Allergan, known for its facial aesthetics, plastic surgery, and regenerative medicine business, has stopped selling and manufacturing textured breast implants in the European market and existing textured implants have been recalled. The French Regulatory Authority recalled the implants after requesting more information about the devices. This recall affects countries that are part of the European Union and other countries that sell products within the European Economic Area.
This comes after reports, including a recent article from The Guardian, reveal that the implants are linked to health risks. In the past, textured implants have been associated with Anaplastic Large Cell Lymphoma (BIA-ALCL). The U.S. Food and Drug Administration (FDA) states on its website that “Individuals with breast implants have a risk of developing breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.” The FDA also states that “most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.”
“Patient safety and product quality are Allergan’s highest priorities. Allergan takes this situation very seriously and is committed to engaging with all stakeholders to ensure they have the most up to date information,” says Charles Hugh-Jones, chief medical officer at Allergan. “We are committed to strict adherence to all regulatory requirements, to the most rigorous scientific evidence and to the highest industry standards for our products.”
The FDA reports that since September of 2017 there have been 414 cases of BIA-ALCL linked to medical devices. Of those cases, 272 reported the surface design of the device, and 242 had textured surfaces.
In the U.S. smooth implants are more common than the textured implants. Those with questions about their implants should speak to their doctor.
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