Six women have filed lawsuits against Allergan, alleging the company hid the fact its textured breast implants cause cancer risks to skyrocket.

According to the U.S. Food and Drug Administration, Allergan’s Biocell textured breast implants have been linked to an increased risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The FDA said women with the Biocell textured implants are at six times the risk of BIA-ALCL compared to the risks faced by women with textured implants from other manufacturers.

BIA-ALCL is not breast cancer, but is a cancer of the immune system that develops in the scar tissue and fluid pocket next to a breast implant. When caught early, the disease can be cured, according to the American Society of Plastic Surgeons.

The FDA is aware of 573 confirmed cases of BIA-ALCL throughout the world related to breast implants. Of those, only 26 reportedly involve smooth implants. Of those 26 patients, 12 have an unknown previous implant history, seven had previously received textured implants, and seven had previously received implants of an unknown texture. A total of 33 patients have died of BIA-ALCL.

The women allege that Allergan didn’t update warnings regarding the implants’ risks and purposefully limited information to the public by sending a private annual status update to the FDA. The lawsuits also allege that other reports neglected to use the Allergan brand name, and instead referred to the manufacturer as “Santa Barbara” and “Costa Rice” while disseminating false information.

Court documents indicate some of the women have had their breast implants removed, and some are planning to have them removed. According to their lawsuits, they blame the Allergan Biocell implants for causing them pain, disfigurement and an increased risk of suffering from BIA-ALCL.

Do Only Textured Breast Implants Cause Cancer?

The FDA is considering adding a three-prong Black Box warning to all breast implants, according to Cincinnati ABC affiliate WCPO.

A draft of the warning shows it will indicate that BIA-ALCL is more commonly found in patients who have received textured implants instead of smooth implants but that “rates are not well defined” and “some patients have died from BIA-ALCL.”

The warning also will warn women that breast implants don’t usually last a life time, and more surgeries may be needed if complications arise.

The third portion of the warning will convey that some women have reported an onset of different symptoms post-implantation, which have included joint pain, chronic fatigue, confusion, muscle aches, autoimmune disease and other health concerns.

Diana Zuckerman, president of the National Center for Health Research, started the Breast Implant Working Group that consists of patient advocates and plastic surgeons. Zuckerman hopes the FDA puts more teeth in its Black Box warning because she feels the draft is too vague.

“The FDA draft Black Box states that ‘breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).’ Association implies correlation rather than causation,” said a statement issued by the Breast Implant Working Group. “In fact, the evidence is clear that breast implants can cause BIA-ALCL.”

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