Allergan has issued a worldwide recall of its Biocell textured breast implants and tissue expanders, CNN reports. The products have been linked to a rare type of breast cancer: breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). In April, France, Canada and the Netherlands all suspended or banned sales of textured breast implants.
The Food & Drug Administration (FDA) requested that Allergan recall their breast implants and tissue expanders. This is an about-face from May, when the agency concluded that while there are numerous reports linking textured breast implants with cancer, the risk was not high enough to justify taking the implants off the U.S. market.
According to the FDA’s latest official statement, “once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health.” The data shows that of the 573 cases of BIA-ALCL, 481 were attributed to Allergan’s implants. Furthermore, “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.”
The following textured breast implants and expanders have been recalled:
- Natrelle Saline-Filled breast implants
- Natrelle Silicone-Filled breast implants
- Natrelle Inspira Silicone-Filled breast implants
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
- Natrelle 133 Plus Tissue Expander
- Natrelle 133 Tissue Expander with Suture Tabs
According to CNN, the FDA is not recommending removal of the breast implants or expanders for patient who are not exhibiting signs of BIA-ALCL.
Breast implants and cancer
Patients choosing breast augmentation surgery have many types of implants from which to choose – saline, structured saline, silicone, smooth or textured. Textured implants are designed to form scar tissue around the implant, making it stick to the surface, which in turn makes the implants less likely to move around. Textured breast implants also decrease the risk of side effects that can result in hard or unnatural looking breasts.
Despite these attributes, France, Canada and the Netherlands halted sales of the implant after studies on BIA ALCL revealed the increased risk. This is a rare cancer that forms within the scar tissue around the breast implant. While breast cancer affects the tissue of the breast, BIA-ALCL primarily affects the scar tissue only, but can spread to the lymph nodes if left untreated.
Working with an experienced defective device attorney
Why did it take this long for the FDA to recommend a recall? Why did it take this long for Allergan to issue that recall? These breast implants have been linked to 480 cases of cancer and potentially as many as 32 deaths. What is the reason for leaving them in place with that risk?
The FDA has known about the potential links between breast implants and BIA-ALCL since 2011, and as of two months ago, failed to ban textured breast implants despite that link. We have no idea how many women may have developed a preventable cancer because the FDA refused to ban these products years ago. We do know, however, that the manufacturer of these defective products must be held to account for the role they played in so many women developing a life-threatening cancer.
Harris Lowry Manton LLP is one of the leading product liability law firms in Georgia, and has secured millions of dollars on behalf of our clients. We routinely go up against global and national companies who put their profits ahead of their customers’ safety. If you or a loved one has Biocell textured breast implants and have been diagnosed with BIA-ALCL, contact us today to learn how we can help. Schedule a consultation at 404-961-7650 at our Atlanta office, in Savannah at 912-651-9967, or fill out our contact form.