In 2017, the FDA linked both silicone and saline breast implants to a rare form of cancer that killed at least nine people in the U.S., according to CNBC.
In addition, earlier this year FDA officials found a connection between breast implants and 457 U.S. women diagnosed with breast implant-associated anaplastic large cell lymphoma, a rare form of cancer of the immune system.
The evidence of increased cancer risk also prompted Allergan to recall textured implants in July 2019.
“We have heard from many women that they are not fully informed of the risks when considering breast implants,” the agency said. “They’ve stated that they need more information to facilitate meaningful conversations with their doctors and to make appropriate decisions for themselves.”
The new guidance Oct. 23 advises manufacturers to include warnings on their packaging and also presenting patients with a decision checklist that helps to provide them with information about the risks.
There will be a public discussion on the draft policy, before it would be adopted by the FDA.
Read the full news release here.
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