 40 years of beneficial use will completely disappear.

   * Major segments of the medical implant industry will move overseas.

   * The U.S. will lose its leadership in medical implants.


These are sobering conclusions Mr. Chairman. They hold implications for jobs, for trade, for economic growth, for competitive leadership, and -- most importantly -- for the continued patient health of this country. And these very issues -- the fear over litigation, the shortages that result, the threats to innovation -- begin, ultimately, in the kind of absolutist thinking that today pervades our product liability law and FDA's regulatory risk assessment.


The roots of this issue run deeply into the obvious contradiction by FDA and others that, on the one hand, convicts silicone before all the facts are in but, on the other, refuses to exonerate silicone in the face of growing proof of its innocence. And it is this absolutist  attitude that unleashes a powerful and continuing chain reaction -- a chain reaction that begins with unsubstantiated allegations, which themselves lead to widespread lawsuits, which then lead to wide-spread publicity and public belief in the allegations, which then lead to growing shortages. And it is these shortages which ultimately threaten this industry's ability to provide the medical treatments necessary to protect the public health.




Let me turn for a moment from problem to solution, Mr. Chairman. I recognize that I have touched on many disparate themes in describing a most complex problem. But let me outline a series of steps that we believe can begin to address these challenges. These are not sweeping, quick-fix answers. Instead, they address various pieces of this complex issue and, together, form the basis of a long-term solution.


Congress must pass biomaterials legislation.


First, we urge Congress to pass legislation now contained in House and Senate-passed product liability bills that would prevent a public health crisis by encouraging biomaterial suppliers to remain in the medical device market.


The specific legislation incorporated in the product liability bills is the Biomaterials Access Assurance Act. This legislation was introduced by Sen. Joseph Lieberman (D-CT) and Sen. John McCain (R-AZ), as well as by Rep. George W. Gekas (R-PA), and was ultimately incorporated into product liability legislation passed by both chambers. It has attracted strong bipartisan support. Rep. Dennis Hastert (R-IL) led an impressive array of Commerce Committee members in embracing these protections for raw material suppliers in the product liability measure.


The bill would be an important element in addressing the biomaterials crisis because it would limit the liability of raw material suppliers to instances of genuine fault. In effect, this change would reduce the likelihood that these companies would be burdened with unwarranted or catastrophic lawsuits where they have met their contractual agreements and strictly adhered to contract specifications.


But the bill would not in any way diminish the existing liability of medical device manufacturers -- that is, of the members of our industry who use these materials in their products. As a result, the bill would not diminish the ability of consumers to seek redress against appropriate parties for harm alleged to be caused by an implant.


But we believe it would keep the biomaterials suppliers in the medical implant market and would encourage others to enter it. As such, this legislation would play a key role in addressing an acute health care crisis by ensuring that a continuing supply of vital raw materials is available.


We urge the House and Senate leadership to act quickly to pass product liability legislation this year to avert this crisis.


FDA must reverse its course on silicone.


In addition to encouraging Congress to adopt biomaterials legislation, Mr. Chairman, we also believe it is time for FDA to reverse its historical course on silicone. As I have shown, reliable, respected, and thorough scientific research is making clear that unsubstantiated allegations about silicone are not accurate.


It is time to accept these findings and to defuse the passion that has, too often, surrounded this substance and has snowballed into the longer-term problem I've described. Reversing the silicone conviction, as it were, is another vital component in reducing the pressure on raw material suppliers to flee the medical implant market.


I might add that we hope FDA will begin to show the same kind of openness in this area that it has shown in another critical aspect of this issue -- that is, in helping smooth the regulatory hurdles for manufacturers' use of silicone from alternative sources. The FDA Center for Devices and Radiological Health worked closely with HIMA to develop clear parameters for establishing the equivalence of silicones from alternate sources.


Following that work, HIMA submitted to the Center a materials analysis paradigm that it had developed with the intent of making the materials acceptance process more systematic. FDA has agreed to work with us to develop this concept further. Continuing in this cooperative mode, I recently received a letter from Dr. Bruce Burlington, director of the Center, offering to work with and assist HIMA in addressing the potentially increasing numbers of materials shortages that could be generated by concerns over current market withdrawals and the Dow Corning bankruptcy filing.


FDA must abandon absolutism in risk-assessment.


I would also like to add another suggestion in this mosaic of solutions to the biomaterials crisis and risk assessment issue. That is, we urge the FDA to abandon its absolutist attitude on risk assessment generally and return to the standard of "reasonable" assurance of safety and effectiveness that the Congress wrote into the original medical device law and that remains a sound base for policy and regulation today.


FDA must recognize that absolutes are not achievable, and that the quest for absolutes holds the potential for harming patients. Only by adhering to the standard of reasonableness can we expect to encourage continued innovation and continued investment in innovation. And only by adhering to this standard can patients expect to receive timely access to new medical advances.


With respect to silicone in particular, a reasonable analysis must take into account the long-term, wide-spread empirical data from millions of uses in all aspects of everyday life -- from toothpaste to French fries. These aren't narrow studies. This is real-life -- and it must be taken into account.


FDA must view product approvals as a key element of consumer protection.


More broadly speaking, Mr. Chairman, our industry would also like to encourage a fundamental change in FDA's -- and society's -- view of consumer protection and public health.


There are those who believe that consumer protection only means protecting consumers from unsafe products -- and that is certainly an important aspect of this issue. It is also one that we strongly support. But too often, we overlook another important aspect of consumer protection. That is, consumers are protected when companies bring forward new products that attack disease, that make people healthier, and that often save lives.


We believe FDA must realize that getting new, safe, and better treatments to the bedsides of patients can be just as critical in promoting better health, as keeping unsafe products off the market. The fact is, we need both. This new focus should become a central tenet of FDA's entire risk assessment philosophy and day-to-day operations.




In conclusion, Mr. Chairman, such relatively arcane subjects as risk assessment, absolute vs. reasonable assurance, and the details of legislative intent are sometimes overlooked in the heat and passion of the debate over breast implants. While not dismissing in any way the importance of the breast implant debate, we believe that these deeper issues hold enormous meaning for how and if new products are developed, for whether innovation can continue to progress, and for whether patients -- and future generations of patients -- can continue to receive the implants and other medical technologies they need.


Without a doubt, FDA has a clear obligation to calculate risks, or potential risks, with regard to the safety of products. But as part of that, FDA should do everything within its power to debunk junk science. If we are truly to protect public health, we need an even-handed, objective, and rational FDA approval process that ultimately rests upon sound science and common sense.


There is no question that such an approach, with regard to the issues surrounding silicone, requires the agency to stand up and reassure the public of the safety of silicone and use of silicone in all of its forms. It is time for FDA to bring common sense into its views on silicone and to accept the convincing, respected, and comprehensive evidence that is now available.


Attention to this and all the related issues we have raised today is not a luxury, it is an absolute necessity. Nothing less than the future of patient health hangs in the balance.





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