Allergan said it has issued a worldwide recall of "Biocell" textured breast implants and tissue expanders, which are linked to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare cancer.
|Allergan's Natrelle 410 breast implant|
"Biocell saline-filled and silicone-filled textured breast implants and tissue expanders will no longer be distributed or sold in any market where they are currently available," the company said Wednesday. "Effective immediately, healthcare providers should no longer implant new Biocell textured breast implants and tissue expanders, and unused products should be returned to Allergan."
The move comes after the U.S. Food and Drug Administration requested Allergan to recall its products on the same day.
"The risk of BIA-ALCL with Allergan's Biocell textured implants is six times higher than those with other textured implants," the FDA said. "Continued distribution of Allergan's Biocell implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL."
According to an Allergan-FDA clinical report, 481, or 83.9 percent, out of 573 patients with BIA-ALCL have been using Allergan's implant.
The recalled Biocell textured breast implant product include Natrelle saline-filled breast implants, Natrelle silicone-filled breast implants, Natrelle Inspira silicone-filled breast implants, and Natrelle 410 highly cohesive anatomically shaped silicone-filled breast implants.
Following the U.S. drug regulator's request, the Ministry of Food and Drug Safety here also announced that Allergan submitted plans to recall its breast implants and tissue expanders, on Monday.
"Since the FDA's announcement, Allergan has voluntarily reported a specific recall plan to the ministry regarding its breast implant products," a ministry official said. "The recall procedure will start on Monday, and the ministry plans to finish the recall procedure by Aug. 28."
Korea has imported about 29,000 artificial breasts and related products made by Allergan.
"There have been no reported cases of adverse lymphomatous side effects due to the implants," the official said. "Even if the implants are planted, they do not necessarily have to be removed if they do not show any adverse effects."
However, if a patient's chest gets bigger or painful, they should seek medical advice immediately, he added.
The ministry is also considering whether to recall other textured breast implants asides from Allergan's products.
"We have asked five other companies that distribute textured breast implants to submit safety data," the official said. "After reviewing the data, we will prepare additional safety measures."