Breast cancer patients and women who want to feel more confident have already put themselves at risk by undergoing surgery, believing that the implants are safe and won’t cause undue harm to their bodies.
Motley Rice medical device attorneys are taking on Allergan, one of the world’s largest breast implant manufacturers, for allegedly putting profits over women’s health.
In July 2019, at the FDA’s urging, Allergan issued a voluntary worldwide recall of its Biocell® textured breast implants and tissue expanders because women with the implants developed breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare form of non-Hodgkin’s lymphoma. Some victims have filed litigation alleging Allergan knew the potential cancer risk associated with its breast implants and tissue expanders, but that the company failed to report the risk to the FDA and did not let women know of the potential danger.
FDA warns manufacturer for failing to comply with regulations
May 14, 2020
The FDA sent a warning letter to Allergan, reprimanding the medical device manufacturer for failing to comply with regulations regarding its recalled breast implants. Allergan’s failure to adequately follow-up on the long-term safety effects of its recalled Biocell textured breast implants is “unacceptable,” the FDA said. Read more.
Contact a Breast Implant Lawyer
If you or a loved one received a breast implant-associated anaplastic large-cell lymphoma diagnosis, you may have a legal claim. For more information, you may contact Motley Rice medical device lawyers Sarah Hansel, Esther Berezofsky at 1-800-768-4026 or by email.
Motley Rice attorneys and staff have experience in medical device litigation, including cases involving Allergan, a company that manufactures some types of breast implants that were the subject of the July 2019 voluntary recall.
Motley Rice’s Breast Implant and Women’s Litigation Experience
Motley Rice is on the front lines representing thousands of women harmed by defective medical implants and we have represented women with defective breast implants since Motley Rice began. Now, we are fighting for women who have developed BIA-ALCL as a result of Allergan’s negligence. Our lawyers and support staff have extensive experience litigating cases involving serious complications from implanted medical devices and drugs, including, including transvaginal mesh, Essure® and birth control such as IUDs.
What is BIA-ALCL?
Breast Implant Associated Lymphoma (BIA-ALCL) is a type of non-Hodgkin's lymphoma (cancer of the immune system). In most cases, BIA-ALCL is found in the scar tissue and fluid near the breast implant. BIA-ALCL is serious and can lead to death, especially if not treated promptly. In most patients, it is treated with surgery to remove the implant and surrounding scar tissue. Some patients also require treatment with chemotherapy and radiation therapy.
What are the symptoms of BIA-ALCL?
Breast lumps, breast swelling, breast hardening, breast pain and capsular contracture may all indicate BIA-ALCL. These symptoms may occur well after the surgical incision has healed, often years to a decade or more after implant placement. If you are experiencing any of these symptoms, you may want to talk to your doctor about undergoing a test for BIA-ALCL.
Breast Implant-Associated ALCL Background
- The FDA updated its global medical device reports for BIA-ALCL received through January 5, 2020. The FDA reported 733 total BIA-ALCL cases. Of those, 620 were women with Allergan implants.
- In July 2019, at the FDA’s urging, Allergan issued a worldwide voluntary recall of its Biocell textured breast implants and tissue expanders due to alleged links to the rare cancer BIA-ALCL. Visit www.biocellinformation.com for more information on the recall.
- The FDA has received at least 359 reports of such cancer development, including nine deaths. Of the reported incidents, the vast majority involved textured implants.
- Australian Therapeutic Goods Administration updates its findings of at least 53 confirmed cases of breast implant-related cancer development in Australia, including at least three deaths.
- The New York Times published a series on BIA-ALCL:
- March 21, 2017: 9 deaths are linked to rare cancer from breast implants
- May 14, 2017: What you need to know if you have breast implants
- May 14, 2017: A shocking diagnosis: breast implants ‘gave me cancer’
- The World Health Organization recognized breast implant-associated ALCL as a rare T-cell lymphoma. The disease usually presents roughly 10 years after the device was first implanted, according to WHO, and complications can lead to implant removal, chemotherapy, other aggressive treatments, and possibly death.
- In cases where breast implant-associated ALCL were reported, abnormal cell growth typically developed in seroma fluid that accumulated between the implant and the surrounding fibrous capsule, according to WHO. While in most cases the issue may resolve by removing the implant, other instances in which the abnormal cell growth spreads, potentially endangering the lymph nodes, may require chemotherapy.
- The French National Agency for Medicines and Health Products Safety asked textured breast implant manufacturers to conduct biocompatibility tests on the devices and report results to the agency within a year.
- The FDA first released a report identifying a possible correlation between certain breast implants and ALCL
The FDA continues to collect and evaluate data on the issue. To report the development of breast implant-associated ALCL, visit the FDA online.
Motley Rice LLC, a South Carolina Limited Liability Company, is engaged in the New Jersey practice of law through Motley Rice New Jersey LLC. Esther Berezofsky is the attorney responsible for New Jersey practice.