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Breast Implants & Cancer Diagnosis
June 2, 2020
Case Update: FDA warns manufacturer for failing to comply with regulationsThe 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.
In July 2019, at the FDA’s request, breast implant manufacturer Allergan issued a worldwide voluntary recall of its Biocell® textured breast implants and tissue expanders due to claims of women with the implants developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare form of non-Hodgkin’s lymphoma.
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 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.
Anaplastic Large Cell Lymphoma Symptoms
In its initial stages, ALCL symptoms can include:
- Painless swelling of lymph nodes
- Loss of appetite
It’s common for women to also experience pain, lumps, fluid buildup and swelling at implant sites prior to a diagnosis.
FDA data shows that the rare cancer BIA-ALCL occurs more frequently in women with textured surface breast implants than implants with smooth surfaces.
Studies are ongoing to determine why BIA-ALCL is more prevalent with textured breast implants. In some cases, the cancer seems to be associated with a certain bacterial infection.
Breast Implant-Associated ALCL Background
- In July 2019, at the FDA’s request, manufacturer 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 FDA continues to collect and evaluate data on the issue. To report the development of breast implant-associated ALCL, visit the FDA online.
- 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 and 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
Motley Rice’s Breast Implant and Women’s Litigation Experience
Our attorneys have experience representing thousands of women harmed by defective medical devices, including transvaginal mesh, Essure® and birth control such as IUDs. Our lawyers are assisted by support staff who have also assisted thousands of people who have experienced serious complications from prescription drugs and medical devices.
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.