A company is enacting a worldwide recall of their textured breast implants due to their link to a rare cancer.
Allergen, a pharmaceutical company and the makers of several types of breast implants, initiated the global recall at the request of the U.S. Food and Drug Administration as reports continue to come in from women who have developed anaplastic large cell lymphoma, likely from the implants.
Allergen said they are recalling BIOCELL textured breast implants and tissue expanders from all markets. The products are already banned in several countries, but the FDA had declined to restrict sales in the U.S. until now, where they are far less popular, accounting for less than 5 percent of all implants sold.
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The FDA said that there have been 573 cases of the cancer, shortened to BIA-ALCL, with 33 deaths this year worldwide, a significant increase over the last year. Of those 573 cases, 481 are due to the Allergen implants, and of the 33 deaths, 12 were known to have Allergen implants.
The cancer can be cured if it’s caught early by removing the implant and the scar tissue around it, but it can require chemotherapy or additional serious treatments.
However, the FDA said that women with the Allergen implants and no symptoms do not need to have them removed — the recall is to remove them from shelves and to stop doctors from implanting them in any new patients. Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said that they do not recommend that women remove their implants if they do not have symptoms because of “potential risks.”
“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.
Abernethy said that they have been monitoring the issue since 2011, but did not feel the need to act until now, when, “based on new data, our team concluded that action is necessary at this time to protect the public health.”
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