Ireland-based pharmaceutical company Allergan – one of the world’s largest manufacturers of breast implants – was recently ordered by French authorities to halt all sales of its textured breast implants over growing safety concerns that the implants could increase a woman’s risk of developing cancer.
Abbreviated as BIA-ALCL, breast implant-associated anaplastic large cell lymphoma, is a rare cancer that forms in the scar tissue capsule that surrounds the breast implant. Worldwide, more than 600 cases of BIA-ALCL have been reported, and the majority of these cases have occurred in women with rough-surfaced, or “textured” implants as opposed to smooth-surfaced implants.
While it has taken several years for the link between certain breast implants and the rare form of cancer to sharpen into view, an increase in incidences and a growing body of research has led government agencies to start taking action. In France, the National Agency of the Safety of Medicines and Health Products (NASM) chose not to renew Allergan’s CE mark on its textured breast implants, the safety certification that indicates a given product’s compliance with health and safety standards.
France’s decision not renew the company’s CE mark follows a recent recommendation by the NASM for consumers to use smooth-shell breast implants instead of those with textured-shells. As with all medical devices sold in Europe, they must have CE marks to be marketed and sold, which means Allergan cannot sell its textured implants in 33 European countries.
In a statement issued Tuesday, the company stood pat, stating, “Allergan stands behind the benefit/risk profile of our breast implant products.”
The specific line of products affected in Europe is Allergan’s Natrelle® silicone breast implants.
What Is the Status of Textured Implants in the U.S.?
The decision by France’s NASM to halt sales of Allergan textured implants does not affect the marketing or selling of the implants in the United States.
On the home front, textured implants are still an option for all women considering breast implants for either cosmetic or reconstructive purposes. While the U.S. Food and Drug Administration (FDA) is conducting more research on textured implants and plans to hold evidence-gathering public meetings this year, no such mandate for companies to halt sales of textured implants has been made.
Textured implants are more commonly used in Europe than in the United States, where smooth-surfaced implants are typically recommended by plastic surgeons. That said, most of the 600 reported incidences of BIA-ALCL have been reported in the United States. As of the most recent data, compiled in August 2018, the FDA had received 414 reports of BIA-ALCL — 9 of which were fatal. In nearly 90 percent of all detailed reports, the implant used had a textured surface as opposed to smooth.
As of now, the risk of BIA-ALCL occurring is 1 woman in every 3,817 to 30,000 women with textured implants.
Know the Risks and the Signs
For an overwhelming majority of women, including those who have survived breast cancer and are getting reconstructive surgeries, receiving breast implants is a choice. Getting cancer, however, was not.
Just as with any other medical device, it is absolutely vital to know and understand the risks, and this includes the risk for BIA-ALCL. While the cancer is exceptionally rare, it remains a risk for anyone who receives breast implants.
Though BIA-ALCL does not typically develop until 7 or 8 years have passed since initial implantation, signs of cancer can be subtle and hard to detect without further testing. Symptoms include:
- Breast asymmetry or enlargement
It’s important for women who are experiencing any symptoms associated with their breast implants to contact a doctor or medical professional right away. Early detection of any cancer, including BIA-ALCL, is key to beating it.