FDA Warns of Cancer Linked to Certain Breast Implants

  • FDA Warns of Cancer Linked to Certain Breast Implants

FDA Warns of Cancer Linked to Certain Breast Implants

More women have been diagnosed with a deadly lymphoma caused by breast implants, according to a report released Wednesday from the Food and Drug Administration.

The agency says more than 450 women in the USA have been diagnosed with anaplastic large cell lymphoma.

While the FDA's medical device reporting system allows patients, providers and manufacturers to each file their own reports, even if it's about the same case, not every report captures thorough information-such as the type of breast implant, reasons for use and characteristics such as surface texture.

Nine of them have died. The updated data comes weeks before a March FDA advisory committee meeting is set to examine known breast implant risks, with particular focus on capsular contracture and implant rupture in addition to the lymphoma.

Women with breast implants have an increased risk of developing anaplastic large cell lymphoma, the FDA has said, compared to women who don't have breast implants.

'We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL, ' Dr. Ashar said in the statement.

'We want all healthcare providers to be aware. particularly in patients with new swelling, lumps, or pain around breast implants, to expedite diagnosis of this malignancy, ' the letter said, according to CNN.

The American Society for Aesthetic Plastic Surgery and the American Society of Plastic Surgeons has written: "BIA-ALCL usually develops as a delayed swelling of the breast (Average 8 years, range 2 to 28 years) after the insertion of textured breast implants, which may present as fluid collecting around the implant or marked breast asymmetry".

'When breast implants are placed in the body, they are inserted behind the breast tissue or under the chest muscle. Textured implants have been shown to more frequently associated with the disease than those that are smooth, though the surface type of implants is not always reported at time of diagnosis. "Textured breast implants tend to stick to the body's tissue, helping them stay in the same position over time". There have been more than 600 cases of BIA-ALCL, a cancer of the immune system, reported worldwide.

A large manufacturer of breast implants, Allergan, suffered internationally in December when France issued a mandatory recall of textured breast implants, and shortly thereafter Allergan lost its CE mark.

However, the majority of ALCL cases have been linked to the textured devices.