FDA confirms safety of silicone breast implants
September 8, 2011
Don’t be surprised to see silicone-gel breast implants in the news again. The FDA put silicone implants back on the market in 2006 with the proviso that implant makers, Mentor and Allergan, perform long term studies on their safety. But, unfortunately, women have walked off into the sunset with their newly-formed breasts. They have not complied with the FDA-mandated long term studies designed by implant makers.
After two days of discussion about how to improve study compliance, Dr. William Maisel, chief scientist for the FDA, reaffirmed that silicone breast implants are safe. But everyone involved is intent on getting women to follow up, so that the safety of these implants is reaffirmed.
Both Mentor and Allergan each enrolled about 40,000 patients in studies. But according to msnbc.com, August 31, Mentor has three-year data for only one out of five women in its study, while Allergan has two-year data for three out of every five.
In spite of FDA-generated letters to plastic surgeons and patients, stressing the importance of follow-up, patients did not comply adequately. The recent two-day panel, including implant sponsors, professional organizations, patient advocacy groups, patients and physicians, explored reasons why.
Dr. Jeffrey Kenkel, professor and vice chairman of the Department of Plastic Surgery at the University of Texas, Southwestern Medical School at Dallas and president of the American Society of Aesthetic Plastic Surgery said, “Multi-investigators have a difficult time getting patients who are feeling well and back to their normal routine after surgery to come back in for their follow up.” Also, it is not typical for silicone breast implant patients to follow up with doctors annually.
Patients with breast implant complications showed up at the panel. Susan Dorsey, Mount Juliet, Tennessee, reported flu-like symptoms, neck and shoulder pain, blurry vision and a host of other problems within months of receiving silicone implants. Carolyn Wolfe, from Virginia, was found to have connective tissue disease, chronic fatigue and asthma after 28 years of having silicone implants. According to CNN, August 31, “An MRI revealed 20 lesions on her brain and two collapsed implants with very little silicone left inside.” Had Wolfe undergone MRI screening every two years as recommended by the FDA, her problems could have been averted. Silicone implants do not tear when they rupture; hence the name “silent rupture.” MRI imaging can confirm that implants are intact.
But the panel also debated MRI screening. MRI is expensive, which can be a deterrent, and some express concern about false-positive readings. The panel voted to remove MRI screening as a condition for clinical study participation, but the FDA continues to support MRI as the gold standard for detecting silent ruptures.
A consumer advocate thought that the annual 27-page questionnaire study participants were asked to complete was much too long. A monetary stipend for compliance was also suggested. Some thought patients should be paid for participating and others thought that doctors should be paid too.
The FDA is committed to seeing that the current studies are completed, ensuring that follow-up rates improve, and will look into creation of a breast implant registry, possibly on an international scale. They will continue to enlist feedback from all parties involved about amassing adequate data on silicone-gel breast implants.
The American Society for Aesthetic Plastic Surgery (ASAPS), is recognized as the world’s leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body. ASAPS is comprised of over 2,600 Plastic Surgeons; active members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and non-surgical aesthetic procedures. International active members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements.
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