France Bans all Textured and Polyurethane Breast Implants Amid BIA-ALCL Cancer Scare
Breast implants have been a highly debated topic in the last several months, as an increasing number of cases of a rare cancer have been found in women with breast implants, most often textured ones. There have been upwards of 600 cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) worldwide and at least 457 cases in the U.S. alone. At least 16 women worldwide have died of the disease, nine of which were in the U.S.
In November of 2018, when the Implant Files Investigation led by the International Consortium of Investigative Journalists was published and brought many of these cases to light, it sparked a global concern about the safety of breast implants. Since then, French regulatory officials asked breast implant manufacturer Allergan to recall its textured implants in the 33 countries where it sold them. At the time, Allergan’s textured implants made up 85 percent of the French breast implant market.
Now the country is taking an even larger step for women’s safety—banning all textured and polyurethane breast implants.
Six manufacturers, namely Allergan (for its Biocell implants), Arion, Sebbin, Nagor, Eurosilicone, and Polytech, are targeted by the ban and will no longer be able to sell their macro-textured and polyurethane breast implant products in France, starting April 5th, 2019.
BIA-ALCL is a rare type of cancer of the immune system which originates and causes symptoms in the tissue area surrounding the breast implant. Of the roughly 500,000 women in France who have gotten breast implants, only 59 women have developed the disease, and just three women have died of BIA-ALCL.
Because the risk of developing BIA-ALCL is very low, it’s important to note that France is only banning the sale and insertion of these implants from here on out as a precautionary measure. Officials are not suggesting that women who already have these implants get them removed.
However, women who are experiencing any of the symptoms of BIA-ALCL should see a doctor about it and potentially have their implants removed. Symptoms may include pain, lumps, swelling, breast asymmetry, and other breast changes.
So far, the United States does not appear to be getting any closer to banning textured implants or requiring a recall of any such products. The prevalence of textured implants in the states is much lower than in some other countries, at just 13 percent of breast implants.
“Many studies have looked to estimate risk and, depending on the source data and country, the global lifetime risk of developing breast-implant-associated ALCL for patients with textured breast implants ranges anywhere from 1 in 3,817 to 1 in 30,000,” the FDA said. The organization also recently sent out letters to primary care physicians encouraging them to become more educated on BIA-ALCL and talk to their patients about it.
However, you should still consider consulting your doctor if you have any type of breast implant and are exhibiting one or more of the symptoms of BIA-ALCL. Although the cancer is very rare, even in those with textured implants, it can develop in women with smooth implants as well.
Luckily, BIA-ALCL is highly treatable. In most cases, simply removing the implants and the surrounding pocket of scar tissue where the cancer resides will cause the issue to clear up on its own. Only in very few cases has the cancer gone undetected long enough to become deadly.
Will the U.S. be the next country to ban textured implants? Only time will tell.