After a two-day review, the Food and Drug Administration (FDA) determined that silicone breast implants should not be removed from the market, but they do pose risks and should be removed / replaced after 10 years.
The review came after consumer groups, including the National Organization for Women Foundation and the National Research Center for Women and Families, had petitioned the agency to ban Johnson & Johnson’s silicone implants – manufactured by its subsidiary Mentor. The medical device maker was ordered to collect long-term safety data on its device; however, Mentor only collected about 21 percent of three-year follow-up data on 40,000 patients who received the implants. Allergan, another manufacturer, only collected two-year data on about 60 percent of women who received its implants.
Silicone breast implants were banned for 14 years based on safety concerns, but were allowed back on the market in 2006 under the stipulation that manufacturers collect post-marketing data.
“It is unacceptable that many patients Mentor and Allergan were supposed to track were lost,” said Jan Erickson, spokesperson for the National Organization for Women Foundation. “Mentor’s approval should be rescinded right away. And Allergan should be required to conduct further studies.”
The FDA agreed that the companies failed miserably to track the women, but the agency said it would work with both companies to help them complete their studies.
Silicone breast implants have been linked to complications including ruptures, hardening in the area surrounding the implants, scarring, pain and infections.
When concerns were raised about breast silicone breast implants in the early 1990s, manufacturers introduced saline-filled breast implants. Many women assumed these implants were safer than silicone-filled implants, but they also carry risks.
Thousands of women with saline breast implants have suffered from silicone toxicity and experienced symptoms including neurological problems, arrhythmias, burning sensations, periodontal disease, sinus and respiratory infections, bladder infections, low energy levels, muscle aches and mental clouding. Surgery to remove the implants and antibiotics are generally prescribed to relieve symptoms.
Saline breast implants have also been linked to a type of cancer called anaplastic large cell lymphoma, or ALCL.
Breast implant experts recommend that breast implants be replaced every 10 years whether or not symptoms are being experienced because eventually they will fail.