Breast Implants to Get New Black Box Warning

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FDA Wants Stronger Warnings On Breast Implants Over Cancer Risks

In the wake of the Allergan breast implant recall last summer, the U.S. Food and Drug Administration is recommending a new black box warning due to the devices’ risks of cancer. 

The agency issued a draft guidance on Oct. 24, 2019 recommending manufacturers add a “black box warning” to breast implant labeling. 

Black box warnings are the FDA’s strictest warnings, and alert patients and healthcare providers to potential dangers associated with the products. 

The recommendation comes after Allergan pulled its textured breast implants from the global market in July 2019 over risks of a rare form of cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). 

Textured implants manufactured by Allergan were associated with the vast majority of BIA-ALCL cases. The textured surface of the implant may put women at increased risk of cancer as compared to other kinds of implants. This type of surface is unique to Allergan implants, and the risk of BIA-ALCL is 6 times that of other implants.

Because of this, the FDA wants all breast implant manufacturers add boxed warnings to their products’ labels.

The agency recommends manufacturers add warnings that include the following information:

  • Breast implants are not considered lifetime devices 
  • The chance of developing complications increases over time
  • Some complications will require more surgery
  • Breast implants have been associated with the risk of developing BIA-ALCL and may be associated with systemic symptoms

The draft guidance is open for comments from the public until Dec. 23, 2019 before it is finalized and added to the products’ labeling. 

In addition to a black box warning, the FDA is also recommending manufacturers include a patient decision checklist with the device labeling. The checklist would include information about the potential risks of breast implants that is easily digestible so patients can make informed decisions about whether or not to have the devices implanted.