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Be Warned: FDA Recommends Tougher Labeling For Breast Implants


The FDA has recommended including a boxed warning in breast implant labeling as part of the regulatory agency's continued effort in protecting the health of women who are considering breast implants.

It is proposed that manufacturers of breast implants should include the following information in their product's label

-- that breast implants are not lifetime devices
-- that the chances of developing complications increase the longer a patient has the implant and additional surgery may be required to address the complications
-- and that breast implants have been associated with the risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and may be associated with systemic symptoms (like fatigue or joint pain).

The FDA has also recommended that the manufacturers include a patient decision checklist at the end of a patient informational booklet or brochure. A patient decision checklist can be used to help guide discussion during a patient's consultation with a surgeon.

Another recommendation put forth by the FDA is the magnetic resonance imaging (MRI) screenings for patients beginning three years following implantation and every other year thereafter.

Breast augmentation has been the top cosmetic surgical procedure since 2006, and about 313,000 breast augmentation procedures were performed in 2018, an increase of 4% over 2017, according to the American Society of Plastic Surgeons.

There are several types of breast implants - Saline breast implants, Structured saline breast implants, Silicone breast implants, Gummy bear breast implants, Round breast implants, Smooth breast implants, and Textured breast implants.

The risk of BIA-ALCL is higher for textured surface implants versus smooth surface implants, according to the FDA.

As of July 6, 2019, a total of 573 cases of breast implant-associated anaplastic large cell lymphoma and 33 patient deaths due to that cancer have been reported worldwide. Of the 573 cases, 481 are attributed to Allergan implants, and of the 33 patient deaths, 12 are confirmed to have an Allergan breast implant at the time of their BIA-ALCL diagnosis, according to the FDA.

Following reports of breast implant-associated anaplastic large cell lymphoma, Allergan recalled its BIOCELL textured breast implants and tissue expanders from the market worldwide in July of this year.

France and Canada banned the sale of certain textured breast implants in April 2019. In Australia, the suspension of certain textured breast implants comes into effect from October 25, 2019.

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