Essure is a “permanent” birth control option for women: two small, flexible metal implants that block the fallopian tubes, preventing the release of eggs into the uterus. When it was approved in 2002, Essure was expected to sweep the market. Finally, women had been a given a safe, effective method of sterilization that was both cheaper and far quicker than tubal ligation.
Thousands Report Severe Side Effects With Essure
But there’s a problem. Thousands of women say the Essure implants can migrate or break inside their bodies, causing excruciating pain and numerous serious complications. Many of those patients have gone straight to the US Food & Drug Administration, voluntarily filing severe adverse event reports. In fact, the FDA has received more than 5,000 of these reports since Essure’s release on the market, a New York Times investigation found.
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Worldwide, more than 750,000 women have received Essure implants. Bayer, however, still won’t provide a number for how many American women have been implanted. That makes properly judging the device’s risks and benefits extremely difficult.
Essure Can Migrate, Break & Cause Severe Pain
Numerous women have reported severe pain, specifically abdominal pain. Many have experienced abnormally heavy, or irregular, menstruation, while others have suffered from chronic headaches, crippling fatigue and troubling weight fluctuations.
Doctors have noticed a problem, too. In their own reports, physicians have noted a high incidence of “patient – device incompatibility.” While the link isn’t yet clear, some researchers speculate that the nickel titanium alloy used to make Essure is causing allergic reactions in some patients. In September 2015, one medical expert who took part in the FDA’s panel review of Essure complaints, told the New York Times with outrage: “How can Bayer and the F.D.A. have no knowledge of nickel allergies?”
Device migration is another major concern, with more than 450 doctors identifying women in whom the Essure implant slipped out of the Fallopian tube. That’s incredibly dangerous, since the device’s pointed ends can perforate uterine walls or other internal organs. It’s possible that many of the women who have experienced extreme pain after receiving the implants have device migration to blame. Reports of device breakage are also prevalent, and tragically, some women have been forced to undergo hysterectomy to prevent further damage to their bodies.
16 Possible Side Effects Linked To Essure
According to patients, Essure’s side effects run the gamut, from chronic abdominal pain to autoimmune problems like lupus and celiac disease. Here are 16 of the most common complications reported by current and former Essure patients:
- chronic pelvic pain
- severe dysmenorrhea (menstrual cramps)
- serious infections
- uterine and intestinal perforations
- ectopic pregnancy
- excessive abnormal bleeding
- prolonged menstruation
- abnormal vaginal discharge
- vaginal infections
- pain during intercourse (dyspareunia)
- hair loss
- weight fluctuation
Did Bayer Lie About Essure?
Essure may cause numerous severe side effects. But even more troubling are allegations that the device’s manufacturer has been concealing that fact for years.
In one of a handful of lawsuits filed against the company, Plaintiff Heather Walsh claims a 2013 FDA investigation uncovered more than 16,000 side effect reports that had never been reported to the Agency. The complaints, found in an Excel spreadsheet on Bayer’s internal servers, included reports of device migration.
Walsh says she received the Essure implants, only to find that one of the coils had migrated from her Fallopian tube to her uterus and rectum. After five hospitalizations, Walsh says she was forced to undergo a hysterectomy.
Is Essure As Effective As We Were Told?
Some critics, including the grassroots women’s health advocates at EssureProblems.com, say the implant’s effectiveness as a contraceptive “has been over-rated.” The support group, founded and run by current and former Essure patients, claims that hundreds of women have become pregnant after being “sterilized” with the implants.
Ectopic pregnancies, true medical emergencies in which a fertilized egg implants inside the Fallopian tube, have been linked to Essure, too.
One unintended pregnancy proved particularly embarrassing for Essure’s former owner, small-time medical device manufacturer Conceptus Inc. After raving about the ease of receiving Essure implants, Olympic skier Picabo Street found herself unexpectedly pregnant. Conceptus, which had taken Street on as the device’s public face, promptly removed any mention of the athlete from its website.
In its series of investigative reports, the New York Times spoke with at least one medical researcher who was willing to call Essure’s efficacy into question. Dr. Aileen Gariepy, an assistant professor at Yale’s School of Medicine, says her calculations show that up to 1 in every 10 women with Essure will get pregnant over the course of 10 years, a far higher number than in those who undergo tubal ligation, the standard form of permanent sterilization.