Warning Letters Sent To Companies Mentor Worldwide And Sientra For Breast Implants Safety Monitoring Failures
Albeit a bit off-topic for the general focus of this Drug Injury Watch blog, we have been monitoring and writing about Breast Implant Associated Anaplastic Large-Cell Lymphoma (BIA-ALCL) for the past two years. Over that time period, the FDA has become more and more interested in this lymphoma cancer "side effect", if you will, as well as other breast implant safety issues. This increased concern is now culminating in a two-day meeting of medical experts to be convened next week.
Specifically, there will be an FDA CDRH General and Plastic Surgery Devices Advisory Committee Meeting held on March 25-26, 2019. As the FDA Agenda document for this meeting shows, the first day will be focused in large part on the lymphoma cancer associated with breast implants, ALCL, which 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 the March 25-26, 2019 breast implants meeting. Those items are set forth below:
- Meeting Information for the Public: March 25-26, 2019 (PDF - 53KB)
- Agenda: March 25, 2019 (PDF - 145KB)
- Agenda: March 26, 2019 (PDF - 118KB)
- FDA Executive Summary: March 25-26, 2019 (PDF - 848KB)
- FDA Executive Summary Appendix: March 25-26, 2019 (PDF - 70KB)
- Panel Questions: March 25-26, 2019 (PDF - 71KB)
- Roster: March 25-26, 2019 (PDF - 50KB)
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.
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Moving onto a different aspect of the breast implant safety topic, on March 19, 2019 there appeared this FDA News Release, "FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements".
This excerpt comes from the start of that March 2019 FDA document:
Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants.
The FDA issued warning letters to Mentor Worldwide LLC of Irvine, California, and Sientra, Inc. of Santa Barbara, California. Every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies to further evaluate safety and effectiveness of the products and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their premarket clinical trials were not designed to answer.
For those who want to know more, you can read one or both of the FDA warning letters to those breast implant manufacturers:
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.