Allergan is recalling textured breast implants in Europe, amid concerns that such devices might cause a rare form of cancer called anaplastic large-cell lymphoma.
The Allergan breast implant recall was announced after the company’s CE expired on Sunday. A CE is basically the license required to market medical devices in the European Union.
According to The New York Times, Allergan did apply to renew its breast implant CE. However, French officials requested additional data on the textured implants, which the company was unable to supply ahead of the expiration date.
For now, the rough-surfaced breast implants can’t be sold or used in the European Union. Allergan also directed European healthcare facilities to return any unused devices in their possession.
Regulators have not advised patients with textured implants to have them removed. Allergan will also continue to sell smooth-surface breast implants in the European Union.
In a statement, the company said it would continue working with French regulators “on determining the appropriate next steps.” France will convene a hearing in February to investigate the risk of breast implant-associate anaplastic large-cell lymphoma, or ALCL
ALCL is not breast cancer, but is instead a rare form of non-Hodgkin’s lymphoma reported in breast augmentation patients.
The U.S. Food & Drug Administration (FDA) published its first alert for breast implant ALCL in 2011.
Just last year, the agency reported that at least 359 women had developed the cancer in the cells around their breast implants, nine of whom died. In 200 of those cases, the patients received textured implants, while the remaining patients had smooth-surface devices. At least 186 had implants filled with saline gel, while 126 patients had saline-filled devices.
At the time, the FDA estimated that breast implant cancer could affect about in 1 in 300,000 women with the devices.
In an update published last March, the agency said it was aware of 414 reports of breast implant lymphoma. Half of the reported cases occurred 7-to-8 years after implantation.
“Additionally, studies reported in medical literature estimate that the lifetime risk of developing BIA-ALCL for patients with textured breast implants ranges from 1 in 3,817 to 1 in 30,000,” the FDA warned.
Allergan continues to insist that its textured devices are safe, despite the European breast implant recall. The action does not extend to the United States, where the company’s textured breast implants remain available.
According to the FDA, breast implant-associated ALCL has generally been identified in patients with late-onset symptoms, including:
The agency does not recommend prophylactic breast implant removal for asymptomatic patients. Women with any type of breast implant should continue with their normal follow-up care and contact their doctor if they notice any changes in the look or feel of their breast once they’ve recovered from implant surgery.
Patients considering breast augmentation should discuss the risks and benefits of textured and smooth implants with their doctor.