We have consistently provided updates on the situation of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) in relation to textured implants. Every article prior to this one has discussed how other countries have banned textured breast implants or how the FDA has been monitoring the issue. As of July 24, 2019 the FDA has finally joined in with the many other countries by recalling specific textured breast implants.
Allergan Implants Recall
We learn from the recent FDA News Release that the manufacturer at the forefront of this FDA decision is Allergan and the type of products are their BIOCELL textured breast implants and tissue expanders. Several products fall under this category:
- Natrelle Saline-Filled breast implants
- Natrelle Silicone-Filled breast implants
- Natrelle Inspira Silicone-Filled breast implants
- Natrelle 410 Highly Cohesive Automatically Shaped Silicone-Filled breast implants
- Natrelle 133 Plus Tissue Expander
- Natrelle 133 Tissue Expander with Suture Tabs
According to the news release, FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., notes that even though the incident rate is rare, the fact that Allergan’s product in particular strongly correlated with BIA-ALCL diagnoses and deaths caused the recall action to be taken.
Reason for Recall
As mentioned in our most recent previous article, “Statistics Show An Increased Risk For BIA-ALCL With Textured Implants”, the numbers for the population at risk is rising and so are the number of diagnoses. This FDA News Release gives the most current update:
573 unique cases globally of BIA-ALCL and 33 patient deaths, which reflect a significant increase in known cases of BIA-ALCL since the agency’s last update earlier this year —an increase of 116 new unique cases and 24 deaths. Specifically, of the 573 unique cases of BIA-ALCL, 481 are attributed to Allergan implants. Of the 33 patient deaths the FDA is reporting today, 12 of the 13 patients for which the manufacturer of the implant is known, are confirmed to have an Allergan breast implant at the time of their BIA-ALCL diagnosis.
Additionally, the recent FDA Safety Communication informs that:
The risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S.
It has been known that other countries have already banned textured breast implants for quite some time. Allergan’s products in Europe, for example, were banned in 2018.
The New York Times just published an article, “Breast Implants Linked to Rare Cancer Are Recalled Worldwide“, where Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, noted that, “The data regarding deaths was particularly informative of our decisions.”
Beyond the Recall
In furtherance of this recall notice, this New York Times article mentions that the FDA may be taking other steps in furtherance of the recall notices:
They also said they were considering changes to the labeling of breast implants, like adding a black-box warning to draw attention to the risks, and requiring doctors and patients considering the surgery to go over a checklist to help women understand the benefits and risks of the devices.
It has been our continued understanding that textured breast implants pose a much higher risk of BIA-ALCL than other types. According to a recent Reuters article, “Allergan recalls textured breast implants worldwide”, the manufacturer’s BIOCELL implants have a risk nearly six times more than other manufacturers such as Mentor / Johnson & Johnson and Sientra Inc.
This article relays information from Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, who said, “The FDA is still assessing if the risk of developing BIA-ALCL is limited to specific models of textured, or all textured breast implants”
It is refreshing to learn that the FDA has concluded the risk of BIA-ALCL with textured breast implants, specifically Allergan’s, to be too high. This decision will ideally lead to a decrease in diagnoses and deaths, as well as, allowing all women and medical professionals to be educated when considering breast implants.
Written by: Laura Beasley, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.