FDA reports additional cases of cancer linked to breast implants
10 Février, 2019, 17:14 | Auteur: Yves Courtet
A deadly cancer linked to breast implants has been found in additional women in the United States, federal health officials said.
So far, 457 women in the US have been diagnosed with anaplastic large cell lymphoma tied to breast implants.
After discussing the risk with French authorities, the FDA moved forward with its own warning on cancer risk from breast implants.
In conjunction with Ashar's statement, CDRH's chief medical officer William Maisel sent a letter to healthcare providers updating them with FDA's latest analysis. Aside from informing physicians and doctors, the FDA should also meet to review the safety regulations of all breast implants.
The textured implants have become increasingly popular because women don't have to worry about getting the implant re-positioned.
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.
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"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.
"I know there are many choices of breast implants available to patients, including the size, implant fill and surface texture", Binita Ashar, who runs the Center for Devices and Radiological Health at the Food and Drug Administration, said in a news release.
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". Despite being associated with implants, ALCL is not breast cancer. "Textured breast implants tend to stick to the body's tissue, helping them stay in the same position over time".
"When breast implants are placed in the body, they are inserted behind the breast tissue or under the chest muscle", the letter from the said.
The report also detailed that most of cancer cases were found in women with textured surfaces on the implants rather than implants with a smooth exterior. Over time, a fibrous scar called a capsule develops around the implant, separating it from the rest of the breast. The majority of ALCL cases have been linked to the textured devices.
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