When you have a medical procedure, you expect a certain level of assurance that the products being used are safe. That turns out to not be the case for breast implants produced by Allergan Plc, which has recalled all of their Biocell textured implants at the direction of the FDA.
Sales of Allergan’s textured implants – and textured implants manufactured by several other companies – have already stopped in Europe due to a ban in France, been banned in Canada, and are on the docket to be banned in Australia. The other manufacturers include Arrion, Sebbin, Nagor, Eurosilicone, and Polytech.
Who is affected?
Patients who have the following implants or tissue expanders are affected by the recall:
- 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
If you or someone you know has one of the above listed products, or any textured breast implant, there may be increased risk for Breast Implant-Associated Anaplastic Large Cell Lymphoma, or BIA-ALCL. BIA-ALCL is actually a cancer of the immune system, rather than the breast.
What is the risk?
The Cleveland Clinic says that symptoms of BIA-ALCL include swelling or fluid accumulation in the breast or around an implant; lumps; pain; changes in the shape or size of the breast or breasts; and redness.
According to the FDA, “evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death.” They state that as of July 2019, there were a recorded 573 cases of BIA-ALCL globally, and 33 deaths.
CNN quoted Dr. Colleen McCarthy of Memorial Sloan Kettering Cancer Center as saying that “Most patients diagnosed with BIA-ALCL will be cured by removal of both breast implants along with the scar tissue, or capsule, surrounding each implant. A small minority of patients will also require chemotherapy and radiation.”
Who can help?
If you’ve been diagnosed with BIA-ALCL and have one of Allergan’s recalled products or other textured breast implant, Belluck & Fox LLC can help. No one should have to fight for their health alone.
With over two decades of experience standing up for patients, we are committed to finding justice for you. We will provide a free consultation, and if we can take on your case, promise to fight for you and your family as if it were our own.