Breast implants made by Allergan that have been linked to an uncommon form of cancer are being taken off the market in Europe, The New York Times reports French authorities announced. The implants, which have a textured or slightly roughened surface, rather than a smooth covering, cannot be manufactured or sold in Europe for the time being, and the ones kept on hand at health centres are being recalled.
According to the report, France’s National Agency for the Safety of Medicines and Health Products said it had not “identified any immediate risk for the health of women carrying the implants concerned,” and it did not mention the unusual cancer. But the products, particularly the textured ones, have been linked to a disease called breast implant-associated anaplastic large-cell lymphoma. The lymphoma is not breast cancer, but is a malignancy of the immune system that develops years after the implant surgery, often seven or eight years later. Removing the implant usually gets rid of the disease. But in some cases, the cancer spread and women died.
The report says the French action affects members of the EU as well as other countries in Europe that require a stamp of approval called a CE marking for medical devices.
The ruling does not affect the marketing of implants in the US. The report says textured implants are used more commonly in Europe than in the US, where smooth ones are more often recommended.
Allergan’s permission to market its smooth implants has been renewed, and those remain available in Europe.
The company is quoted in the report as saying, “Allergan stands behind the benefit/risk profile of our breast implant products.” It also said the recall was “not based on any new scientific evidence regarding these products.” The company said it would continue working with French regulators “on determining the appropriate next steps.”
In a notice posted on its website in August 2018, the US Food and Drug Administration said that as of 30 September, 2017, it had received 414 reports of the lymphoma, including nine cases that were fatal. The implant surface was known in only 272 of those cases, and in 242 of those it was textured. The FDA also noted that the real number of cases and size of the risk was not known, because there was a lack of information about how many women in the US and worldwide had received implants. The best estimate is that the lymphoma may occur in one in 3,817 to 30,000 women with textured implants.
Symptoms include pain, lumps, swelling or breast asymmetry, and women with implants are advised to consult a doctor if those problems occur. If there are no symptoms, there is no reason to remove the implants. The report says all women who have implants are advised to have regular check-ups as advised by their doctors.
[link url="https://www.nytimes.com/2018/12/18/health/allergan-breast-implant-cancer.html?emc=edit_th_181219&nl=todaysheadlines&nlid=425053801219"]The New York Times report[/link]