February 20, 2020
Breast implant safety called into question
Safety concerns related to breast implants are unfortunately not new. Health-related side effects have plagued breast augmentation implants since their appearance on the U.S. market in the early 1960s.
A new safety concern is particularly significant. It appears that textured breast implants may cause breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare form of non-Hodgkin’s lymphoma. In 2016, the World Health Organization officially classified BIA-ALCL as a type of T-cell lymphoma caused by breast implants. This and other recent scientific evidence establishing an alleged link between textured breast implants and large cell lymphoma has re-opened the debate about the safety of breast augmentation implants. It’s a debate the FDA appears to be taking seriously considering it compelled breast implant manufacturer Allergan to voluntarily recall its Biocell® textured implants and tissue expanders in July 2019.
The alleged connection between BIA-ALCL and the Biocell textured implants lies within the specific design and manufacture of the Biocell line. Modern breast implant devices, first used in the 1960s, had thick outer shells to prevent rupture. An unintended side effect of that design, however, was that thick scar tissue grew around the implant. This scar tissue caused significant pain and aesthetic problems. To remedy this, breast implant manufacturers in the 1970s began texturizing the breast implants’ surface to prevent uniform scar tissue from forming.
Simply put, texturizing was intended to ensure tissue grew into the irregular spaces of the implant’s shell and to prevent excess collagen and fibrous tissue from forming. Manufacturers create the irregular spaces on the implant surfaces using various techniques. For the Biocell implants that were recalled in July, Allergan created the “texture” by dipping the silicone implant capsule into salt crystals before it dried. Then, Allergan washed and cured the capsule surface, which left behind a pitted surface with randomly sized pores.
Unfortunately, this new innovation brought with it unintended consequences. The texturizing process left unwanted, and unneeded, silicone particulates and other fragments from the manufacturing process on the implants’ surface. Because these foreign objects were not removed from the implants before they implants were placed in women’s bodies, it seems in some women they triggered an inflammatory process around the implants, called a foreign body reaction. Over time, this inflammation can lead to potentially serious negative health effects, like BIA-ALCL.
BIA-ALCL is not breast cancer, instead, it is a type of cancer targeting the immune system. It is rare for a disease to be named after the product that caused it, but BIA-ALCL is only found in people with textured breast implants. In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant. When the FDA announced Allergan’s voluntary recall in July 2019, there were 573 confirmed cases of BIA-ALCL worldwide, and in the United States, approximately 91% of those cases were diagnosed in women with Allergan implants.
The true scope and impact of BIA-ALCL is largely unknown due to “significant limitations” in worldwide reporting related to the disease and a lack of sales data, according to the FDA. Tracking of BIA-ALCL cases is largely limited to patient registries maintained by only a few academic centers that are dependent on patient referrals, reports show. If you or a loved one was diagnosed with BIA-ALCL, consider reporting your diagnosis and other health complications to the FDA because the agency continues to study the potential dangers of textured breast implants. If you have not been diagnosed but want to know what type of implant you received, you can also contact your implant surgeon or your insurance company, and then discuss with your doctor your personal medical situation to determine if you should take any additional steps related to your implants. For more information on BIA-ALCL, visit the FDA online.
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