Breast augmentation with breast implants is not an uncommon procedure in the western world. There are many types of implants on the market. One of those types, textured breast implants, was recalled because they can cause a rare type of Cancer called “Breast Implant-Associated Anaplastic Large Cell Lymphoma” (BIA-ALCL).
BIA-ALCL is not breast cancer. It’s cancer affecting the immune system. Textured implants have a sandpaper-like rough surface that makes them adhere to the surrounding tissue. This adherence prevents them from moving and repositioning within the implant pocket. Textured implants are often used due to minimal risks of scarring (reducing capsular contracture), And because they hold their position better than other types of implants, and give a more natural-looking teardrop appearance.
What is BIA-ALCL?
BIA-ALCL is a type of Non-Hodgkin’s Lymphoma affecting T cells, and is very rare. This type of lymphoma is associated with synthetic breast implants, more specifically textured implants. So, women who have or had textured breast implants in the past are at risk of developing BIA-ALCL. It is commonly localized and develops in the scar tissue capsule and the fluid around the implant. However, it can spread throughout the body in some cases if not diagnosed and treated promptly.
These symptoms sometimes don’t develop until many years after the breast implants are implanted (7 to 10 years later). Common symptoms include pain, lump, or swelling around the implant area, while some may also experience a skin rash, fever, enlarged lymph nodes, and weight loss. If diagnosed timely, most of the cases are treated successfully by removing the implant and surrounding affected scar tissue. In some patients after surgery, chemo and radiotherapy are also needed.
When was BIA-ALCL First Identified?
The first case of BIA-ALCL was reported in 1997, and fourteen years later, in 2011, the FDA reported the possible correlation between breast implants and ALCL. Later in 2016, BIC-ALCL gained recognition by the World Health Organization. Until then, the researches have shown it to be linked with the textured breast implants. Since that time, FDA has taken several steps to look into the link between the incidence of BIA-ALCL with textured implants. A Dutch study published in January 2018 showed the following estimated risk of ALCL in women with breast implants.
* 1 in 35000 at 50 years of age.
* 1 in 12000 at 7 years of age.
* 1 in 700 at 75 years of age.
However, this risk is higher with textured implants.
Recall of Textured Breast Implant by Allergan
Allergan pharmaceutical company announced a global recall of its Biocell textured breast implants on the request of FDA on July 24, 2019. The FDA requested the recall because of an increased incidence of BIA-ALCL with patients that have these implants. According to the report by FDA, 573 cases of BIA-ALCL were diagnosed worldwide, and 481 of them had Allergan textured implants.
33 women died due to lymphoma, and 12 of those dead women had Allergan implants. The FDA said that the risk of getting BIA-ALCL from Allergan textured implants is six times higher than the textured implants from other manufacturers. Textured implants represent 10% of all the breast implants sold in the USA. The higher risk of BIA-ALCL with textured implants is not fully known, but it is believed that due to its rough surface, they are more prone to bacterial invasion. This invasion then leads to an inflammatory response that activates the immune system. More studies are currently ongoing to try to understand the exact mechanism of why these implants cause this rare cancer.
The FDA requested that Allergan “voluntarily” recall its BIOCELL® textured breast implants and tissue expanders because they cause an increased risk of patients developing this rare cancer. If you have these implants, and are experiencing any of the symptoms listed in this article, call and speak to an attorney today: (800)961-1909.
Questions and Answers about Breast Implant-Associated Anaplastic Large Cell fda Lymphoma (BIA-ALCL): https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl
References
- https://www.breastcancer.org/treatment/surgery/reconstruction/types/implants/special-report/anaplastic-large-cell-lymphoma
