FDA orders recall of breast implants for women with risk of bleeding, infections

The Food and Drug Administration announced Thursday that the agency is requiring all female breast implant patients to have their implants recalled if they have a history of bleeding, infection or developing into fat…

FDA orders recall of breast implants for women with risk of bleeding, infections

The Food and Drug Administration announced Thursday that the agency is requiring all female breast implant patients to have their implants recalled if they have a history of bleeding, infection or developing into fat and other tissue over time.

The agency also stated that it is requiring manufacturers to include stronger warnings for women with “significant anatomic changes” within three years of implantation.

The changes come in the wake of a series of reported incidents associated with breast implants. In 2011, 11 women sued Johnson & Johnson over a rupture of their implants, claiming that the company failed to warn them of dangers associated with implants. Four years later, in 2016, a study in the journal BMJ found “a high prevalence of adverse events … related to breast implant surgeries … an emerging allergy syndrome, polymicrobial contamination, antimicrobial resistance, and inflammatory infection” in women who received implants.

Additionally, The New York Times reported in 2015 that at least 3 million women in the United States may have had breast implants, though it is not known exactly how many have had them removed. According to the FDA’s announcement, more than one in 20 women will experience problems with implants that ultimately lead to difficulty with breastfeeding or nipple discharge or are problems linked to infection, bleeding, inflammation, scarring, pain, numbness or swelling.

The FDA also announced Thursday that it will be requiring new labeling for inserts and implants with multiple levels of metal. Typically, patients will have a single level of metal, known as a grade one or grade two, with only one injection, while a grade three implant can require multiple injections, and one with a grade four implant can require eight injections.

The FDA said it is also requiring manufacturers to inform women of the “one injection, two injections” policy and to warn patients that a “weak layer of epidermal cell migrations, different blood coagulation factors, increased levels of self-destruction [infections] can develop over time.”

On Tuesday, the FDA announced it was temporarily withdrawing all data from the Women’s Health Initiative, a clinical trial conducted in the 1990s that has data on the safety of saline breast implants. According to the FDA, it wanted to focus on its review of subgroups within the Women’s Health Initiative before it could make any safety determination. The Women’s Health Initiative involves participants from across the country who were randomized into three groups, one of which was receiving saline, one of which was undergoing silicone implants and one of which was receiving nothing at all.

The FDA said it is currently working to restart the Women’s Health Initiative and evaluate and rank the subgroups. It is looking for the best practices from other sites and research that other countries are doing.

The FDA said that since the Women’s Health Initiative was conducted in the late 1990s, new substances that have been linked to concerns have been released and many women and their doctors have not been informed about the potential risks of implants. The FDA said women often call to learn whether they are among the women involved in the Women’s Health Initiative.

“This is a vital step that will help improve the FDA’s understanding of the risk assessment for breast implants and will help move us forward on the critical path to protecting women,” the FDA’s director of the division of medical devices, Katherine Posada, said in a statement.

The announcement followed a report from the advocacy group Allergan that said the FDA wants to place additional labeling requirements on anesthetic procedures. The company’s chief executive, Brent Saunders, said such changes would be “substantively unworkable.”

“As a result, we may need to remove certain products from the U.S. market,” the company’s report stated.

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