Women around the country gathered together on Saturday, May 6, 2017 to hold a series of rallies against German conglomerate Bayer and its birth control implant Essure.
Essure Protests Held Across The Country
From Houston and Raleigh to San Diego and Jacksonville, hundreds of patients joined forces in front of city halls and federal courthouses to protest the continued manufacture and sale of a medical device that thousands of women say causes horrendous side effects.
Their protest was spurred by the latest meeting of the American College of Obstetricians and Gynecologists, the nation’s premier membership organization for reproductive health specialists. Joined by family members and friend, dozens of Essure patients converged outside the San Diego Convention Center, where the obstetricians and gynecologists met from May 6th to May 9th.
“Ban Essure” was their united message, emblazoned on colorful signs and amplified by the raised voices of women from coast to coast. Simultaneous protests were held in Berkeley, California, Dallas and Kansas City, Missouri. Supporters assembled in Meridian, Idaho and Dayton, Little Rock and Denver.
ACOG Supports Essure In Absence Of Other Options
While tens of thousands of women have experienced horrific side effects after receiving the implants, the US Food & Drug Administration has yet to remove the implants from the market.
The American College of Obstetricians and Gynecologists (ACOG) continues to recognize Essure as a viable “treatment option” for women unable to undergo more traditional tubal ligation procedures. The organization’s website, in an overview of “hysteroscopic sterilization,” places little emphasis on the device’s potential side effects, noting only ectopic pregnancies and injuries sustained during the actual implantation procedure. “In rare cases,” ACOG says, “women report pain that does not go away.” Other problems, like “bleeding and spotting,” are said to last for one week after implantation.
Thousands of women would disagree with the organization’s characterizations. Abnormal menstruation, for example, is among the most frequently-cited side effects of Essure. Many women say the symptoms only resolve after the implants have been removed. Removal options are limited, though. In many cases, an invasive hysterectomy, in which the uterus is surgically removed, is the only sure-fire method for relieving the device’s symptoms.
Group Questions Boxed Warning, Patient Decision Checklist
The American College of Obstetricians and Gynecologists has also taken a controversial position on regulatory action, raising the ire of activists around the country. In fact, ACOG has come out to criticize recent measures intended to increase patient awareness of Essure-related complications, including the “decision checklist” meant to be read, discussed and signed prior to implantation. As Modern Healthcare reports, the experts at ACOG were “worried” that the patient decision checklist could dissuade qualified patients from pursuing Essure as their contraceptive choice.
The consortium of practitioners also resisted the “black box warning” now affixed to every Essure implant sold in the United States, arguing that the warning’s language had been based on “anecdotal evidence,” not clinical study data.
The American College of Obstetricians and Gynecologists suggested revising the warning text, but said the patient decision checklist should be “abandoned” entirely. There’s little doubt that ACOG’s official position on Essure has raised the ire of women’s health advocates and patients across the country.
Long-Term Data Is On The Way
Reported Essure side effects run the gamut, from chronic pelvic pain, the most common alleged complication, to autoimmune disorders. Lori Rutter, who shared her experiences with an FDA review panel in 2015, says the birth control implant aggravated a pre-existing condition: multiple sclerosis.
Thus far, Food & Drug Administration researchers have focused much of their public attention on Essure’s short-term effects, noting symptoms like cramping, nausea and back discomfort, that can arise immediately after the device is implanted. This focus on early complications isn’t terribly surprising, though. While Essure was approved in 2002, the controversy over the implant’s safety is far more recent. In any event, the meaning of “long-term” takes a different tenor, considering that the device is intended for permanent use. More research, however, is coming. Bayer is currently spear-heading a seven-year study to investigate the contraceptive implant’s complications in 2,800 women.[/fusion_text]