Erin Brockovich, whose fight against an electric company became a Julia Roberts movie, has taken up a new cause. Now 53, the famed consumer advocate has started a grassroots campaign against the Essure birth control procedure, which she wants investigated and taken off the market.
"There's something wrong with the device, in my opinion," Brockovich told ABCNews.com. "It's a form of permanent birth control, and women's organs are being perforated … It's ridiculous that at any level we try to defend this. If 30 women did suffer harm for unknown reason, we'd investigate. We have thousands injured. I don't think it's safe."
Bayer owns Essure, which is billed as a nonsurgical alternative to tubal ligation -- known colloquially as having one's "tubes tied." Approved by the Food and Drug Administration in 2002, the Essure device is a pair of coils inserted into a woman's Fallopian tubes. The coils prompt the growth of scar tissue around the tubes to seal them.
According to ABC, of the 700,000 women who have undergone the procedure, 800 have filed complaints with the FDA.
Brockovich said that the FDA gave Essure "preemption" status, which means that women who want to sue the company, can't do so.
"If someone had a medical device installed, there's no recourse for victims, and the company is protected," she said. "If there's a problem, the company gets a pass, because they have preemption. It dawned on me the consumer didn't know. The women didn't know that this existed."
Tanya Lovis told CBS Miami that she started to experience persistent cramping and pain in her abdominal region when she realized it might be related to her Essure implantation.
“They said you’ll have a little bit of cramping afterwards and you can go back to work tomorrow. Clearly these things did something to me and I knew it,” Lovis said.
"My cramping gradually progressed, and it kept getting worse. It's like having a daily period, like you're preparing for labor -- the contractions of labor pains," another Essure patient told ABC News. "Any physical movement would make the cramping worse."
"We care about patients and take the safety of our products very seriously," Bayer said in a statement. "We are saddened to hear of any serious health condition affecting a patient using one of our products, irrespective of the cause."
The statement continues:
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.
While gynecologist Dr. Amanda Yunker told CBS Miami that she used Essure as an "excellent alternative" to tubal ligation, she acknowledged that a "small subset" of patients experience pain.
