New Breast Implant Scare In France Leads To Warnings
By Jof Enriquez,
Follow me on Twitter @jofenriq
Health authorities in France will now require breast implants to carry a warning after the implants were linked to cases of a rare form of blood cancer.
France's National Cancer Institute recently announced that it has found a "clearly established link" between a specific type of breast implant and 18 cases of anaplastic large cell lymphoma (ALCL) since 2011, according to the Daily Mail.
However, authorities believe that the cases are rare and are recommending not to remove the implants to at this time.
"We do not recommend that women carrying these implants have them removed," Health Minister Marisol Touraine said. She allayed fears among women who have received implants and advised them to not be "carried away by excessive worry."
"Our vigilance is absolute," she said, according to the Daily Mail. French officials are now requiring manufacturers to carry a warning to inform women of all the risks involved, including a potential link to cancer.
The Daily Mail found out via the Parisien Daily that 14 of the 18 cases of lymphoma were found in women with breast implants made by U.S. pharmaceutical company Allergan. However, French officials did not name a particular brand in their announcement.
According to the Daily Mail, Allergan issued a recent statement saying that, "The security of patients is our first priority." The company said it is cooperating with France's drug regulatory agency, the National Security Agency for Medicines and Health Products (ANSM), on the reported links of their implants to lymphoma.
ALCL is a rare type of cancer characterized by white blood cells growing out of control. Lymphocytes ‐ a type of white blood cell — accumulate in the lymph nodes, skin, and lungs. Symptoms include swelling of the lymph nodes, fatigue, and weight loss. Chemotherapy and radiotherapy are standard treatments.
According to an FDA analysis, "Although ALCL is extremely rare, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant."
It is not the first time breast implants have been implicated in public health scares in France. In 2011, breast implants manufactured by French company Poly Implant Prothèse (PIP) were found to have an unusually high rate of ruptures. Almost 50,000 women in the UK and some 400,000 worldwide, were affected by the PIP scandal, according to the Daily Mail.
Subsequent official investigations concluded that there was no evidence that the implants were toxic or carcinogenic, and they were not recommended to be removed, according to the report. However, the company later closed and its founder was jailed.
The PIP scandal prompted the European Commission to adopt more stringent measures to improve the safety of medical devices. One rule laid out new criteria notified bodies must meet to operate in the European Union, while the other describes the tasks they must perform when they audit and assess device facilities, according to a previous Med Device Online article.