Around 400,000 women get breast implants in the US each year, either for cosmetic reasons or after undergoing surgery for breast cancer. However, one pharmaceutical company’s implants have been found to raise a woman’s risk of developing cancer, prompting a recall.
In July 2019, the Food and Drug Administration (FDA) requested pharmaceutical company Allergan to voluntarily recall all BIOCELL textured breast implants and tissue expanders marketed in the US, after it was determined that they increase the risk of Breast-Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a cancer of the immune system.
Which products were recalled?
Following the FDA’s request, the following Allergan Natrelle BIOCELL Textured Products were recalled:
- Allergan Natrelle Saline-Filled Textured Breast Implants
- Allergan Natrelle Silicone-Filled Textured Breast Implants
- Allergan Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Textured Breast Implants
- Allergan Natrelle 133 Plus Tissue Expander
- Allergan Natrelle 133 Tissue Expander with Suture Tabs
What exactly is BIA-ALCL?
Breast Implant-Associated Anaplastic Large
Cell Lymphoma is a rare type of T-cell Lymphoma (cancer of the immune system). It typically develops in the scar tissue capsule and fluid surrounding a breast implant, and can spread throughout the entire body.
While BIA-ALCL is curable in most patients if it is diagnosed early and treated properly, some have died from it. Symptoms can develop many years after a patient undergoes implant surgery.
Symptoms of BIA-ALCL include:
- Swelling or pain in the breast area
- Fluid accumulation in the breast area
- Lump adjacent to the implant surface
- Lump in the lymph node in the armpit
- Changes in the shape or size of the breast or breasts
- Enlarged lymph nodes
- Skin rash
- Weight loss
If you experience these symptoms, you are advised to seek medical attention right away.
Understanding the risks
The FDA’s analysis of Allergan’s products found that patients with BIOCELL textured breast implants and tissue expanders were six times more likely to develop BIA-ALCL than patients who received similar products from other manufacturers.
BIA-ALCL is very rare, which makes the numbers cited by the FDA especially staggering. Of 573 worldwide total cases, 481 people were reported to have Allergan breast implants at the time of their diagnosis. Twelve of those people died.
“Continued distribution of Allergan’s BIOCELL textured breast implants would likely cause serious, adverse health consequences, including death, from BIA-ALCL,” the FDA wrote in a statement.
Who may be affected?
Patients who have any of the above mentioned Allergan implants or tissue expanders are affected by the recall. In addition, surgeons who have implanted the products, as well as health care providers who treat patients with implants, have all been exposed to the risk.
If you or a loved one have received Allergan BIOCELL implants or tissue expanders, you could be entitled to compensation including:
- Medical bills
- Pain and suffering
- Disability or permanent injury
- Lost wages/loss of earning capability
- Punitive damages
- Rehabilitation costs
- Wrongful death
Contact McWhirter, Bellinger & Associates for a free case evaluation
The defective products attorneys at McWhirter, Bellinger & Associates would love to hear about your experience and give you a free case evaluation. Our lawyers are highly trained in the areas of personal injury and wrongful death, and have a proven track record of fighting to get victims the compensation they are owed.
Contact us today at 803-373-7988. It won’t cost you anything to see if we can help.