FDA General and Plastic Surgical Devices Advisory Committee
August 30-31, 2011
Testimony given by Kate Ryan, representing Breast Cancer Action
Good afternoon. I’m Kate Ryan and am here today on behalf of Breast Cancer Action, a national education and advocacy organization that carries the voices of people affected by breast cancer to inspire and compel the changes necessary to end the epidemic. BCAction has over 35,000 members nationwide who believe that patients should come before profits.
Breast Cancer Action has a formal Corporate Donations Policy that precludes our accepting donations from any company that might present a conflict of interest, including all health industries, pharmaceutical and medical device companies, and any business whose products increase the incidence of cancer.
BCAction has been testifying at these meetings on behalf of women seeking safe and effective reconstructive surgery for many years. It has now been twenty-five years since FDA declared SBI’s a Class III device, and in that period, weak attempts have been made to conduct sound research with adequate follow-up to assess the implants’ safety.
Even the two gold standard studies of the implants, the bedrock of the Institute of Medicine report on the devices, have major shortcomings. The Nurses’ Study was beset by conflict of interest and dismissed major women’s concerns as outcomes. The Mayo Clinic study likewise did not examine systemic conditions such as fibromyalgia as an endpoint. Both studies openly acknowledge that, despite their large sample sizes, they were not large enough to detect significant effects of the implants on low prevalence outcomes.
We are very pleased that the FDA is beginning to take post-marketing surveillance seriously, particularly for the products whose manufacturers promised Phase IV studies as a provision of their approval.
We have reviewed the interim findings, released in June, provided by FDA with data from Mentor and Allergan on their SBI’s. Research by the two manufacturers provide possibly the best data set on the devices that we have, given that they are prospective studies. Nevertheless, we have considerable concerns about the inability to maintain participation in the studies and of the shocking incidence of rupture and resurgeries, particularly for women who have used the implants for reconstruction of their breast following mastectomy.
Follow-up rates in the two Large Studies are dismal. Seventy to eighty per cent of the women in Mentor’s large study have been lost to follow-up after three years. Geographic relocation should not be the hurdle it once was with the availability of the internet to find individuals contact information.
Although Allergan’s follow-up rates in their Large Study are disappointing, they are considerably better than those of Mentor, and an examination might be able to discern the differences between the two companies’ approaches. As it is, the available data cannot be considered valid with such skimpy returns.
Rupture, resurgery, and removal rates are higher for women using the implants for reconstruction than they are for women who are augmenting their breast size. This is not surprising, given age and health differences between the two groups, and was well known at the time that the devices were approved for marketing by the FDA. At that time and still, Breast Cancer Action thinks that these indications of device failure are far too high for the FDA to dismiss them by concluding that the silicone gel-filled implants “have a reasonable assurance of safety and effectiveness.”
In general, the tone of the FDA’s report was reassuring, but the reassurance was not evidence-based. For example, reoperations within two to three years of implantation approached 40% of participants in both Core Studies, Yet the FDA summarized this finding by declaring that “[the] majority of SBI patients in the Core Studies did not require reoperation.”
Little was mentioned in FDA’s June report about the small study of physician-provided informed consent, but what is evident is that doctors are still reluctant to provide their patients with easily available written information that may influence decisions whether or not to undergo breast implant surgery.
We appreciate the FDA’s plans for oversight in these Phase IV studies, and applaud your work with the companies to strengthen their research efforts, but are skeptical that this will be enough to provide the needed information.
In conclusion, Breast Cancer Action continues to believe that silicone gel-filled breast implants are an ineffective and potentially unsafe option for reconstruction after mastectomy, and urges FDA to reconsider their broad availability.