The FDA’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee conducted a hearing on August 30-31 in Gaithersburg, Md., to evaluate the progress of long-term post approval studies mandated when silicone gel-filled breast implants were approved by the agency to return to market in 2006.
A United States FDA advisory panel began a two-day meeting this week on silicone breast implants to consider ways to improve the effectiveness of the implants’ post-approval safety studies. After being banned for 14 years, the FDA in 2006 re-approved Allergan and Johnson an Johnson’s Mentor silicone gel-filled breast implants for breast reconstructive surgery and for breast enlargement in women aged 22 and older.
Such implants had been banned because of concerns about possible links to systemic diseases, including cancer and lupus, which have never been substantiated with the wealth of data accumulated on the devices over the years. However, when the FDA lifted its ban on silicone implants it did so with conditions stating that breast implants did sometimes cause adverse effects, and were not lifetime devices. Because of this, they required manufacturers to do studies on the implants’ safety and performance after their approval.
As we already knew, study findings announced earlier this year did not show an increased risk of breast cancer or connective tissue disease, although FDA officials noted that longer studies were needed. Although the FDA has also recently cautioned that breast implants might be linked to a higher risk of a rare form of lymphoma called anaplastic large cell lymphoma, officials called those chances slim. The safety findings were based on preliminary data from six ongoing post-approval studies conducted by Allergan and Mentor, the only two companies that make silicone implants for sale to physicians in the United States.
Common issues surrounding silicone gel-filled implants include fibrous capsular contracture, or hardening of the capsule around the implant, the likely need for future surgeries and possibly even implant removal. Other possible complications include implant rupture, wrinkling, breast asymmetry, prominent scarring, pain and infection.
But Allergan and Mentor acknowledged problems with low patient follow-up in their post-approval studies. Allergan’s response rate for the post approval studies was 60% and Mentor’s was 21% (described as being so low due to the fact that the study was initially termed “mandatory” and then made voluntary, leading to many patients to defect from the study).
Presently, the FDA recommends that women follow-up regularly with their plastic surgeon, MRIs to detect potential ruptures (probably overkill as MRI’s are expensive and insurance won’t cover them for random checks without cause of possible rupture). Patients should aslo pay attention to any changes and notify their surgeon if they notice any unusual symptoms such as pain, asymmetry or swelling, and educate themselves on the signs and symptoms of complications.
The FDA said it wants to find ways to improve post-approval safety studies and new approaches to mandate studies for the surveillance of silicone implants. Silicone implants are the most studied medial device in the history of modern medicine, so it wil be interesting to see how the FDA will go about this to yield any new or useful information on the very popular medical device that around 400,000 women per year get in the United States.