The U.S. Food and Drug Administration (FDA) has confirmed that breast implants may cause a rare type of non-Hodgkin lymphoma called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and there have been hundreds of reports of this disease associated with saline and silicone breast implants, including at least nine patient deaths. Unfortunately, in many of the cases of BIA-ALCL that have been reported to federal regulators, the cancer was diagnosed years after the initial implant surgery, which means women who have had breast implants for years may still be at risk for non-Hodgkin lymphoma side effects. If you have been diagnosed with anaplastic large cell lymphoma, and you believe your breast implants to be the cause, contact our consumer advocates at the Consumer Justice Foundation today. We are dedicated to protecting the rights of consumers harmed by allegedly defective medical products, and can help put you in touch with an attorney who has experience handling breast implant lymphoma cases.
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is not cancer of the breast tissue; rather, it’s a rare type of non-Hodgkin lymphoma involving cells of the immune system that can develop around breast implants. When women receive breast implants, the implants are inserted behind the breast tissue or under the chest muscle, and over time, a fibrous scar, called a “capsule,” develops around the implant, separating it from the rest of the breast. In women with breast implant-associated anaplastic large cell lymphoma, the ALCL is typically found adjacent to the implant, and contained within the fibrous capsule. At this time, it is believed that breast implant-associated anaplastic large cell lymphoma occurs more frequently with breast implants that have textured surfaces, compared to those with smooth surfaces.
Most women with breast implant-associated anaplastic large cell lymphoma were diagnosed when they sought medical attention for symptoms like pain, swelling, lumps or asymmetry, occurring after the initial implant surgical sites were healed. According to the FDA, these symptoms were the result of masses surrounding the breast implant, a collection of fluid (persistent seroma), or a hardening of the breast area around the implant (capsular contracture), and an examination of the fluid and capsule surrounding the implant is what led to the BIA-ALCL diagnosis. In general, the diagnosis of breast implant-associated anaplastic large cell lymphoma has been made after a woman noticed changes in the look or feel of the area surrounding the breast implant. Some possible symptoms of BIA-ALCL include:
It was back in 2011, that the FDA first identified a possible association between breast implants and anaplastic large cell lymphoma, but there were so few cases of the disease that the agency was unable to determine what specific factors increased the risk of ALCL. At the time, the FDA had identified 34 unique cases of ALCL in women with breast implants, after reviewing scientific literature published from January 1997 to May 2010. In the years since, the FDA has gathered additional information in an effort to better understand the development of ALCL in women with breast implants, and the agency now agrees with the World Health Organization’s designation of breast implant-associated anaplastic large cell lymphoma as a “rare T-cell lymphoma that can develop following breast implants.”
According to reports, textured breast implants appear to pose a higher risk of ALCL than smooth implants, and this is believed to be due to the fact that, while all breast implants can be contaminated with bacteria during surgery, the immune system may have a more difficult time fighting bacteria that can hide in the creases of a textured-surface implant. This can result in a low-level infection or chronic inflammation possibly leading to lymphoma, a cancer that starts in the white blood cells that fight infections. As of February 2017, the FDA has received a total of 359 adverse event reports associated with BIA-ALCL, including nine deaths. Unfortunately, due to a lack of global implant sales data, and significant limitations in worldwide reporting of BIA-ALCL, it is likely that cases of breast implant-associated anaplastic large cell lymphoma are underreported.
Product liability lawyers across the country are investigating claims of anaplastic large cell lymphoma allegedly associated with breast implants, and lawsuits brought against the manufacturers of silicone and saline breast implants will likely all involve similar allegations that the companies failed to warn women about the potential for their implants to cause non-Hodgkin lymphoma. Women and the families of women diagnosed with BIA-ALCL may file legal claims alleging that, had they known about the potential for breast implants to cause anaplastic large cell lymphoma, they could have avoided developing the disease by choosing different breast implants, or by foregoing implants altogether.
January 2011 – The FDA releases a statement indicating that women with breast implants “may have a very small but increased risk of developing” anaplastic large cell lymphoma “in the scar capsule adjacent to the implant.”
May 2016 – The World Health Organization recognizes breast implant-associated anaplastic large cell lymphoma as a rare T-cell lymphoma that women can develop after receiving breast implants.
2016 – The Plastic Surgery Foundation and the National Comprehensive Cancer Network (NCCN) publish information designed to help physicians understand breast implant-associated anaplastic large cell lymphoma and provide appropriate diagnosis and treatment.
June 2016 – The French National Agency for Medicines and Health Products Safety (ANSM) requests that manufacturers of textured breast implants perform biocompatibility testing to determine how living tissues react to textured-surface breast implants.
December 2016 – The Australian Therapeutic Goods Administration (TGA) provides a detailed analysis of the 46 confirmed cases of BIA-ALCL in Australia, including three deaths, and estimates the risk of developing the disease to be between 1-in-1,000 and 1-in-10,000 women with breast implants.
January 2017 – The journal Plastic and Reconstructive Surgery publishes a study reviewing federal database submissions related to BIA-ALCL in 37 countries, and finds 258 unique cases of the disease as of September 2015, including five deaths.
February 2017 – The FDA indicates that it has received a total of 359 medical device reports involving BIA-ALCL, including nine deaths. Of the 231 reports that included data on surface information, 203 involved textured implants and 28 involved smooth implants.
March 2017 – In an update of the FDA’s BIA-ALCL warning, the agency reports that its understanding of breast implant-associated anaplastic large cell lymphoma coincides with the WHO designation of the disease as a “rare T-cell lymphoma that can develop following breast implants.”
The potential risk of ALCL associated with breast implants has been evident for at least six years, since the FDA issued its first warning in 2011, and the agency has identified hundreds of cases of anaplastic large cell lymphoma tied to silicone and saline breast implants, including at least nine patient deaths, occurring during this time. Lawsuits brought against the manufacturers of breast implants may accuse the companies of:
Worldwide, an estimated five million to 10 million women have breast implants, and the FDA recommends that people with breast implants regularly monitor their implants for any changes, and schedule routine screenings, like MRIs or mammograms, as recommended by their doctors. For women diagnosed with breast implant-associated anaplastic large cell lymphoma, and the families of women who have died from the disease, financial compensation may be available for past and future medical expenses, pain and suffering, lost wages and wrongful death, which they can pursue by filing a breast implant lymphoma lawsuit against the implant manufacturing company. If you or a loved one has been diagnosed with BIA-ALCL, contact our consumer advocates at Consumer Justice Foundation today, to speak to qualified product liability lawyer about your case.