There was an FDA CDRH General and Plastic Surgery Devices Advisory Committee Meeting held on March 25-26, 2019. The first day was focused in large part on Breast Implant Associated Anaplastic Large-Cell Lymphoma (BIA-ALCL). This lymphoma cancer associated with breast implants is a rare type of blood cancer that is classified as a non-Hodgkin lymphoma, and one of the sub-types of T-cell lymphoma.
As is customary for FDA Advisory Committee Meetings, background materials and specific panel questions were released by the FDA prior to this March 2019 breast implants meeting. From the FDA Executive Summary document, titled “Breast Implant Special Topics”, we get this focal point:
Breast implants are associated with BIA-ALCL, a cancer of the immune system. While most patients with BIA-ALCL may be treated only with breast implant removal, some patients have required radiation therapy, chemotherapy or both, and some patients have died from BIA-ALCL. [See “Introduction”, at page 5]
A more detailed discussion of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) can be found at pages 13-18 of this FDA Executive Summary document.
As our law firm has been actively investigating BIA-ALCL cases for women as possible lawsuits against these companies and other breast implant manufacturers, we applaud the increased scrutiny that the FDA is bringing to the breast implant safety issue.
If you want to learn more about this issue, you can start at our Breast Implants Lymphoma Cancer information page.[View full article at original source]
Strictly Confidential, No Obligation.