As a precaution, Allergan (NYSE:AGN) is voluntarily recalling its BIOCELL textured breast implants and tissue expanders worldwide in response to global safety information about the rare risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
Effective immediately, healthcare providers should not implant the products. Distribution and sales will also cease.
Global regulators, including the FDA, have not recommended the removal or replacement of the products in asymptomatic patients.
The company says the recall does not affect its NATRELLE smooth or MICROCELL breast implants and tissue expanders.
Update: In a statement, the FDA indicated that it requested the recall of specific models of textured implants from the U.S. market due to the cancer risk. To date, there have been 573 cases of BIA-ALCL, including 33 deaths, reported globally. 481 of the cases are attributed to Allergan implants, including 12 deaths. The agency says its analysis showed that the risk of BIA-ALCL is six times greater with Allergan’s BIOCELL compared to other manufacturers. The FDA is considering additional actions including updated labeling, which could include a boxed warning, and a decision checklist to help patients assess the benefits and risks of receiving a breast implant.
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