Dozens of Australian women who claim to have suffered severe injuries after receiving Essure implants have joined a new class action against Bayer, arguing that the controversial medical device is inherently defective, according to The Guardian.

Australian Essure Victims Speak Out In New Class Action

Attorneys in Australia are urging women throughout the country to join the class action, which seeks to hold Bayer accountable for such injuries as chronic pain, abnormal menstrual bleeding, autoimmune disorders and device perforations.

Surgeons During Essure Operation

Currently, Bayer faces an estimated 16,000 individual personal injury lawsuits in America. In the United States, class action is generally considered an inappropriate legal mechanism for litigating cases that involve severe personal injuries.

The Australian law firm Slater and Gordon is leading the charge against Bayer in Australia, having announced the new class action on Monday, August 6, 2018.

Attorneys Highlight Nickel Poisoning Risks

Interviewed by the Guardian, Slater and Gordon associate Ebony Birchall noted the risk of nickel poisoning, saying the medical device could corrode inside the body.

According to researchers at the University of Copenhagen, the incidence of nickel allergy in the general population is high, up to 17% in women, though many of these cases remain undiagnosed. There has also been some dispute in the medical literature over whether Essure itself can cause nickel allergies.

“Essure was hailed as the new wave of contraceptive devices,” Birchall told reporters. “Unlike traditional permanent contraceptive surgery, Essure was marketed as being fast, effective and minimally invasive, it could be inserted in your doctor’s office. However, for the women who have experienced complications, it has been incredibly damaging.” As Birchall notes, complete hysterectomy is often the only way to fully remove the device’s components.

New Zealand Patients Will Have To Wait

While the class action has also drawn interest in New Zealand, attorneys, at this point, are loath to include claims from New Zealand, according to Radio New Zealand reporter Annie Marie May. May says that New Zealand’s Accident Compensation Corporation, a state-run no-fault accident insurance company, would likely complicate combining the cases.

After Global Market Withdrawal, Bayer Faces Legal Trouble

Bayer withdrew Essure from the Australian market on September 30, 2017, about a year before the device was pulled from circulation worldwide. At the time, authorities for Australia’s federal medical device agency, the Therapeutics Goods Administration, wrote that “the Australian Register of Therapeutic Goods entry will be cancelled and there will be no further implantations of Essure in Australia.”

While Bayer has consistently stated that removing Essure from the world market has been a “business” decision, related to falling demand for the device, tens of thousands of women across the globe have reported severe side effects associated with the implant, which was originally released to offer women a new option for permanent sterilization.

Nor are the two phenomena mutually-exclusive. The declining demand for Essure can largely be attributed to the public outcry surrounding the device, which has been spurred by reports of side effects and complications.

Australian Doctor Spearheaded Initial Essure Research

Essure was designed (originally by Conceptus Inc., a medical device manufacturer purchased by Bayer in 2013) to challenge the market dominance of tubal ligation, a laparoscopic procedure in which the fallopian tubes are either clipped, stitched or burned to prevent pregnancy.

Coincidentally, some of the earliest research to support Essure’s use was spearheaded by Dr. John F. Kerin, an infertility expert from Adelaide, Australia who, in 1999, referred to the medical device as “potentially one of the biggest advances in the last 30 or 40 years.” Kerin’s research was instrumental in gaining Essure worldwide acceptance as a permanent sterilization procedure.

Later Study Finds Extraordinary Risk Of Re-Operation

However, research published after Essure’s release found that, beyond being associated with numerous severe side effects, the device substantially increased the risk of re-operation.

In a study published by the British Medical Journal in 2015, researchers from Cornell University found that women who received Essure implants were about 10-times more likely to undergo subsequent fallopian tube operations than women who underwent tubal ligation. In their conclusions, the researchers estimated that use of Essure could lead to up to 21 additional re-operations per 1,000 patients, calling the device a “serious safety concern.”

Dr. John Kerin died in 2006.