Erin Brockovich Leads Fight Against Birth Control Procedure Essure
Oct. 10, 2013 — -- A popular and permanent form of birth control that hundreds of women say is causing severe adverse reactions has now become the latest cause of famed consumer advocate Erin Brockovich, who has launched a grassroots campaign against the procedure.
Brockovich, who in 1993 led a multimillion-dollar groundwater contamination case against Pacific Gas and Electric Co., has launched a campaign to have the Essure procedure taken off the market of birth control options. Brockovich told ABCNews.com that she first heard of the product about a year ago, and after hearing an increasing number of horror stories launched the campaign and online petition for women to share their stories about Essure, inform each other and initiate change.
"There's something wrong with the device, in my opinion," Brockovich said. "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."
Brockovich said she has no financial stake in the outcome of this campaign.
Essure is a non-surgical transcervical sterilization procedure that was approved by the Food and Drug Administration in 2002, and is meant as a cheaper, easier and safer alternative to tubal ligation.
During the outpatient procedure, bendable coils are placed into the fallopian tubes, passed from the vagina through the cervix and uterus. Scar tissue then forms around the coils and blocks the tubes from insemination, according to marketing literature provided by the manufacturer.
Brockovich is calling for Essure to be taken off of the market by Bayer, who owns Essure, and is seeking a complete investigation into injury claims.
"[Bayer] should care about the health and welfare of all people," she said. "Especially women and children in this country. If this many are reporting injuries, take it off the market. It's not working. These women were misled. They feel they were scammed."
Brockovich also points to the fight against so-called contentious preemption laws, which exempt product manufacturers from tort claims for products that the FDA has approved. When the FDA approved Essure in 2002, it gave the device preemption status.
"Preemption is not about the Essure women – it affects all consumers," she said. "If someone had a medical device installed, there's no recourse for victims, and the company is protected. 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."
More than 700,000 women have undergone the procedure, according to Conceptus, which originally designed and manufactured Essure. Over 800 women have filed adverse event reports with the FDA about Essure birth control since 2004, according to the FDA website. In August, a woman who was admitted to the hospital with abdominal pain after having the Essure procedure died from streptococcal toxic shock syndrome, though the attending physician ruled that the cause of death was not directly related to the Essure inserts or procedure.
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In addition to Brockovich's site, a number of groups have popped up on social media dedicated to sharing experiences with Essure. The unverified reports include claims of extreme abdominal pain, excess bleeding, rashes and bloating, to having to have internal organs removed.
Joleen Fuller told ABCNews.com that she decided to have the Essure procedure after having her fourth child. Though she was initially wary, she decided after some research and speaking with her obstetrician to go ahead with the outpatient procedure, mainly because it was touted to have minimal downtime and would fit into her busy schedule. But the decision, she said, ended up being a major mistake, and her ordeal began almost immediately after the procedure in April 2012.
"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," she said. "Any physical movement would make the cramping worse. I couldn't clean, I couldn't play with the kids, and I couldn't lose my baby weight. Stress made the pain worse. It was unbearable."
According to Fuller, she was born with two uteruses -- a condition she said that her doctor was aware of – and was told by doctors after the procedure that everything was fine, even though she was in extreme pain. One doctor even wiggled an Essure coil in her face and told her that something so small couldn't be causing her pain, she said.
