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The Allergan Breast Implant lawsuits claim textured breast implants can cause anaplastic large cell lymphoma (ALCL), a rare form of non-Hodgkin’s lymphoma.
Our law firm is representing women who received textured breast implants and have subsequently been diagnosed with ALCL.
We have been handling lawsuits against medical device manufacturers since 1955. Each year we teach 1,500 attorneys how to successfully handle these cases. We are listed in Best Lawyers in America and The National Trial Lawyers Hall of Fame.
According to the World Health Organization and United States Food and Drug Administration (“FDA”), breast implants are linked to anaplastic large cell lymphoma, a rare form of non-Hodgkin’s lymphoma typically located in the scar capsule surrounding the implant.
The illness has been termed breast implant-associated anaplastic large cell lymphoma (“BIA-ALCL”). This illness has predominantly been reported in patients with textured breast implants, although there have been some ALCL reports involving women who have received smooth breast implants.
In 2016, the World Health Organization officially designated BIA-ALCL as a form of T-cell lymphoma that can develop following breast implantation. In December 2018, sales of textured Allergan breast implants were suspended in all 33 countries in Europe as well as Israel, Brazil, and Australia. In May 2019 Health Canada suspended Allergan’s license for its BIOCELL breast implants after an internal safety review concluded that these implants conferred an increased risk of ALCL.
Allergan, a manufacturer of textured breast implants, was forced to recall their implants after numerous reports of women suffering anaplastic large cell lymphoma.
In May 2019, the FDA held a two day Advisory Committee meeting to discuss the risks and benefits of breast implants and to make recommendations regarding appropriate actions to take in light of concerns related to BIA-ALCL. On July 24, 2019, the FDA announced that it was taking action to protect patients by requesting that Allergan voluntarily recall all of its textured breast implants and associated tissue expanders from the U.S. market.
The FDA decided to request this recall after a review of newly-submitted adverse event reports involving BIA-ALCL. The FDA noted that it found “the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S. and that “continued distribution of Allergan’s BIOCELL textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.”
Breast implant-associated anaplastic large cell lymphoma is not breast cancer. It’s a form of non-Hodgkin’s lymphoma. The disease is caused by the mutation of a specific gene which causes T-cells to produce excess amounts of a protein known as anaplastic lymphoma kinase (ALK1).
It is not known why textured implants can cause this cancer. However, research suggests that it may be linked to the inflammation that results in the formation of the scar tissue, which in turn holds the implants in place. It is also possible that bacterial contamination at the surgical site may play a role, as well as a family history of lymphoma.
An individual’s risk of developing BIA-ALCL is believed to be low, but is serious and can lead to death. Initial symptoms of ALCL usually consist of a painless, but noticeable swelling in the lymph nodes (for example, the armpit or neck). This may be followed by a loss of appetite, generalized fatigue, fever, and night sweats. There also might be a mass or pain in the area of the breast implant. An accurate diagnosis requires the analysis of an enlarged lymph node in order to determine if lymphoma cells are present.
As of January 5, 2020, a total of 733 cases of anaplastic large cell lymphoma associated with breast implants were submitted to the FDA. Of these, 620 (85%) reports involved Allergan breast implants, 66 (9%) reports involved implants manufactured by Mentor, Sientra, and other companies, and 47 (6%) reports did not identify the implant manufacturer. These BIA-ALCL reports included 36 deaths. Based on the available adverse event data, the median time from implantation to diagnosis of ALCL is 8 years.
If detected early enough, BIA-ALCL can often be successfully treated by removal of the implant and surrounding scar tissue. However, ALCL can metastasize to other parts of the body and treatment with chemotherapy and radiation may be required. Early diagnosis is of utmost importance.
If you or a loved one experienced anaplastic large cell lymphoma (ALCL) after having breast implants, then we will be seeking the following damages for you:
In December 2019, an MDL was established for Allergan textured breast implants in federal court in New Jersey. Our law firm is serving as co-lead counsel for the MDL. As of October 2021, more than 900 lawsuits were pending in the MDL.
The creation of an MDL is the first step in the litigation process that starts the settlement negotiations. Once the MDL has been formed, discovery of the facts and trials can begin, which then leads to serious settlement discussions.
The FDA said in a statement that while the overall incidence of the cancer appears to be low, it asked Allergan to initiate the Biocell implant recall “once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death.” Reported in NPR
Research suggests that BIA-ALCL is usually found near the breast implant within the surrounding scar tissue, not the breast itself. The lifetime risk of developing BIA-ALCL from a textured implant is estimated to be from one in 1,000 to one in 30,000. Treatment involves surgical removal of the implants and the cancer. When caught early, BIA-ALCL is usually curable. Reported in Mayo Clinic
In October 2020, the FDA issued non-binding recommendations and guidance regarding the following warnings to be conveyed to women considering breast implants. (1) breast implants are not considered lifetime devices; (2) the chance of developing complications increases over time; (3) some complications will require more surgery; (4) breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL); BIA-ALCL occurs more commonly in patients with textured breast implants than smooth implants, and deaths have occurred from BIA-ALCL; and (5) breast implants have been associated with systemic symptoms.
Breast Implant Associated Lymphoma (BIA-ALCL) is not breast cancer – it 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 implant, but in some cases, it can spread throughout the body. An individual’s risk of developing BIA-ALCL is considered to be low; however, this cancer is serious and can lead to death, especially if not treated promptly.
As of January 5, 2020 , the Food and Drug Administration (FDA) has received a total of 733 US and global medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
The FDA took action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL.
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