A further 448 have been diagnosed with anaplastic large cell lymphoma (BIA-ALCL) which forms in the scar capsule around the implant, the US Food and Drug Administration's Dr Binita Ashar said Wednesday.
As of September 2018, the FDA has received 660 adverse event reports regarding cases in the US, linked to 457 unique cases of the disease and nine patient deaths, the agency said.
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. The cancer has been linked to textured breast implants and it affects cells in the immune system. 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.
Most of the cancer cases occurred in people who had textured surfaces on their implants, rather than smooth surfaces.
"Given the agency's continued efforts to communicate with stakeholders about BIA-ALCL risks and our work to encourage patients and providers to file MDRs with the agency, these types of increases in the MDRs are to be expected and may include past cases that were not previously reported to the FDA", Ashar wrote. The products, particularly the textured variety, have over time been associated with varying certainty to autoimmune and connective tissue diseases, reproductive problems and breast and skin cancers. When breast implants are placed in the body, they are inserted behind the breast tissue or under the chest muscle. Today it made an announcement that they are sending letters to doctors, primary care physicians and gynecologists indicating to dig in more on ACLC so they can perform the diagnosis and treatment well to those who are affected.
Those who already have implants should look out for new swelling, lumps, or pain around them.
'In patients with breast implants, reported cases of BIA-ALCL were generally found adjacent to the implant itself and contained within the fibrous capsule'.
The Daily Mail notes, 'The amount of women diagnosed with BIA-ALCL - which kills cells in the immune system and normally begins with pain and swelling in the breast - shot up from 414 cases in the last 12 months and 359 the year before that ... The majority of ALCL cases have been linked to textured breast implants as opposed to smooth implants.