Breast Implant Illness Cancer Victims Claim Manufacturer Knew of Risks

Dozens of lawsuits have been filed against Allergan by women who claim that their breast implant illness was caused by the company’s implants and that the manufacturer knew about its textured implants’ risks but either negligently or willfully concealed it.

The women all suffer from breast implant cancer, formally known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which they allege is the result of the defendant’s Biocell saline and silicone breast implants.

Biocell Implants

The Biocell breast implants were designed with a textured outer surface, or “shell,” similar to sandpaper. Allergan offered several different models, all of which shared this feature.

The purpose of the textured surface was to prevent post-operative complications, i.e., slippage or deformation. The textured surface was designed to irritate the inner surface of the implantation site (known as the “pocket”), forming scar tissue, or a “fibrous scar capsule,” that would then hold the implant in place.

In a number of patients, the chronic inflammation resulting from this irritation led to a form of lymphoma (BIA-ALCL). In an Aug. 7 safety communication, the U.S. Food and Drug Administration (FDA) requested that Allergan recall the products voluntarily. It was noted that four of every five cases of BIA-ALCL reported around the world had been diagnosed in women who had undergone breast enhancement surgery with Allergan’s Biocell implant.

Fortune has reported that at least 36 women have died from complications related to BIA-ALCL. The true number of deaths related to Allergan implants may be even higher, as this number is only based on recent reports made to the FDA. Additionally, more than 700 women across the world have developed breast implant-related cancer. More than 2,500 women have also reported developing breast implant illness, an implant-related condition that does not cause cancer but can result in unpleasant or debilitating side effects such as joint pain, memory loss, and chronic fatigue.

About BIA-ALCL

The disease that has been identified as breast implant-associated anaplastic large cell lymphoma, known by the acronym BIA-ALCL, is a rare form of lymphoma that affects the immune system through the lymph nodes.

It’s a different condition from breast cancer, which affects the breast tissue. With BIA-ALCL, malignant cells are usually found in the fluid surrounding the implant (known in medical parlance as the seroma), or within the scar tissue of the pocket itself.

The primary symptom of BIA-ALCL is painless swelling of the breast. This typically appears between seven and eight years after the implant surgery, but according to the American Society of Plastic Surgeons, it can start in as little as two years or take as long as 28 years.

Medical science is not certain why textured breast implants cause this condition, but according to the University of Texas Southwestern Medical Center, it may have to do with the chronic inflammation that results, as well as genetic factors.

The good news is that BIA-ALCL is highly treatable if diagnosed early.

What Did Allergan Know?

What Allergan knew, and when, is the subject of several current class action lawsuits. Some plaintiffs allege Allergan has never planned to conduct post-marketing monitoring of the product.

According to a lawsuit filed against Allergan by two Florida women, the company’s decision to recall the breast implants but not pay for patients to have their implants removed has left them with a horrible choice. They claim that their options are to leave the implants in their bodies and suffer from emotional distress and anxiety about the possibility of developing cancer, or pay out of pocket to have the implants removed. Breast implant removal surgeries  can be very expensive and are often not covered by insurance. For some women, these removal surgeries may simply not be affordable.

The plaintiffs claim that the medical device company has unfairly profited at the expense of breast cancer victims who chose Allergan implants after undergoing mastectomies, in addition to breaking consumer protection laws by selling a dangerous product. The plaintiffs are seeking compensation for themselves, as well as other women who have Allergan implants and wish to remove them.

While the company has acknowledged the problem by offering a “free” replacement for patients with textured implants, or compensation for some diagnostic and surgical fees (for those choosing to keep their implants), Allergan has capped the amounts and will not pay for the removal of a defective implant.

Some plaintiffs claim that Allergan was aware of the risks of breast implant illness for several decades, but rather than reporting it to the FDA and the medical community, it continued to sell and profit from them. Defendant Allergan is accused of failure to warn, negligence and fraudulent concealment.

The current Breast Implant Illness Class Action Lawsuit is Case No. 2:19-cv-13512-MAG-APP, U.S. District Court for the Eastern District of Michigan.