Written by: Laura Beasley, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
As we have continuously discussed here, textured breast implants are being banned in some countries not including the U.S. You can refer to our most recent previous article on the topic, “U.S. FDA Refrains from Textured Implants Ban”, to explore what has happened thus far worldwide as regards banning textured breast implants due to the risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
The FDA’s Reasoning
It is our understanding that the FDA is choosing to not ban textured breast implants in the U.S. due to the lack of a strong causal relationship between this particular type of implant and BIA-ALCL.
In March of this year, the FDA sent out warning letters to both Allergan and Mentor because they did not conduct the necessary post-approval study requirements. An April 2019 article of ours, “March 2019 FDA Meeting on Breast Implants: A Summary Of What You Need To Know”, can provide you with the information contained in the warning letters and details about the post-approval studies.
Statements from the Manufacturers
Healio just published an article, “FDA weighs breast implant risks, benefits amid links to cancer, other illnesses”, which includes statements from representatives of both Allergan and Mentor defending their companies’ products.
Both vice presidents from Allergan and Mentor / Johnson & Johnson have expressed similar thoughts about their companies' products in response to the FDA's warning letters. Essentially, they both vouch that their breast implants are monitored and supported by large and long-term clinical studies. In response to the warning about their memory shape implants, Raina Dauria of Mentor / Johnson & Johnson adds:
The use of textured devices in the U.S. has decreased substantially, and Mentor has been challenged in enrolling this study group, despite taking steps to increase enrollment.
As regards the general discussion of potential risk of BIA-ALCL, Stephanie Manson Brown, MD, of Allergan shares:
Patients with BIA-ALCL can have an excellent prognosis when identified early and treated appropriately... the leading hypothesis centers around biofilm and there are three likely factors that contribute to this, including procedure, product and patient.
This May 2019 Helio article also discusses the onset of symptoms of BIA-ALCL, from the perspective of The University of Texas MD Anderson Cancer Center, with delayed seroma as apparently being the most prominent symptom. Mark Clemens, MD, notes the association between specific brands of implants and the risk of BIA-ALCL. That risk is apparently 7.1 to 8.3 times higher with Allergan Biocell implants compared to all other manufacturers combined.
Canada in Contrast
Allergan may have only received a warning letter in the U.S., but in Canada its sales are being put to a halt. Two days ago Canada’s government website published the article, “Health Canada suspends Allergan's licences for its Biocell breast implants after safety review concludes an increased risk of cancer”, which informs that Health Canada has determined a much higher risk of BIA-ALCL in relation to macro-textured implants, this being 85% of the 26 confirmed cases in Canada. As a result, they have suspended the sale and import of Allergan’s Biocell breast implants and Allergan is voluntarily recalling such unused implants.
An article from Reuters published on the same day, “Allergan to recall textured breast implants in Canada” delivers this quote:
Health Canada’s decision is in contrast to public rulings and positions by other regulatory bodies around the world, including the U.S. Food and Drug Administration’s (FDA) recent position, Allergan said.
With such a strong conclusion from Health Canada regarding the risk of BIA-ALCL from textured implants and the hundreds of women who have been diagnosed, even some deaths occurring, we should wonder... is the FDA going to change its mind?
We encourage you to visit our Breast Implants Lymphoma Cancer page on our website for more information on the topic of breast implants and BIA-ALCL.