France has banned several types of textured breast implants that have been linked to a rare form of cancer, and more countries appear to be following suit, including Canada and the Netherlands.
For years researchers have raised concern about the potential association between breast implants and anaplastic large cell lymphoma (ALCL), a very rare form of cancer, but France is the first country to ban the devices. The ban took effect on Friday and covers macro-textured implants and implants with a polyurethane coating. The National Agency for Safety of Medicines and Health Products (ANSM) in France notified manufacturers of the ban last week.
The ANSM said it has not found a causal link between ALCL and the textured breast implants, but it is imposing the ban nonetheless as a « precautionary measure. » Since 2011, 59 cases have been reported in France, and most women affected by the disease had textured breast implants.
That’s about the time U.S. regulators also became concerned about the safety of these devices. In January 2011, FDA said there had been roughly 60 cases of ALCL cases in patients with breast implants. The agency said at the time that patients may have a slightly increased risk of developing the disease in a scar capsule next to the breast implant.
As MD+DI reported last year, there was a study published in the Annals of Surgery linking silicone breast implants with a handful of rare diseases. An FDA expert pointed to flaws in that particular study but acknowledged the need for better postmarket evidence generation. The authors of the study analyzed nearly 100,000 breast implant procedures gleaned from FDA-mandated postmarket studies for implants made by Mentor, a unit of Johnson & Johnson, and Allergan. According to their analysis, silicone implants are associated with higher rates of Sjögren syndrome, scleroderma, rheumatoid arthritis, stillbirth, and melanoma…