French health regulators are calling for a ban of Allergan’s textured breast implants, and cautioning doctors and patients about texture implants from other manufacturers. The implants are associated with an increased risk for a type of non-Hodgkin lymphoma called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Textured implants makeup about 85 percent of the implants used for cosmetic and reconstructive breast surgeries in France.
The National Agency for Safety of Medicines and Health Products (ANSM) recommendation comes after two days of testimony during a public hearing about the safety concerns with the breast implants, and days after the U.S. Food and Drug Administration (FDA) notified consumers that it had received more reports of BIA-ALCL, bringing the total to 457, nine of whom have died.
ANSM recalled Allergan’s textured implants in December amid rising concerns about the implant following an NBC News investigation that found BIA-ALCL is more common than originally thought.
In February, the FDA issued a letter to health care providers to raise their awareness about the association between all breast implants – regardless of filling or texture – and BIA-ALCL. The disease typically develops within the scar capsule adjacent to the implant. Doctors were asked to be aware that BIA-ALCL may be present in women with breast implants that present with symptoms such as new swelling, lumps, or pain around the breast implants.
The FDA said it was continuing to evaluate all available information to understand the nature and possible factors contributing to the disease in patients with breast implants.