Thousands of women who had Essure sterilization coils inserted now say they regret the decision.
Over 3,000 women have started a Facebook group to offer support and information they said is not forthcoming from the manufacturer or the Food and Drug Administration.
MORE: Facebook page Essure problems
Essure was developed by the company Conceptus, and approved in 2002 after undergoing the most strenuous testing required by the FDA for "pre-market approval". Two tiny metal coils are inserted into the fallopian tubes in an outpatient procedure. The coils cause scarring within the fallopian tubes and eventual closure, preventing pregnancy.
The insertion of Essure is marketed as a lower cost alternative to tubal ligation, with fewer risks and less downtime.
"It was cheaper for me to do this because my co-pay was only $10 versus $600 (for tubal ligation)," said Sacramento resident Stephanie Bogan, who got her Essure coils four years ago. Bogan said the coil inside one of her fallopian tubes is crooked causing her near constant pain.
"I started having problems the next day. I went home and I was in pain," Stockton resident Alicia Perry added. "I called my doctor who said, 'your body just needs to get used to it.' So I took that. It's been eight years of pain."
Women got together online and shared their horror stories and experiences about Essure. The women reported that the coils broke, moved into other organs, led to accidental pregnancy, terminated pregnancy by piercing the birth sacs, caused skin rashes and led to immunity problems due to the metal materials in the coils.
The women said most doctors refuse to remove the coils unless the patient is willing to go through a hysterectomy.
"There are two facilities that offer coil removal," Marysville Essure patient Angela Lynch said. "You have to pay cash because they don't take insurance. One of them is in Cleveland and the other is in Georgia."
Lynch is one of several women organizing Essure patients online and waging a social media war against the company and the FDA.
"I cringe every single time we have another woman join the Facebook group," Lynch said.
Lynch posts new correspondences with the FDA weekly and encourages other women to post x-rays, surgical photos and post redacted hysterectomy reports from their doctors. While the social media angle has been effective, the road to legal remedy is rough.
"Once that device goes through that pre-market approval process, they (the manufacturer) are shielded from liability for harm." Medical law specialist Attorney Eric Ratinoff said. "Whether you're talking about medical devices or drugs, consumers are in a very bad position because the remedies that we've traditionally recognized for people who've been harmed by a defective product have been curtailed."
Bayer purchased the maker of Essure earlier this year and has responded to the criticism with statistics on the success rate of the coils. Rosemarie Yancosek, Bayer head of US External Communications, said the strenuous testing originally conducted on Essure stands as proof of the product's reliability.
"The US Food & Drug administration reviewed, among other things, the results from a five-year Essure study," Yancosek said. "The FDA found that although there is evidence of complications, as there are with all medical devices, overall results from this study did not demonstrate any new safety problems or an increased incidence of problems already known."
Yancosek claims that 750,000 women worldwide rely upon Essure for permanent birth control and that, "the American College of Obstetricians and Gynecologists has recognized this type of sterilization has high efficacy and low procedure-related risk, cost and resource requirements."
The thousands of women online admit it is cheaper and easier, but not necessarily healthier.
"We are responsible women who decided we were done building our family," Stockton Essure patient Amber Wyckoff said. "We are being punished for that."
The women have reached out to activist Erin Brockovich, who has started a website devoted to Essure patients unhappy with their result.
Bayer's full statement on Essure:
At Bayer, we care about patients and take the safety of our products very seriously. We are saddened to hear of any serious health condition affecting a patient using one of our products, regardless of the cause. Essure was approved by the FDA in 2002, and has a well-documented benefit-risk profile, with over 400 peer-reviewed publications and abstracts supporting Essure's safety, efficacy and cost-effectiveness. Approximately 750,000 women worldwide rely upon the Essure procedure for permanent birth control.
The US Food & Drug Administration (FDA) reviewed, among other things, the results from a five-year Essure study. The FDA found that "[a]lthough there is evidence of complications, as there are with all medical devices, overall results from this study did not demonstrate any new safety problems or an increased incidence of problems already known."
MORE: Full FDA report on Essure
In addition, a recent practice bulletin issued by the American College of Obstetricians and Gynecologists (ACOG) has recognized that hysteroscopic tubal occlusion for sterilization has high efficacy and low procedure-related risk, cost, and resource requirements.
No form of birth control is without risk or should be considered appropriate for every woman. It is important that women discuss the risks and benefits of any birth control option with their physicians.
Thank you again for allowing us to provide our commentary.
Head, U.S. External Communications