Written by: Laura Beasley, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
It is likely that many of you, at this point, have heard about the issue of BIA-ALCL and may know someone who has had it.
Breast Implants and Rare Blood Cancer
BIA-ALCL is Breast Implant-Associated Anaplastic Large Cell Lymphoma. We have monitored this type of cancer and its relation to breast implants for quite some time now. You can refer to several of our past articles to learn more background on the subject matter. “2019 Discoveries and Warnings on Breast Implant-Associated Lymphoma” is our most recent article as regards general information. The longer we monitor this issue, the greater the concern about it becomes.
Due to the fact that this type of cosmetic surgery is the most popular one in the United States, hundreds of thousands of women undergo it. This means that hundreds of thousands of women are at risk, and many of them never warned.
Now that more diagnoses are popping up and the issue is being taken more seriously, the FDA decided that it is time to address this in front of the public. This is in efforts to ensure that women and medical doctors are warned and understand the risks, and to call out the manufacturing companies who have not been compliant.
The article we published on March 22, 2019, "Lymphoma Cancer Associated With Breast Implants: FDA Advisory Committee Meeting March 2019" provides an outline as to the March 25-26, 2019 FDA CDRH General and Plastic Surgery Devices Advisory Committee Meeting.
FDA on the Issue
The FDA recently published an article in March 2019, “FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements” which informs that 2011 is when the FDA first acknowledged that there may be a link between breast implants and this type of cancer. However, it was extremely rare and there could be no conclusion as regards the relationship.
Now that the FDA is making formal public statements about the association, the risks are becoming more evident, which is something many women had not been aware of.
The March 2019 FDA article makes the statement, “Breast implants are not lifetime devices and the longer a patient has the implants, the more likely they are to experience local complications and adverse outcomes requiring breast implant removal”
The amount of women who have been or are diagnosed with BIA-ALCL has risen significantly in the past few years.
Educating and Warning the Public while Calling out Manufacturers
As mentioned, days after the FDA issued the two warning letters, they conducted an advisory committee meeting in which they called out breast implant manufacturers such as Mentor Worldwide LLC in Irvine, California and Sientra, Inc. of Santa Barbara, for not conducting mandatory studies on post-op patient satisfaction. We get this information from the March 2019 FDA article:
Breast implant post-approval studies designed at the time of device premarket approval to follow patients longitudinally and answer our long-term questions have been unreliable. Poor compliance and changes in surgical practice over time have produced results difficult to interpret in a generalized manner much less with the precision needed to deliver personalized patient care.
These post-approval studies were supposed to follow-up with patients who were enrolled in the study. A specific number of patients to be enrolled was set by the FDA. The main issues arose in the facts that these companies simply did not have near the correct number of women in the studies as well as very low follow-up rates.
Additionally, the FDA meeting that took place included hearing from the companies that manufacture the legal, approved breast implants: Allergan, Mentor, Sientra, and IDEAL. It also heard from advocates who shared their personal experiences with this issue.
An article related to the subject from The Washington Post, “Women who say they were sickened by breast implants demand FDA action: ‘I was not warned.’,” stated:
Many of the advocates who spoke on Monday called for a ban on textured implants – the kind strongly linked to the cancer. There is some evidence the problem could be caused by bacterial infections involving the implants, researchers said.
As stated before, but emphasized now, we recommend that anyone thinking about undergoing such a procedure or already has, should speak with their medical doctor about the risks associated.
Visit our Breast Implants Lymphoma Cancer page on our website for more information.