FDA Says Textured Breast Implants Need Stronger Warnings

USA – Wmtw.com writes that the Food and Drug Administration (FDA) released new and updated guidelines for breast implants. The recommendations are currently in the public comment and review stage and are not finalized.

Breast implants have been connected to numerous health complications, but the FDA has not previously issued such guidance on the products. Now the administration is suggesting that the device packaging for implants be marked with the “boxed warning,” which is the most serious type of warning label the FDA uses on medical devices.

The newly proposed warnings would include statements indicating that breast implants should not be considered lifetime devices, and warnings about the potential link between breast implants and a rare form of cancer called anaplastic large cell lymphoma. The FDA also recommends that physicians speak to patients about the possible risks and go through a checklist to determine whether they want to undergo the procedure.

The FDA has released statements about their proposed breast implant warnings saying that the new warnings will make it possible for patients considering breast implants to make more informed decisions. If the guidance is finalized, then companies that manufacture implants will either have to use the proposed warnings or develop their own labeling as long as the labels are in compliance with the FDA’s regulations and laws.

The proposal comes after women who suffered from complications, including cancer, testified at a public advisory panel meeting in front of the FDA to argue that they were not given sufficient information before undergoing breast implant surgery.

Additionally, Allergan recalled its Biocell textured implants last July after the implants were linked to cancer. The type of breast implant Allergan recalled is not commonly used in the United States.

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