FDA Considers Silicone Breast Implant Registry

The FDA recently considered available data and the return of silicone breast implants during an advisory panel meeting. As noted in our post below, advocacy groups called for an outright recall or withdrawal of silicone implants due to a complete failure by manufacturers to provide the minimum data required to allow their sale. Following the 1992 ban of silicone implants, manufacturers were required to provide safety and efficacy data from ongoing studies. In June the FDA confirmed that breast implants were not ‘lifetime devices’ and that they required monitoring and replacement. A prior bulletin confirmed a potential association between silicone breast implants and ALCL (Anaplastic Large Cell Lymphoma).

In “FDA Questions Studies of Breast Implant Safety”, S. Reinberg, reports on the background highlighted above. It is also noted that 5-10 Million women worldwide have implants. This particular story does not highlight the explicit failure of manufacturers to follow women with breast implants. However, the hearings revealed that manufacturers followed, and thus reported on, only some of the women enrolled in studies. WebMD Health News, “FDA Questions Studies of Breast Implant Safety: Ongoing Safety Studies Have Lost as Many as 79% of Enrolled Patients”, by B. Goodman, noted that 3 years into the studies MENTOR had lost contact with 79% of women enrolled in their MEMORY GEL study. ALLERGAN had lost nearly 40% of their study, designed to follow NATRELLE recipients, after only 2 years. Based upon claims by their manufacturers, these gaping holes in surveillance are not expected to stop the return of silicone implants.

REUTERS is reporting that post-hearings a registry of patients will be developed to monitor women that elect to have silicone breast implants. This measure may encourage women to stay informed and provide ongoing data to both the manufacturers and the FDA. However, the recent hearings show that manufacturers were able to convince the FDA to allow the return of silicone implants on limited data and without their being held accountable for their own failure to follow or monitor patients. How you can claim to lose contact with the majority of patients in a study, given the availability of e-mail, cell phones and social media, defies conventional logic.

Consumer Advocates Want Silicone Breast Implants Recalled

As noted in prior posts below, #saline breast implants have been given a seal of approval by the FDA based upon data provided by manufacturers regarding their safety and efficacy. The once banned implants have returned as an option for women. However, during recent meeting of an FDA advisory panel consumer advocates were renewing calls to have the silicone implants banned or recalled. In “Consumer Groups: Stop Sale of J&J Breast Implants”, REUTERS reporter, A. Yukhananov, reported on the National Organization for Women Foundation and the National Research Center for Women and Families appearance at the two-day FDA advisory panel meetings to discuss needed follow up studies for silicone implants. This story notes that Johnson & Johnson’s “Mentor” unit, and Allergan’s, silicone implants were approved conditionally approved for sale in 2006. However, the companies were required to follow 40,000 women, for 10 years, to monitor and report on safety issues. The story cites Allergan as having collected preliminary data for only 60% of participants and J&J’s Mentor as collecting only information on only 21% of women over a 3 year period. Notably, J&J has been plagued by a company wide pandemic of recalls over the past two years across a number of markets and divisions. Their failure to obtain data on these women raises more red flags about institutional controls and could contribute to more scrutiny of their safety record. The American Societ of Plastic surgeons estimates that in 2010, 400,000 women underwent breast enlargement or reconstruction in the US.

In 1992, the FDA had banned silicone breast implants over safety concerns. Final recommendations on how to move forward are expected following the conclusion of these hearings. For now, company representatives are making excuses about why they could not follow up with women that initially enrolled in their studies. However, with the availability of e-mail, digital technology and social media you have to openly wonder about their commitment to follow women for adverse events, as well as transparency in reporting their results. Read More...