BREAST IMPLANT NEWS
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.