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The Essure Permanent Birth Control System is made up of two metal coils that doctors place inside the fallopian tubes. Bayer claims the device is nearly 100 percent effective at preventing pregnancy. But thousands of women claim the device injured them, and it should be banned. Those same women filed lawsuits against the device’s maker.
Victims of Essure claim their health problems were ignored, and many said they felt discriminated against by doctors and the FDA. They claim Bayer failed to warn them and is guilty of negligence. For women injured by the device, turning to the legal system may be the only way to receive compensation for medical bills and lost quality of life. Many people file lawsuits because they want to prevent this product from harming others.
Kim Myers told BBC News that she was pressured by her doctor to get the device. After the procedure, she suffered severe pelvic pain for three years before getting a hysterectomy to remove the metal coils. The pain put stress on her marriage and stopped her from doing many things she enjoyed, like riding horses.
"I have never in my life felt discriminated against like I have with this whole thing with Essure," Myers told BBC. "[When I complained, my doctor] told me, 'You're a silly little woman, you're hormonal.' That's the furthest thing from the truth."
Kim Myers is not alone. Thousands of others also claim Essure caused them severe trauma, and Bayer failed to inform them of the risk. Many women who filed lawsuits did so to draw attention to the problem and prevent other women from suffering the same issues.
Tanya De La Paz filed her lawsuit against Bayer in September 2015. According to the lawsuit, in July 2012, De La Paz had her first Essure procedure. However, one of her fallopian tubes perforated during the procedure. She went to a hospital because of the bleeding. She returned again In September 2012 for a second procedure. The doctor implanted the metal coils successfully, but she suffered constant daily pain. When she returned to her doctor three months later for a follow up, the examination revealed that coil in her right fallopian tube was broken.
Bayer advised De La Paz's physician to surgically remove the right fallopian tube and the broken coil. The left coil remained implanted and continued to cause her constant daily pain and heavy bleeding. She also suffered weight gain, stomach issues and mental and emotional anguish. She scheduled surgery to remove the second metal coil in September 2015.
According to her lawsuit: "[Bayer] not only actively and fraudulently concealed adverse reports of migrations and perforations from the Plaintiff but also from the FDA."
Heather Walsh filed suit against Bayer in 2013. In 2008, she went to her doctor's office to have Essure implanted, according to her lawsuit. The doctor told her that a representative from Bayer would be there to supervise the procedure. The rep never showed, and the doctor attempted to implant the coils. The procedure failed. Walsh was forced to come back the following month and the doctor again tried several times to implant the coils without the presence of the Bayer rep. Finally, after several attempts, the inserts made it into the fallopian tubes.
After two years and four hospitalizations for severe pain, fainting and fever, she underwent a CT scan. It revealed one of the Essure coils had lodged behind her colon. There were three micro inserts and not two, as there should have been. She had to undergo a hysterectomy and an additional surgery to remove the coil in her colon. Now, she is left with a legacy of pain and autoimmune disorders. She said Bayer failed to warn her or train physicians properly.
"Defendant’s conduct was malicious, intentional, and outrageous, and constitutes a willful and wanton disregard for the rights and safety of Plaintiff and others," Walsh's lawsuit alleges.
Women may also be forced to get a hysterectomy to remove the device. This procedure comes with an entire set of new short-term and long-term risks. Short-term risks include injury to the bowel, bladder or ureters during surgery. Infection is also common and about 25 percent of women who have abdominal hysterectomies may suffer this complication. Vaginal hysterectomies carry a 10 percent risk of infection. Less common problems include fallopian tube collapse, kidney failure, heart attack and stroke.
Pain after the operation is also a problem. According to one study, 85 percent of women suffer moderate-to-severe pain after undergoing a hysterectomy. In order to manage the pain, doctors may use morphine or other injectable painkillers for severe cases in addition to over-the-counter pain pills. Many women also experience early menopause symptoms, such as depression, loss of sex drive, anxiety, hot flashes and night sweats. In some cases, women who are forced to have hysterectomies after Essure are in their twenties and must deal with the symptoms for the rest of their lives.
The long-term complications from hysterectomy may also impair a woman's quality of life. Without the uterus in place, other organs in the pelvic cavity may sag into the vagina. The function of the bladder is also affected. Women may require other dangerous procedures to treat these issues, such as transvaginal mesh implants.
Filing a lawsuit may be the only way for women to recover the cost of expensive treatments for Essure complications.
Despite the number of complaints pouring in, preemption laws protect Bayer from lawsuits. The law bars people from filing lawsuits against medical device makers because the FDA puts the device through a rigorous process before approval.
Consumer rights advocate Erin Brockovich says she is passionate about overturning the law.
"We need to hold companies accountable and in this situation Bayer can't just turn their head and go 'these 8,000 women don't matter.' I think that they have a responsibility, a duty, to take a look and, if there's a question, pull it," Brockovich told BBC. "One's too many. Eight thousand women? You cannot disregard that voice collectively. There is something wrong with the product."
Women have filed lawsuits that allege Conceptus violated the terms of the FDA's premarket approval and committed fraud by withholding data from the agency. This could mean the company forfeited its protection under the preemption laws.
The FDA held a panel discussion in September 2015 to discuss the safety and efficacy of Essure. It did not recommend banning the device, but it released additional guidelines for its use.