FDA Reports on Risk of Lymphoma from Breast Implants
Since this disease is not well-studied yet, the Food and Drug Administration (FDA) has provided medical device reports (MDRs), also known as adverse events reports, and medical literature estimates related to risk. In addition, the agency has released an update on its current understanding of the disease.
Since its last public update in March 2017, the FDA announced it is aware of 414 total cases of BIA-ALCL, for which studies estimate that the lifetime risk of developing the disease for those with textured breast implants ranges from 1 in 3817 to 1 in 30,000.
The FDA is not changing its recommendations regarding breast implants as of this report, but it will continue to track news and studies going forward.
More Cases Are Reported of Unusual Cancer Linked to Breast Implants
More cases of an unusual cancer linked to breast implants have been reported to the Food and Drug Administration, the agency said on Wednesday.
The case count rose in the past year, to 414 cases from 359, the agency said in an update on its website. The number of deaths it has recorded, nine, has not changed from one year ago; a professional society of plastic surgeons is now reporting 16 related deaths.
The F.D.A.’s figures include cases from the United States and other countries. The agency began publicly reporting on the problem in 2011, and some of the apparent rise in cases may be due to increased awareness and diagnosis.
The disease is not breast cancer, but is a malignancy of the immune system called breast implant-associated anaplastic large-cell
