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Breast Implant Associated BIA-ALCL Cancer Lawsuit Information

Washington, DC: The US Food and Drug Administration (FDA) issued an update in line with the World Health Association guidance, which designates breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare but highly treatable T-cell lymphoma that can develop following breast implants. Physicians are increasingly aware of the need to tell patients about this risk before surgery in order to obtain informed consent and to increase the chance of detection and successful treatment..


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Breast Implants and Cancer

BIA-ALCL is a cancer of the immune system, not a form of breast cancer. According to information from the American Society of Plastic Surgeons, a woman’s lifetime risk of this complication is between 1:3817 and 1:30,000 women with textured implant. The condition has been found with both silicone and saline implants and both breast cancer reconstruction and cosmetic patients. To date, there are not any confirmed BIA-ALCL cases that involve only a smooth implant.

Common symptoms include breast enlargement, pain, asymmetry, lump in the breast or armpit, overlying skin rash, hardening of the breast, or a large fluid collection. The symptoms do not develop until at least one year and more often 8 to 10 years after implantation. Any patient experiencing these or any symptoms should see their doctor for evaluation. When caught early, the disease is usually curable.


In April 2018, an Ohio woman sued Mentor Worldwide Inc. and its parent Johnson & Johnson in New Jersey state court, alleging her silicone breast implant caused her to develop BIA-ALCL. The Complaint also named J&J subsidiary, Ethicon Inc., as a defendant.

According to research published in December 2018, there have been at least 626 cases of BIA-ALCL and 17 deaths reported worldwide.

Medical concern about the condition dates back nearly a decade, however. In 2011, the FDA identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma.

In 2016, The World Health Organization recognized breast implant-associated anaplastic large cell lymphoma as a rare T-cell lymphoma that can develop following breast implants. Professional organizations including the Plastic Surgery Foundation and the National Comprehensive Cancer Network (NCCN) have published information to help physicians understand the disease and provide diagnosis and treatment.

In October 2017, a study published in the medical journal JAMA Surgery warned that many breast implant cancer cases worldwide have likely not been reported, and noted that doctors and patients may not be aware of BIA-ALCL.

Regulatory bodies outside the United States have issued communications on BIA-ALCL.

The Australian Therapeutic Goods Administration (TGA) reported a detailed analysis of the 46 confirmed cases of BIA-ALCL in Australia, including 3 deaths.

The FDA also notes in its review of the available medical literature, that all of the information to date suggests that women with breast implants have a very low but increased risk of developing BIA- ALCL compared to women who do not have breast implants. Most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation.


Since early detection is vital to effective treatment, all women offered breast prostheses should be warned of the risk of developing BIA-ALCL. They should be advised that the main symptom is swelling around the implant, often years after insertion and that they should notify their primary care team immediately if this or any of the other symptoms develop. Without a full discussion of hazards and symptoms, a patient’s consent may not be legally informed.

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Posted by
susan mrowiec
I was diagnosis Aug 18th 2015 with Anaplastic large cell lymphoma alcl neg I had textured implants had them removed due to painful swollen implant it was ruptured with a lot of discomfort and compilations. Plastic Surgeon removed them but put new implants in when she found the fluid (seroma) I had pain ever since they removed them on Nov 28th 2016. The Doctor stated there was no anaplastic capsule on my left breast . I went to Cleveland Clinic July 22nd 2016 they done four mri,s two ultra sounds on my breast said I still have the capsule in me. When I was told I had it and they where going to watch me for the next five yrs. I still have pain but they found a spot on right side now I had a mri done this March 2017 they wanted to do a biopsy but I put that on hold. I seen doctor at U of M on March 22nd 2017 he basically blew me off. I was just wondering if I have a case sometime down the road about this pain and suffering had games I been threw the past two yrs. thank you.


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