FDA

FDA Asks Allergan to Recall Certain Textured Breast Implants

By MedTech Intelligence Staff
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FDA

After prompting from the agency, Allergan issued a worldwide recall of its BIOCELL textured breast implants and tissue expanders.

As FDA continues to address the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) related to textured breast implants, the agency asked Allergan to recall certain models of these implants. Allergan responded by initiating a worldwide recall of its BIOCELL textured breast implants, which includes its Natrelle saline-filled and silicone-filled implants, Natrelle Inspira silicone-filled implants and Natrelle 410 highly cohesive anatomically shaped silicone-filled implants. In addition, the recall includes tissue expanders that were used in patients before breast augmentation or reconstruction.

“Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. in an agency news release. The FDA initially discovered the potential link between breast implants and ALCL in 2011 and has been monitoring the issue since then.

“We understand that today’s news may be alarming to some patients with breast implants,” said CDRH Director Jeff Shuren, M.D. “We are continuing our assessment to determine whether the risk of developing BIA-ALCL is limited to specific models of textured, or all textured breast implants. We continue to advise women and health care professionals that the use of breast implants is associated with a risk of developing BIA-ALCL and that the risk is greater with textured implants.”

Due to possible risks, the FDA is not recommending implant removal for patients who do not have symptoms.

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