It must be soul-level certainty about never having children that leads a woman to consider sterilization. It used to be that a surgery to “get your tubes tied” was the only option. Since 2002, an device called Essure has been used to permanently block the fallopian tubes, and implantation can be done in a doctor’s office. Sperm can’t reach egg = no babies.
The coiled insert is made of “materials that include a nickel-titanium alloy”, and women allergic to nickel are warned up front and in several places across the company website. The site does a good job detailing the procedure and risks like ectopic pregnancies and hives.
But, webpage sections listing “Long-term Risks” and “Adverse Events” don’t mention that persistent or recurrent cramping can occur months or even years after the procedure. Thousands of women are saying that’s what happened to them when coils broke, migrated, or punctured the Fallopian tube.
The biggest problem is that when Essure gained FDA approval, it earned preemption status, meaning women who experience negative symptoms can’t sue the company that makes it. The actual company that makes it is pharmaceutical giant Bayer. The women want the law changed.
Enter Erin Brockovich.
The world was introduced to ballsy and boobsy Erin B. by Julia Roberts’ portrayal of her in a 2000 movie. Since Erin led and won a 1993 multimillion-dollar case against Pacific Gas and Electric Company with no formal law training (and had a movie made about her) she’s become one of the best known consumer advocates in the country.
She’s explained that her personal website was flooded with women’s stories about Essure-induced hell, detailing negative effects ranging from “debilitating headaches, nausea, allergic response to the nickel the device is made of, hysterectomies, colon perforation due to device moving, to scans that cannot even find where the device has gone.” And then there are the women who became pregnant with the device in place.
In a statement, Bayer says 750,000 women worldwide have used the Essure device, and it does more good than harm:
“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, irrespective 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. A recent practice bulletin issued by the American College of Obstetricians and Gynecologists (ACOG) has recognized that hysteroscopy 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.”
But, back to the issue of unhappy patients with no legal avenues…
Ms. Brockovich has launched a website and a Facebook page for women to share any problems they’ve had with Essure, hoping to collect 5,000 signatures that might influence lawmakers reevaluate the device’s preemption status.
“This is a law that will protect the company and if the product’s defective, the people who’ve been harmed by it basically have no recourse,” Brockovich said. “That’s not fair.”