FDA issues safety alert on breast implant-associated cancers

by time news

The US health authorities (FDA, for its acronym in English) have issued a new alert to those women who have a type of breast implants or who are considering putting them in that certain types of cancer can develop in the scar tissue that forms around the implants.

Malignant tumors are rare but have been linked to implants of all types, including those with surfaces textured and smooth, and those that are filled with saline or silicone.

The FDA confirmed that link more than a decade ago on textured implants, in realization of the increase in a rare cancer called anaplastic cell lymphoma. The new warning is about another cancer, squamous cell carcinoma, as well as other types of lymphoma that may be related to implants.

The implants are called macrotexturized, those in which the surface that covers the silicone is rough or they are covered by a polyurethane material.

There are few documented cases. The FDA said it was aware of fewer than 20 cases of carcinoma and fewer than 30 cases of unexpected lymphomas in the capsule around the implant.

In this new warning, the agency reminds us that breast implants do not last a lifetime. The agency does not put an expiration date on the prostheses, but recalls the need to periodically review the implants to monitor their good condition.

In December 2018, the Spanish Agency for Medicines and Health Products (AEMPS) notified the company that distributes Biocell® textured breast implants in Spain to cease marketing them and proceed to withdraw them from the market as they did not have the CE marking certificate in vigor.

In July 2019, the manufacturing company, Allergan, had to withdraw the implants from the Spanish market, as a precautionary measure, given the possible association of this type of prosthesis with a rough texture with the appearance of a very rare type of lymphatic cancer known as anaplastic large cell lymphoma.

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