Allergan Global Breast Implant Recall 2019: Textured Breast Implants Recalled Over Cancer Risk
Pharmaceutical company Allergan (AGN) has issued a worldwide recall of its Biocell textured breast implants and tissue expanders because they could cause a rare form of cancer.
The recall follows the global safety advisory by the U.S. Food and Drug Administration (FDA) over breast implants that could, in some instances, cause anaplastic large cell lymphoma. Allergan voluntarily made the recall as a precaution after the FDA’s announcement.
The affected breast implants include both saline- and silicone-filled products that Allergan said will “no longer be distributed or sold in any market.” A full list of recalled breast implants recalled can be viewed here.
Allergan is urging patients to contact their plastic surgeon about the risks and benefits of their implants if they have concerns. The FDA has not recommended that these breast implants be removed or replaced in asymptomatic patients.
"It's our estimation that hundreds of thousands of women have these implants," Dr. Binita Ashar, FDA director of the office of surgical and infection control devices, said during a press conference on Wednesday. More information is expected to come from the FDA in the coming weeks, according to Ashar.
The company said that effective immediately, the Biocell implants and tissue expanders should not be used. They should be returned to Allergan.
U.S. healthcare providers that have questions about the recall can contact Medical Information at 1-800-678-1605 and select option #2, or via email at IR-Medcom@allergan.com. Other countries can contact Allergen in their country with this link.
The recall does not affect Allergan’s Natrelle smooth or Microcell breast implants and tissue expanders. The recalled breast implants and expanders represent less than 5 percent of the ones used in the U.S., CNN reported.
Shares of Allergan stock were down 0.30 percent as of 1:51 p.m. ET on Wednesday.
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