- (Photo: Reuters/Larry Downing)
Erin Brockovich, the consumer activist famous for her multi-million dollar lawsuit against Pacific Gas and Electric Co. in 1993, has launched a campaign against a popular form of birth control that she says is unsafe for women.
Brockovich has launched a website and petition against the Essure procedure, a permanent birth control procedure that involves small, bendable coils made out of nickel being inserted into the patient's fallopian tubes. Scar tissue forms around the coils and seals the tubes. The outpatient procedure has been approved by the Federal Drug Administration and championed as a cost-effective method to other permanent birth control procedures, such as tubal ligation.
Brockovich writes on her campaign's website that she has been "amazed" at the amount of stories she has heard from women negatively affected by the procedure, suffering anything from headaches due to a reaction to the coils' nickel composition, or intense abdominal cramps and back pains due to the device moving and puncturing the uterine wall.
The well-known activist goes on to write that none of the women she has spoken to were told of these possible serious side effects due to the Essure implant. "It is a woman's right to decide for herself if she wants a certain form of birth control but when they are NOT [sic] told of the devastating side effects, well that isn't right," Brockovich writes.
"We hope that together we can find comfort, create awareness around this issue, help those who are having problems and create a movement to get this product off the market and find a remedy for those who have been harmed," she added.
Brockovich added to ABC News that she believes there is something wrong with the Essure device. "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."
CBS interviewed one woman living in Ventura, Calif., Tanya Lovis, who says she suffered major cramping and heavy bleeding following her Essure procedure in 2011; she researched complaints online and found 1,800 women on Facebook who had had similar problems. Ultimately, Lovis decided to have a full hysterectomy that removed the coils, and her pain stopped immediately.
The Essure implant was originally designed and manufactured by Conceptus, but then acquired by Bayer earlier this year for a $1 billion price tag. Essure's summary of safety and side effects indicates that out of 745 women tested in a clinical study, 2.9 percent of the patients experienced perforation of the uterus, 3.9 percent experienced abdominal pain and cramps, and 9 percent experienced back pain.
Bayer's spokeswoman Rosemarie Yancosek released a statement to ABC News saying they are "saddened" to hear of the complaints caused by Essure, but continue to stand by its safety claims.
"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 added.
The pharmaceutical company added that 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."