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Wednesday, September 7th, 2011
Silicone-gel breast implants will remain on the U.S. market while manufacturers work to boost participation rates in required long-term studies, a Food and Drug Administration official said Thursday, as a spokesperson for the agency stated that the FDA continues to believe currently approved devices are safe and effective, but need better long-term follow-up.
The FDA advisory panel began meetings last 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. 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.
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 also 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 will 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. Dr. Aston performs breast augmentation in New York, New York and participates in the post-approval studies for silicone gel-filled breast implants.