MIAMI (CBSMiami) — There’s a growing number of complaints about a popular form of birth control that some say is causing serious health problems. Now, consumer advocate Erin Brochovich says Congress needs to get involved.
For months, Tanya Lovis suffered with mysterious pain. The mother of two said the symptoms were so severe she could barely tolerate doing even basic things.
“I was literally walking around hunched over holding onto my stomach,” said Tanya. For ten months doctors couldn’t figure out what was wrong. Tanya started researching online and found that she wasn’t alone.
“And that’s when I put two and two together,” said Tanya.
Women also started reaching out to activist Erin Brockovich.
“Let’s look at these women’s story,” said Brockovich.
The stories are concerns about a permanent form of contraception called Essure. Essure claims to be more effective than having Fallopian tubes tied. A pair of coils is 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,” said Tanya. She was eventually told she needed radical surgery.
Brockovich said she heard similar complaints from other women.
“So I started a website and was actually very overwhelmed how quickly it built from 50 to a couple hundred to now thousands of stories of women,” said Brochovich. She said when the FDA approved Essure; it gave the product what’s known as a preemption status, meaning women who feel they’ve suffered because of Essure cannot sue Bayer, the parent company of Essure.
“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. That’s not fair,” said Brockovich. She hopes to collect five thousand signatures on her website from women who’ve had problems with Essure. She wants lawmakers in Washington to take another look at the pre-emption.
Bayer says Essure was approved by the FDA in 2002, and is used by 750,000 women worldwide. The company also says Essure has a well-documented benefit-risk profile, with over 400 peer-reviewed publications and abstracts supporting Essure’s safety, efficacy and cost-effectiveness.
Gynecologist Dr. Amanda Yunker 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.
However, while she hasn’t heard of many complication, she acknowledged it’s not for everyone.
“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,” said Dr. Yunker.
After a full hysterectomy, which included removing Essure coils, Tanya said her pain has disappeared.
“Oh, I feel amazing. I feel like a new woman. I feel like they’ve replaced my body with another woman’s body,” said Tanya.
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.”
For more information, visit the links below:
Birth Control Information- http://womenshealth.gov/publications/our-publications/fact-sheet/birth-control-methods.cfm
Essure Information- http://www.essure.com/
Erin Brockovich- http://www.brockovich.com/