FDA Recommends Black Box Warning For Breast Implants To ‘Improve Patient Communication’

Dr. Brad Jacobs holds up a silicone implant gel (L) and a saline implant gel (R) inside of his office November 21, 2006 in New York City. The federal government approved silicone implants last week after they were banned by the government for 14 years following concerns that the implants were not safe. Averages of 300,000 women in the United States have their breasts surgically enlarged each year.
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The United States Food and Drug Administration, commonly known as the FDA, issued a proposal on Wednesday that would require the manufacturers of breast implants to clearly reveal all the possible health risks that could occur regarding the devices. The FDA had recently received heavy criticism by women who were victims of the side effects of the implants, ranging from rare cancers to other symptoms that created the need for additional corrective surgeries.

The proposal recommended that the implant manufacturers should institute a black box warning that would make it completely clear what the risks are from the installation of the devices. Among the specific warnings, the FDA recommended consumers should be made aware that the implants are not meant to last for a lifetime and that issues regarding them could arise well after the initial surgery. A black box warning is the strictest possible warning by FDA standards.

Other risks that could be caused by breast implants include a rare form of lymphoma as well as fatigue, muscle aches, and joint pain experienced by some who have undergone the surgery. The FDA also recommended that a checklist should be created for potential patients so they can have a thorough conversation with their surgeon about the potential risks before making their deposit for the surgery.

In a statement announcing the recommendation, FDA Principal Deputy Commissioner Amy Abernethy and Jeff Shuren, director of the agency’s Center for Devices and Radiological Health said, “We have heard from many women that they are not fully informed of the risks when considering breast implants,” going on to add that the recommendations are “designed to help inform conversations between patients and health care professionals when breast implants are being considered.”

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Breast implants are used in 400,000 surgeries in the United States every year, with 75 percent of the women involved getting implants for cosmetic reasons. The rise of social media has seen those who have dealt with harmful side effects from the implants to become more vocal of the risk, with tens of thousands of women suffering from complications. That combined with the reveal of rare cancer linked to the implants has forced the FDA to put pressure on manufacturers.

The cancer is known as anaplastic large cell lymphoma, a cancer of the immune system. Since they began tracking the cancer in 2011, the FDA has seen 573 cases with the majority linked to the now-recalled Allergan textured implants. The disease has so far killed 33 women.