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Congresswoman Rosa DeLauro

Representing the 3rd District of Connecticut

DeLauro Calls for Investigation into Safety of Breast Implants

February 7, 2011
Press Release

Washington, DC— Congresswoman Rosa DeLauro (CT-3), Ranking Member on the Labor, Health, and Human Services Appropriations Subcommittee, sent a letter to Jeffrey E. Shuren, M.D., Director of the Center for Devices and Radiological Health at the Food and Drug Administration, calling for a public Advisory Committee meeting to release information about potentially dangerous saline breast implants and silicone gel implants.

A recent FDA review showed a possible association between saline and silicone gel-filled breast implants and a rare kind of cancer, anaplastic large cell lymphoma (ALCL). The review also highlighted potential problems with the FDA’s approval process, which depend on post-market analysis administered by the companies that manufacture the implants. Many companies lose track of patients or fail to complete these studies, and the FDA has no recourse.

Congresswoman DeLauro asks for information about how post-market studies, which were critical to the FDA approval of saline breast implants, are conducted and their impact on the results.

The text of the letter is below.

February 7, 2011

Jeffrey E. Shuren, M.D. Director, Center for Devices and Radiological Health Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Dear Dr. Shuren: I am writing to strongly urge the Center for Devices and Radiological Health (CDRH) to hold a public Advisory Committee meeting this year that would release all available information about the 10-year post-market study results for saline breast implants, and also make available all results for the post-market Core studies and large long-term study of silicone gel implants. The Food and Drug Administration’s recent announcement about the rare form of lymphoma that may be associated with breast implants serves as a stark reminder that post-market studies are especially important for all implanted devices that are intended to remain in the body for many years.

While recognizing that the new lymphoma findings never would have been discovered in post-market prospective studies, regardless of how well the studies were conducted, the findings do raise important questions about whether the appropriate outcome measures are being examined in the required post-market studies. The findings also raise the question of whether patients who become ill or have their implants removed for any reason are being appropriately evaluated in these studies. For example, if a woman is diagnosed with ALCL and has her implants removed, or if her implants are removed due to pain or any other reason, is it possible that she could be lost to follow-up and not analyzed in one of the post-market studies? These would be useful questions for an Advisory Committee to review. It would be critical that such an Advisory Committee be truly independent and comprised of unbiased scientists with no financial ties to implant companies or the implant procedure.

As you know, most breast implants are often implanted in young women, many in their early 20s, and most women intend to keep them for the rest of their lives, removing and/or replacing them only when absolutely necessary. Because of this, it is essential that women know as much as possible about the potential risks associated with having such implants for 50 or more years.

As a cancer of the immune system which involves inflammation and is sometimes characterized by rheumatological symptoms, the ALCL finding also raises questions about the possible long-term risks of other conditions and diseases. For example, in the two-year data on silicone breast implants that were submitted to FDA and discussed at the FDA Advisory Committee meeting in 2003 and 2005, FDA scientists reported a statistically significant increase in several connective tissue disease symptoms such as chronic fatigue and joint pain for augmentation patients and reconstruction patients with Inamed/Allergan gel implants, and these increases were significant even when the woman’s age was statistically controlled. Yet, these data are virtually impossible to find on the FDA web site and there are no follow-up data provided on those same symptoms from the post-market studies. As a result, it is not possible to know if those same connective tissue symptoms were measured for all 10 years of the study, or if any effort was made to determine if women with those symptoms remained in the study or not. Please update me on any follow-up information on those symptoms for the following eight years of the study.

While there are numerous breast implant studies that are often quoted as indicating no risk of autoimmune or connective tissue diseases, it should be noted that almost all of those studies were funded by the manufacturers or others with financial ties to breast implants. In contrast, there are several studies suggesting an increase in long-term autoimmune symptoms, and in light of the lymphoma findings, those studies deserve further attention.

Thank you for your thorough response to my October letter regarding the post-market follow-up studies of breast implants. However, I remain concerned that these studies never will provide the kind of information about long-term risks that all patients deserve, and that physicians need to provide appropriate informed consent and medical care for their patients.

As you acknowledged in your letter, the Allergan and Mentor large-post-approval 10-year studies are well below target. While both companies achieved the first step of recruiting more than 41,000 patients each, each company only was able to submit data to FDA for less than half the patients by the one-year mark; Mentor’s loss of three out of four of their patients is especially disturbing. These statistics would suggest a lack of commitment to these studies by both companies.

Understanding that FDA urged both companies to do a better job, and assuming that the next annual report from the companies will show some improvement at the two-year mark, I remain skeptical about the usefulness of the results of these very important studies, given this extremely poor beginning. According to Yale scientists, longitudinal clinical trials use many strategies to reduce “loss to follow-up,” such as providing free medical visits to coincide with follow-up data points or, if necessary, offering a modest “honorarium” to participate in follow-up interviews or medical visits. Major device companies that are highly motivated to maintain their samples would incorporate these methods in order to conduct adequate post-market studies. Since breast implants were approved under the condition of these post-market studies, have the companies been warned that FDA approval could be rescinded if the studies are not properly conducted?

Prior to your leadership at CDRH, the Center allowed the same companies to lose track of approximately half the patients in their saline implant studies. There were 901 Inamed/Allergan augmentation patients and 1246 Mentor augmentation patients in the original samples, compared to the final samples of 520 and 651 respectively. This loss of almost half the patients is not considered an adequate follow-up for samples of young, healthy patients, and raises serious questions about the results of the studies. If a woman had her implants removed because of illness or problems, was she kept in the final analysis of the data, or dropped from the study? Clearly, any woman who had problems should have been included in the final analyses. Did FDA inquire as to what incentives the companies or physicians provided to keep patients in those studies, and what effort was made to determine if patients who dropped out of the studies had more health problems than those who remained?

It is for the reasons outlined above that I urge CDRH to hold an Advisory Committee meeting this year that would make this information public. Two years after saline breast implants were approved, the FDA held a public Advisory Committee meeting to discuss the 5-year research results. Silicone gel implants were approved in 2006. It would be completely appropriate to for CDRH to convene such a meeting to provide all available information about the 10-year results for saline breast implants, and all available results for the long-term study of silicone gel implants.

I also urge you to invite patient and health advocacy organizations that have long been involved in this issue to participate fully in the meeting, in a meaningful way. It has been reported that in previous meetings, Advisory Committee members would reach a point when they would begin to ‘tune out’ the testimony during the public comment period because it consisted of several hours of patients and advocates rushing through statements to meet the imposed time limits on individual speakers. I think you would agree that there should be a more appropriate way to treat patients and nonprofit organizations that have spent years examining breast implant research, such as Public Citizen, National Research Center for Women & Families, National Women’s Health Network, and others. These groups should be included as invited speakers and be afforded the opportunity to arrange for a patient panel to express their concerns.

The FDA should consider ways to improve public input on any issue pending before the agency very seriously, whether it involves patients and non-profit groups or the manufacturer. Convening an Advisory Committee meeting that would make public post-market study information on breast implants, as well as including invited presentations from individuals and nonprofit organizations who are most knowledgeable about the issue would go a long way toward that goal.

Thank you very much for your consideration of this matter. I look forward to your response to my request and to the questions outlined in the letter.

Sincerely,

ROSA L. DeLAURO Ranking Member House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies