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FDA Advisory Panel Continues To Debate Silicone Breast Implant Safety Studies


A FDA advisory panel is working on devising better safety and follow-up protocol for patients who have gotten silicone breast implants.

One of the most popular cosmetic surgeries performed, year after year, breast augmentation is currently under some scrutiny as a 2-day FDA advisory panel meets to discuss follow-up safety studies for silicone breast implants in patients that were a part of a crucial decision to allow silicone breast implants back on the market in 2006.

fda questions silicone breast implants safety studies
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According to WebMD.com, the FDA released a preliminary report in June 2011 that concluded silicone breast implants were not "lifetime devices" but were largely safe and effective. They also did not find evidence that the silicone implants were linked to breast cancer or diseases as previously thought. However, in the past few days, safety studies are under review due to the loss of patients who agreed to mandatory safety follow-up protocol which was crucial to the FDA's decision to return silicone breast implants to the market.

The first patient to receive silicone breast implants was Timmie Jean Lindsey in 1962. Since the FDA didn't enact their Medical Devices Amendment until 1976, silicone breast implants were grandfathered in were not subject to trials and testing until patients began to report ruptured silicone implants and the potential dangerous health risks or diseases from silicone came to light. In January 1992, the FDA issued a voluntary moratorium on silicone breast implants - requesting manufacturers stop making them and physicians stop implanting them - while the FDA reviewed the effectiveness and safety of the implants.

In November 2006, the FDA approved the use of silicone breast implants with provisions that manufacturers were to conduct 6 post-approval studies to continue to prove silicone implants' safety and effectiveness. These post-approval studies were to monitor potential health risks including, but not limited to connective tissue diseases, cancer, interference with mammograms or problems in babies of mothers with breast implants.

The major silicone breast implant companies agreed to the FDA's provisions and enrolled over 82,000 silicone breast implant patients and 16,000 saline breast implant patients in their studies, which were to follow the women for the next decade. However, 3 years into the studies, Mentor, who manufactures Memory Gel implants has lost 79% of the patients enrolled and Allergen (maker of Natrelle silicone implants) has lost almost 40% of the women in their studies.

Representatives from silicone breast companies cited many reasons for the loss of enrolled patients, of which include the large scope and amount of patients in the initial study, time and expense necessary for multiple physician follow-ups, expensive recommended MRI scans and an annual 27-page questionnaire. Another reason patients may have fallen off the program is most people just don't return to their doctor if they feel fine.

As a result, testing of the safety of silicone breast implants may not yield conclusive data since patients cannot be found and proper monitoring of them and any potential health risks stemming from the implants are unavailable. According to Reuters.com, consumer advocate groups are asking for manufacturers to remove silicone breast implants from the market but the FDA maintains that the issue of product removal is not being discussed by the FDA advisory panel during the current 2-day review.

The FDA panel is being tasked to help find a way to fix the current model to make a better follow-up safety protocol: working with doctors, manufacturers and patients to design easier to follow post-silicone breast implant safety studies.