Sanders Phillips Grossman, one of the nation’s leading defective medical device law firms, is filing lawsuits on behalf of textured breast implant recipients who were diagnosed with a rare type of cancer known as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
The Food and Drug Administration (FDA) recently requested that Allergan recall their BIOCELL textured breast implant products, including Natrelle implants. In addition to Allergan, our attorneys have identified textured implants made by Polytech, Nagor, Mentor, Motiva, and Sientra as litigation targets.
FDA and manufacturers have been aware of a possible link between textured breast implants and cancer since at least 2011. Despite this, voluntary recalls were not issued, and many women say that implant cancer risks were not adequately conveyed to them. FDA estimates that hundreds of thousands of U.S. women have textured implants.
If you underwent breast augmentation surgery using textured implants and were diagnosed with BIA-ALCL, you may qualify for a lawsuit. Contact Sanders Philips Grossman immediately for your free case review.
Allergan Recalls Textured Breast Implants
Breast implant maker Allergan issued a worldwide recall of certain textured implants on July 24, 2019 following a request by the FDA. FDA requested the recall based on new evidence about recipients’ risk of BIA-ALCL.
According to FDA, as of July 6, 2019, there have been 573 unique cases globally of BIA-ALCL and 33 patient deaths. More than 80 percent of these cases have been linked to Allergan textured implants. FDA estimates that the risk of cancer is six-times higher with Allergan textured implants than with textured implants made by other companies.
This is an abrupt turnaround for the FDA, which just a few months ago said it would not ban textured breast implants. FDA decided to act now because over the past few months, it has uncovered a significant increase in known cases of BIA-ALCL, including 116 new unique cases and 24 deaths. Based on this data, FDA concluded that action is necessary. Along with the recall, FDA issued a safety communication for breast implant patients.
Symptoms of BIA-ALCL
BIA-ALCL is type of non-Hodgkin’s lymphoma (cancer of the immune system) rather than a form of breast cancer. Case studies describe the disease typically forming in the fluid surrounding the breast implant, between the tissue capsule (scar tissue that forms around the implant) and the implant.
Without treatment, the disease can spread to the surrounding tissue and other areas of the body, including the lymph nodes. The lifetime risk of textured implant recipients developing BIA-ALCL is estimated to be between 1 in 3,000 patients and 1 in 30,000 patients.
Researchers are uncertain why textured breast implants can trigger lymphoma. They theorize that it may be due to the greater surface area of the implants, inflammation of the surrounding tissue, or genetic reasons.
Symptoms of BIA-ALCL, which can appear 2 to 28 years after a breast implant procedure, may include:
- Pain and/or swelling near the breast implant
- Lump(s) in the breast or armpit
- Fluid buildup around the breast implant
- Hardening of the breast
- Skin rash or redness overlying the implant area
- Changes in the shape or size of the breast(s)
The average length of time before symptoms appear is eight years after implantation. If you notice any change in the size or shape of your breast, make an appointment to see your plastic surgeon right away. Routine mammograms or breast X-rays will not detect BIA-ALCL. Your doctor may order diagnostic testing, such as an ultrasound, MRI, or needle biopsy.
A positive BIA-ALCL test usually necessitates removal of the breast implant and surrounding scar capsule. However, FDA does not recommend implant removal for patients with no symptoms.
Which Textured Breast Implants are Linked to Lymphoma?
Allergan is removing the following BIOCELL textured breast implant products and tissue expanders from the market:
- 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
In addition to Allergan BIOCELL breast implant products, Sanders Phillips Grossman attorneys are investigating claims related to these types of textured breast implants:
- Polytech Microthane
- Nagor Nagotex
- Mentor Memory Gel Textured
- Mentor Memory Shape
- Motiva Silk Surface
- Sientra OPUS Textured
Approximately 400,000 U.S. women receive breast implants each year. Allergan’s textured breast implants represent less than 5 percent of all breast implants sold in the U.S., while textured implants account for only 10 percent of all U.S. breast implants. Compared to smooth implants, textured implants have a thicker outer shell and tend to create a firmer feel. Some patients’ physical anatomy makes textured implants a better choice.
Do I Have a Case?
Manufacturers may have failed to adequately warn consumers and healthcare providers about the cancer risks their breast implants pose. Many women we’ve spoken to say they would not have received their breast implants had they fully understood the health hazards involved.
You may be eligible for a lawsuit against Allergan or another implant manufacturer if you meet the following criteria:
- You were implanted with a textured implant between 1997 and 2019 (regardless of whether the procedure was cosmetic or reconstructive)
- You have been diagnosed with BIA-ALCL
- You can prove your injury with documentation such as:
- Mammogram or ultrasound
- Pathology report
- PET scan
- Operative report for excision of lymphoma
- Chemotherapy/radiation therapy treatment plan
- Breast implant card and implant medical records
- Explant (implant removal) medical records
Receive a Free Breast Implant Lymphoma Case Review
Breast implant recipients who meet the criteria outlined above are encouraged to contact Sanders Phillips Grossman for a complimentary case evaluation. You may qualify for compensation, but the time to file a lawsuit is limited, so you must act fast.
It takes an extremely experienced and knowledgeable legal team to take on powerful medical device manufacturers like Allergan. Our lawyers are recognized as national leaders in defective device litigation. We handle cases on a contingency-fee basis, which means you pay nothing unless we recover money for you.
To start your free case review, call 1-800-530-9800 or contact us.