French health regulators have officially suspended their approval of the use of textured breast implants. The move means that the implants, which differ from the smooth-surfaced implants more widely used throughout the United States, are effectively no longer available anywhere in Europe.
Textured breast implants have been implicated as a possible cause of a specific type of lymphoma. The disease, formally known as breast implant-associated anaplastic large-cell lymphoma, is thought to occur when the texturing of the implant has caused sufficient damage to the tissues that surround it to start changing the cellular structure of those tissues. As a general rule, that’s about a nine-year timeframe. If caught early enough, however, the condition is largely treatable and curable.
Textured breast implants were brought to market a bit over two decades ago. The additional textures were meant as a way to mitigate against the movement of certain implants once they were put in place as well as to reduce the amount of breast hardening that can occur after implantation or augmentation surgery.
The implants were widely adopted throughout Europe while doctors and surgeons in the United States largely stayed with the smooth-surfaced implants they had already been using. Data shows that the US only accounted for 13 percent of Allergan’s textured breast implant sales. French sales, however, accounted for 85 percent of the company’s market.
The US FDA made its first mention of a possible link between the textured implants and lymphoma in 2011. At the time, the risk was thought to be less than one in 500,000. More recent research, however, puts that risk at closer to one in 2,200. For the most part, it appears that the US medical community never saw enough of a benefit to the implants to warrant the additional risk. “No one can prove any benefits to texturing,” says one surgeon. “If you remove the products, the risk goes to zero. To me, it’s a no-brainer. Personally, I think they shouldn’t be on the market.”
Apparently, neither do French regulators. And, as a result, the implants are now a thing of the past throughout all of Europe.