SIMI VALLEY (CBSLA.com) — A Ventura County mother of two says a permanent contraception device called Essure has caused her and thousands of other women excruciating pain.
“I was literally walking around hunched over holding onto my stomach for three weeks out of the month,” Tanya Lovis said. “The pain was just too much to bear.”
For 10 months, doctors were mystified by Lovis’ symptoms: “…excruciating pelvic pain, sharp stabbing pains in my left and right side, I started bleeding very heavily and I would literally vomit from the spinning sensation.”
“My body was telling me something was wrong,” the mother said.
Lovis began researching online and discovered approximately 1,800 women on Facebook who also had opted for Essure and were experiencing similar symptoms.
Back in December 2011, Lovis decided she didn’t want any more children and visited Planned Parenthood to discuss permanent contraception. They offered her Essure, which claims to be less invasive and more effective than having the Fallopian tubes tied.
A pair of coils are inserted into a woman’s Fallopian tubes, prompting tissue to grow around the coils and seal the tubes. Essure does not require surgery.
“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.
A different doctor recently performed a pelvic exam on Lovis and told her radical surgery was needed. After a full hysterectomy, which included the Essure coils, Lovis says all her painful symptoms have disappeared.
“Oh, I feel amazing. I feel like a new woman. I feel like they’ve replaced my body with another woman’s body,” Lovis said.
Consumer advocate Erin Brockovich says the amount of emails she’s received about Essure have raised a red flag.
“I started a website and was actually very overwhelmed how quickly it built from 50 to a couple 100 to now thousands of stories of women throughout the United States, and by the way in Europe as well, who were experiencing the same problems,” Brockovich said.
Dr. Amanda Yunker, a gynecologist at Vanderbilt University, thinks Essure is safe.
“It has very few complications. It’s an excellent alternative for permanent contraception when you compare it to something like laparoscopic tubal ligation,” said Yunker, who specializes in pelvic pain.
Bayer, the parent company of Essure, says 750,000 women worldwide have used the device but Yunker acknowledges it’s not for everyone.
“And then when I started taking them out and found that their pain resolved, then we realized that, yes, Essure can cause pain in a small subset of patients,” the gynecologist said.
Brockovich said she’s frustrated that when the Food and Drug Administration approved Essure in 2002, it gave what’s known as preemption status, meaning women who experience negative symptoms can’t sue the company that makes it.
“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.”
Brockovich is trying to collect 5,000 signatures on her website from women who’ve had problems with Essure, hoping it will make lawmakers reevaluate the device’s preemption status.
Bayer says Essure has been reviewed favorably in hundreds of publications. The company issued the following statement:
“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.”