FDA Now Wants Breast Implant Manufacturers to Warn People of Potential Risks

FDA Now Wants Breast Implant Manufacturers to Warn People of Potential Risks
Image:Associated Press

After years of advising that it’s largely safe to get breast implants, the Food and Drug Administration is now recommending that breast implants come with stronger warnings about their possible health risks, ranging from fatigue to a rare form of cancer associated with a specific type of textured implant.

On Wednesday, FDA officials released a guidance proposing that implant manufacturers include a boxed warning, which the Associated Press noted is the “most serious type of warning,” on their breast implants, as well as a checklist that spells out the potential risks and complications.

In March, dozens of women testified before the FDA that they had suffered from autoimmune diseases or even anaplastic large-cell lymphoma, a rare form of lymphoma associated with some breast implants, and called on the agency to better protect consumers. While the proposed changes don’t go as far as to ban the breast implants linked to a higher risk of developing anaplastic large-cell lymphoma, they incorporate some of the requests made at that March meeting, and echo the demands of an online petition that has been signed by more than 70,000 people.

“We’ve heard loud and clear from the public advisory panel meeting we held earlier this year and from the information we’ve gathered from other ongoing efforts to engage with patients and stakeholders that there is a distinct opportunity to do more to protect women who are considering breast implants,” the FDA wrote in a press release. The agency added, “We have heard from many women that they are not fully informed of the risks when considering breast implants.”

The boxed warning, if implemented by manufacturers, would inform patients that “breast implants are not considered lifetime devices,” that the “chance of developing complications increases over time” and may require additional surgery, as well as the link between anaplastic large-cell lymphoma and textured breast implants.

The proposed checklist would include more details of potential risks. Per the New York Times:

The checklist would go into even greater detail, warning women that if they smoke or have medical conditions like diabetes or autoimmune disease, they may not fare well after surgery.
All women may be left with chronic pain, loss of sensation or asymmetrical breasts, among other complications, the agency said. The proposed checklist would also warn that some women who had babies or breastfed after getting breast implants had reported health problems in their children.
The proposed checklist also would say that more than half of patients experience adverse events like a painful tightening of scar tissue around the implant.

Still, the proposal is fairly weak—these are merely proposed changes at this point, and if they go into effect, they would not be mandatory. And, as the Times points out, “since patients rarely see a medical device before a procedure, it will be up to plastic surgeons to make sure women are fully informed of both the risks and benefits.”

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