Thousands of women have reported severe side effects after being implanted with Essure, a medical device used for permanent female sterilization. While the implant’s manufacturer, Bayer Pharmaceutical, “stands by” Essure’s risk-benefit profile, according to AOL News, government regulators have taken widespread calls for a recall more seriously.
At FDA Panel, E-Sisters Stand Up For Women’s Health
Nearly 14 years after the device’s initial approval, the US Food & Drug Administration decided to reevaluate Essure’s potential risks, convening a meeting of its Obstetrics and Gynecology Devices Panel on September 24, 2015.
While the panel’s 19 experts served as the meeting’s focal point, the agenda made room for an “open and transparent dialogue” between all “stakeholders,” including patients and the public. Bayer itself was well-represented, with 8 presenters in attendance, including the company’s vice president of US Medical Affairs and 2 corporate “advisors” from Johns Hopkins University.
During the panel’s public hearing session, which was open to women affected by Essure, 22 patients spoke passionately of “severe pain[,] heavy bleeding” and the numerous other side effects they experienced after receiving the implants.
Many of the women represent a growing movement based at EssureProblems.com, which has been remarkable not only for its size but the real impact it’s had on policy-makers and regulatory officials. The women, who call themselves E-Sisters, have garnered high-profile support from the likes of Erin Brockovich, the legal clerk who famously brought down an energy company for polluting a California town’s drinking water.
Patient Draws Link Between Essure, Autoimmune Disorders
One woman, Lori Rutter, told the panel her complications were so severe that she “had to use a wheelchair.” Rutter, who has Multiple Sclerosis, drew a link between her underlying autoimmune disease, the Essure implants and her worsening symptoms, saying: “bottom line, this is an inflammatory device that is worsening and creating autoimmune disease and cancer at the expense of women and families everywhere.”
22 women have added their own personal stories, describing a potential link between Essure and autoimmune disorders like fibromyalgia and MS, to Brockovich’s website: EssureProcedure.net. While few studies have been conducted to investigate the association, you can hear Bayer’s vice president of US Medical Affairs, Dr. Edio Zampaglione, appear to admit that Essure causes autoimmune disorders in this interview with an ABC News affiliate. The doctor’s subsequent comment, that “we’re talking much less than 0.1%” of patients, has been widely criticized as down-playing the significance such an association would have on patients’ lives.
Severe Pain Leads To Hysterectomy
Another patient, Krystal Donahue, spoke of the long, difficult ordeal she went through to have the implants removed. Noting that she was “not an extreme case,” Donahue said she had suffered through “abdominal pain,” pain during intercourse and “extreme fatigue” after receiving the device.
It took 2 years, and over 20 doctor’s visits, to finally determine that the cause of her side effects might be Essure. Donahue underwent a hysterectomy on her “37th birthday,” she told the panel, before thanking her doctors “for freeing [her] from the pain Essure caused.” As for the FDA and Bayer, Donahue could only say: “[you] are simply failing us.” Her emotional testimony was met by applause, according to the meeting’s official transcript.
“There’s Nothing Wrong With” You
Elena Melendez, an ER nurse and mother of two, described “pelvic pain, bladder pain, pressure and painful intercourse” after receiving the implants in February of 2008. Melendez lives with a nickel sensitivity, and while the Essure implants contain nickel, she was assured by her doctor that it wouldn’t be an “issue,” since “Essure was not made of the same nickel that was in costume jewelry,” a metal her body had rejected on several occasions.
But soon after the implantation procedure, Melendez began experiencing side effects. Multiple sonograms, she says, returned normal results, and she was repeatedly told that Essure’s small, flexible “coils were within normal limits.” Over and over, she was told that Essure “had no side effects,” the implants couldn’t move, and worst of all, there was nothing wrong with her. In reality, Melendez was suffering. Pain became her “norm,” damaging her life at home and at work.
It was only when Melendez turned to outside help, receiving CAT scans from a different doctor, that she learned the truth. Her Essure implants had moved. The left coil had slipped almost entirely out of her Fallopian tube. The right coil was “buried in [her] endometrial cavity.” A swift removal procedure was ordered, but the nurse says she continues to live with “adrenal and kidney issues,” along with “memories of the woman, mother, and nurse [she] was before [she] had Essure implanted.”
Those are just three stories out of tens of thousands. Whether or not these women’s voices were heard by the FDA is still in doubt. The agency has said it will issue a final ruling on Essure’s safety sometime this month, February 2016.