(NEW YORK) — 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 ABC News 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.
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.
According to Bayer, Essure has a well-documented benefit-risk profile, with over 400 peer-reviewed publications and abstracts supporting Essure’s safety, efficacy and cost-effect.
The summary of safety and effectiveness for Essure states that 745 women participated in a clinical study for the product. According to the summary, 2.9 percent of participants experienced perforation of the uterus and 0.5 percent experienced expulsion of the device. The study states that the most common claims were moderate pain, cramping and vomiting “during the procedure.”
The summary stated that 3.9 percent of participants experienced abdominal pain and cramps within the first year, while 9 percent reported back pain and 1.3 percent experienced gas or bloating. The summary also states that pregnancy and perforation of internal bodily structures other than the uterus and fallopian tube are all potential adverse events that weren’t observed during the study.
Essure was originally designed and manufactured by Conceptus, but pharmaceutical giant Bayer paid $1 billion to acquire the company earlier this year.
In a statement released to ABC News, Bayer’s spokeswoman Rosemarie Yancosek said that the company cares about patients and takes the safety of our products very seriously, and said that women should discuss the risks and benefits of any birth control option with their physicians.
“We are saddened to hear of any serious health condition affecting a patient using one of our products, irrespective of the cause,” she said in a statement. “No form of birth control is without risk or should be considered appropriate for every woman.”
Bayer notes in its statement that a recent practice bulletin issued by the American College of Obstetricians and Gynecologists has recognized that hysteroscopic tubal occlusion for sterilization has high efficacy and low procedure-related risk, cost and resource requirements.
Dr. Jennifer Ashton, senior health contributor for ABC News, was trained in the procedure when Essure hit the market in 2002. She says that she has opted not to perform the procedure on her patients because there are other forms of permanent birth control that are lower risk and higher benefit.
“Whenever there is the permanent placement of a foreign body — in this case, metal coils — inside the body, there is the potential for chronic pain,” Ashton said. “Because Essure does not offer any known benefit towards risk reduction of ovarian cancer, as a tubal ligation does, I feel that other forms of permanent birth control are better and safer, including male vasectomy.”
“Women considering permanent birth control should be offered all options including tubal ligation and male vasectomy, not only the procedure that a woman’s doctor is able to perform personally,” she said.
Copyright 2013 ABC News Radio