Textured Breast Implant Recall in Europe
As of Tuesday, December 18th, 2018, French regulatory officials have asked pharmaceutical company Allergan to recall their textured breast implants due to a concern over the risk of cancer. These implants make up about 85 percent of cosmetic and reconstructive implants in France.
The cancer associated with these textured implants is rare, but recent research suggests it might not be quite as rare as previously thought. The disease is not breast cancer, but rather a cancer of the immune system known as implant-associated anaplastic large-cell lymphoma (ALCL). It is not uncommon for this cancer to surface several years after the implant surgery. For those who do develop this type of cancer, it generally goes away following removal of the implant, but it can be serious and, in some cases, fatal.
For the time being, the sale of textured breast implants to consumers in France and the rest of Europe has been banned, and textured implants that are kept on hand at health centers are being actively recalled. Women who have these implants already are advised to consult a doctor, especially if they’ve experienced any of the symptoms of this or any other cancer. Symptoms may include pain, lumps, swelling, breast asymmetry, and other breast changes.
If there are no symptoms present, authorities believe there is no reason to have your implants removed, but it’s still a good idea to talk to your doctor about your risk and what to watch out for. France’s National Agency for the Safety of Medicines and Health Products (ANSM) says they have not identified “any immediate risk for the health of women carrying the implants concerned.”
In accordance with the request from France’s ANSM, Allergan has halted the sale of their textured breast implants and expanders in 33 countries where European Union health, safety, and environmental standards are required to be met. They will not be sold again until Allergan can provide the proper documentation and get its CE stamp of approval back.
“Allergan is evaluating the subsequent request from ANSM and the Company will continue to engage the French regulator on determining the appropriate next steps,” Allergan’s statement said. “Allergan stands behind the benefit/risk profile of our breast implant products. The ANSM request, and any action, is not based on any new scientific evidence regarding these products. Furthermore, ANSM has not identified any immediate risk to the health of women with textured breast implants.”
The recall does not extend to the United States, where a there have been reported cases of this cancer, including a few deaths, but where it is, on the whole, more likely for doctors to recommend smooth breast implants over textured ones. However, the majority of the 600 reported worldwide cases of ALCL have occurred in the United States, so please do not hesitate to consult a doctor if you have any of the associated symptoms.
The U.S. Food and Drug Administration will be reviewing the safety of all breast implants in 2019.