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Potential product liability lawsuits are being evaluated against the manufacturers of certain types of breast implants, which have been linked reports of a rare form of cancer, known as breast implant anaplastic large cell lymphoma (ALCL), which is a subtype of non-Hodgkin’s lymphoma.
STATUS OF BREAST IMPLANT CANCER LAWSUITS: Lawyers provide free consultations and case evaluations for women diagnosed with anaplastic large cell lyphoma (ALCL) or other forms of breast implant cancer, which may be diagnosed years after breast augmentation or reconstructive breast surgery.
MANUFACTURERS: Allergen Inc., Mentor Corp. and others
OVERVIEW: The first breast augmentation surgery was conducted in 1962, involving a silicone breast implant. Since then, there have been questions regarding the safety and potential side effects of breast implants, including both silicone and saline implants.
Early concerns involved the risk of silicone breast implant ruptures, resulting in the removal of silicone implants from the market in 1992. They were reintroduced in 2006, after no health risks were found specifically involving silicone implants.
However, in 1997 the first case of anaplastic large cell lymphoma (ALCL) was linked to the use of a breast implant. Since then, researchers worldwide have detected dozens of cases of ALCL associated with both silicone and saline implants, resulting in a number of recent warnings from the World Health Organization, the FDA, and Australian health regulators.
All of the warnings acknowledge the risk of what is now known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which it appears may be related to textured breast implants. This breast implant cancer may surface anywhere from a few years to nearly 30 years after surgery.
A study published in October 2017 warns that reports of BIA-ALCL are likely to increase in coming months and years. Another study published at the beginning of 2018 warned that textured breast implants increased the risk of ALCL by more than 400 times.
A special report on medical devices published in late 2018 indicated that manufacturers and regulators may have known of the cancer risks, but failed to provide adequate warning to women.
In March 2019, the FDA revealed that it receives tens of thousands of breast implant adverse event reports every year.
In April 2019, all textured breast implants were banned in France, and Allergan’s Biocell breast implant was banned in Canada. French investigators also made special note of the number of cases linked to the Allergan Biocell model.
In July 2019, the FDA issued an Allergan Biocell breast implant recall, indicating nearly all cases of BIA-ALCL have been linked to that specific design. The company then removed the entire brand from the global market.
In December 2019, all federal Allergan Biocell breast implant lawsuits were consolidated before one judge for pretrial proceedings in New Jersey as part of a multi-district litigation (MDL).
Several studies, including one from February 2021, have found that removal of Allergan’s Biocell breast implants, appears to be the best way to treat BIA-ALCL.
BREAST IMPLANT LYMPHOMA: The rare form of non-Hodgkins lymphoma linked to breast implants, known as anaplastic large cell lymphoma (ALCL), occurs in the fluid surrounding the implant.
It is not a form of breast cancer, however, it can spread to the lymph nodes in some cases and has been linked a growing number of problems worldwide.
It is likely that many breast implant cancer cases have gone unreported, since most doctors remain unaware of the issue. In addition, mammograms are not useful in detecting this form of cancer, which can be found using an ultrasound and subsequent testing of fluid around the breast implant.
The FDA first issued a warning about the potential breast implant lymphoma risk in January 2011. However, at that time the agency could not confirm that the cases of ALCL in women’s breasts were definitively associated with their breast implants.
A number of studies conducted in recent years suggest a potential causal link between breast implants and ALCL cases. As a result, risk risk of breast implant-associated ALCL (BIA-ALCL) was recognized by the World Health Organization (WHO) in 2016. A number of physician groups and other countries have also issued warnings.
In March 2017, the FDA concurred with the WHO designation, indicating that at least nine deaths from breast implant ALCL have occurred in the U.S. The agency warned that the cases appeared to have a strong association with the use of textured breast implants. A year later, in March 2018, the agency reported that it had identified 400 cases of breast implant cancer.
Research has indicated that, in most cases, removing the implant cures the problem. However, in some cases it can cause solid lumps to form, resulting in the need for more traditional means of cancer treatment, such as chemotherapy.
If left undetected, the cancer can spread to the lymph nodes and can cause death.
In a warning issued by the Australian Therapeutic Goods Administration in April 2017, the risk of breast implant-ALCL was estimate to be between 1-in-1,000 and 1-in-10,000 women who have received breast augmentation or reconstructive breast surgery.
A study published by Australian researchers in May 2017 found that textured breast implants were 10 to 14 times more likely to cause BIA-ALCL than non-textured implants, with researchers determining that the higher total surface area of textured breast implants was linked to a higher risk of cancer diagnosis.
Data suggests that most cases develop between three and 14 years after a woman receives the implant. However, some cases have emerged in as little as one year after implantation, or as late as 37 years.
BREAST IMPLANT CANCER CLASS ACTION LAWSUITS: As a result of the manufacturers’ failure to thoroughly research the effects of breast implants on live tissue, which has already resulted in one past recall, and their failure to warn women about the potential risks, financial compensation may be available through a breast implant cancer lawsuit.
If warnings and information about the risk of anaplastic large cell lymphoma (ALCL) from breast implants had been provided, many women may not have chosen to undergo the procedure, and some breast implant cancer cases may have been avoided.