Breast Implant Associated BIA-ALCL Cancer Lawsuit Information

Washington, DC: Individuals with breast implants are at risk of developing a type of cancer called breast implant associated with anaplastic large cell lymphoma, known as BIA-ALCL, which was first identified over 20 years ago. Most current data suggest that BIA-ALCL occurs following implantation of breast implants with textured surfaces rather than those with smooth surfaces.

An FDA report (updated March 22, 2019) emphasizes that BIA-ALCL is a type of non-Hodgkin’s lymphoma (cancer of the immune system) and not breast cancer. The agency first identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL) in 2011.

In line with the World Health Association (WHO) guidance, the FDA in 2016 designated breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare but highly treatable T-cell lymphoma that can develop following breast implants. WHO states that both saline- and silicone-filled implants have been implicated in the risk of developing BIA-ALCL.

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. When detected early, removing the implant and the capsule of scar tissue that forms around the implant can usually cure ALCL. But some women have needed more extensive treatment than surgery, including chemotherapy and radiation, and the disease can be fatal.
  Despite the FDA associating breast implants with this form of cancer back in 2011, manufacturers have no plans to cease production of implants in question, according to a NBC News report (March 19, 2019).

On March 18, the FDA issued two warning letters to implant manufacturers Sientra Inc and Johnson & Johnson citing their failure to do proper safety studies and failing to comply with the post-approval study requirements for their breast implants. Reuters reported that the letter to J&J’s Mentor Worldwide LLC noted “several serious deficiencies” in the company’s post-approval study for its MemoryShape breast implant approved in 2013. Identified violations include
 

• Failure to enroll the required number of patients in the study
• Data inconsistencies
• Poor patient accounting
• Missing race and ethnicity data

Sientra had reported a poor patient follow-up rate of 61 percent for the post-approval study of its silicone gel breast implants, which required the company to evaluate the study subjects annually for 10 years, according to the FDA letter.

Reuters also reports that in 2018, the U.S. Securities and Exchange Commission sued Sientra’s former chief executive for fraudulently concealing problems with his company’s breast and other implants while raising $61.4 million in a public stock offering.

If these manufacturers fail to make good the violations, the premarket approval granted to the products may be withdrawn.
  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.
  Doctors have diagnosed 457 women in the U.S. with BIA-ALCL and 17 women worldwide have died with the disease.

In early April 2019, France’s National Agency for Safety of Medicines and Health Products banned Allergan’s textured breast implants, specifically macro-textured and polyurethane implants, and cautioned doctors and patients about using other brands of textured implants.

Health Canada (April 5) “advised” Allergan that it intends to suspend the licences for Biocell breast implants as a precautionary measure. Health Canada reports that 28 confirmed Canadian cases of BIA-ALCL — 24, or 86 percent were linked to Biocell breast implant.

And regulators in the Netherlands also temporarily suspended macro-textured and polyurethane implants.

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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Last updated on Mar-23-22