Following Allergan’s recall of textured breast implants in July due to the risk of a rare cancer called breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL) and additional related controversies, the FDA is recommending another layer of protection surrounding breast implants. The latest proposition to manufacturers, issued today: a boxed warning to be printed on the packaging of all saline and silicone gel-filled implants.
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The warning, which is the strongest level of caution required by the FDA, should explain the risks associated with breast implants and use language such as “the chance of developing complications increases over time” and “some complications will require more surgery” in order to ensure customers are fully informed of potential complications.
Another item on the list of proposed guidelines: a “patient decision checklist,” which would detail possible risks associated with breast implants. It would be provided to prospective patients to review before scheduling their surgery with their doctor.
Doctors will be responsible for reviewing this checklist with their patients; initials and/or signatures would be required to ensure both patients and physicians have affirmatively acknowledged the information discussed.
The FDA is also suggesting an exact ingredient list to be printed on breast-implant packaging to make consumers aware of the chemicals used in such devices, along with the implementation of new screening guidelines for women with existing silicone implants. These guidelines would recommend that patients undergo rupture scans every five to six years following breast implant surgery and every two to three years after that.
These recommendations, according to a statement made by the FDA, “are being made based on concerns that some patients are not receiving and/or understanding information regarding the benefits and risks of these devices.”
It’s important to note that these guidelines are suggestions to the industry—they are not mandated as of press time. However, the FDA is hoping to finalize (mandate) the guidelines shortly after a 60-day industry and public review. This post will be updated as more information becomes available.
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