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Federal health officials have determined that a second silicone breast implant recall does not need to be issued due to the potential safety concerns that have surfaced recently.
FDA officials said on Thursday that a lack of long-term testing data and known silicone breast implant complications were not enough for the agency to issue another recall for silicone breast implants, which were previously removed from the market in 1992 because manufacturers had failed to provide the FDA with necessary medical data showing that the implants were safe and effective.
Silicone breast implants returned to the market in 2006, after the FDA determined that studies did not find a connection between the breast implants and cancer. However, in recent years, some experts have criticized the agency for allowing silicone breast implants back onto the market and warned women not to use them.
The FDA decision came after a two-day meeting by the FDA’s General and Plastic Surgery Devices Panel earlier this week, which met to discuss post-marketing issues with silicone breast implants.
Manufacturers have previously reported that they have problems keeping women enrolled in silicone breast implant studies, which the FDA says it needs to be able to accurately assess silicone breast implant risks and side effects.
A number of serious complications have already been linked to silicone breast implants, including implant rupture, wrinkling, asymmetrical appearance, scarring, pain and infection.
Although a silicone implant recall will not be issued, the FDA is calling on manufacturers, including Johnson & Johnson and Allergan, to find ways to improve participation by women in post-marketing silicone breast implant studies so that there will be better data on the long-term effects of the implants.
Allergan and Johnson & Johnson have previously failed in their efforts to follow-up with women who signed up to participate in studies about the long-term effects of breast implants, with Allergan only keeping up with about 60% of its subjects and Johnson & Johnson’s Mentor unit logging a dismal 21% participation of women in its post marketing surveillance studies just three years into the research. The FDA said those studies, which were supposed to track about 80,000 women who received the implants, will be useless without higher levels of participation.
The FDA has issued several warnings to consumers regarding silicone breast implant side effects. In January, the FDA also warned that both silicone and saline breast implants may be linked to a form of cancer known as anaplastic large cell lymphoma (ALCL). While it can form in the breasts, it is not considered breast cancer.
Women who are considering receiving silicone gel-filled breast implants should be aware that they are not lifetime devices and that the longer they had them, the more likely they were to suffer complications, according to the FDA.