Breast Implants Are Risky Enough to Need a Warning, FDA Says
With hundreds of women reporting that they developed a rare form of blood cancer, the agency wants manufacturers to warn of the dangers
The risk of developing cancer from breast implants is high enough that the Food and Drug Administration now wants women to receive explicit warnings about the dangers before they go under the knife.
The FDA said Wednesday that implant manufacturers should add a boxed warning — similar to the cautionary boxes on cigarette packaging — on all of their products with a list of all of the possible dangers.
Those dangers include rupture, scarring, pain and a rare form of blood cancer, anaplastic large cell lymphoma or BIA-ALCL. As of July 6, 573 people have reported developing the cancer, and 33 people have died.
However, it will be up to doctors to read off the warnings to their patients, who would not typically see the box before surgery. Additionally, the warnings are not yet mandatory, and the FDA is currently soliciting suggestions from manufacturers and the public on the suggested warnings before they finalize their decision.
“We have heard from many women that they are not fully informed of the risks when considering breast implants,” the FDA said in a statement.
The warnings would also include a checklist of other post-surgery risks for women to be aware of, from chronic pain, numbness and complications if they smoke or are on dialysis. The FDA also wants to warn women that some people who gave birth or breastfed after getting implants said their children developed health problems.
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They also want manufacturers to make it clear that the implants are not intended to be permanent, and around 1 in 5 women with cosmetic implants will need to get them removed after 8 to 10 years.
The FDA spent 2019 researching and holding hearings about the safety of breast implants. In July, they pushed Allergen, the makers of several types of breast implants, to recall their textured versions due to the cancer risk. Of the 573 cases of BIA-ALCL, 481 are tied to the Allergen implants, and 12 of the 33 deaths.
The FDA also said they’ve received reports from women who say their breast implants are causing other health problems, including rheumatoid arthritis, muscle pain and chronic fatigue.
Lawmakers in France, Canada and the Netherlands have all banned textured implants due to the health risks.