Women Report Painful Side Effects From Birth Control
NASHVILLE, Tenn. -- Women have many options when it comes to birth control these days.
But NewsChannel 5 Investigates has found growing concern about a relatively new type, called Essure.
It's said to be more than 99 percent effective, but some say it doesn't belong on the market.
Some women who have tried it are now trying to warn others about it and they're getting some high-profile help.
After Eva Noss delivered her third daughter, she was ready for a permanent form of birth control.
"I was like, 'I'm done. I don't need any more children,'" Noss recounted to NewsChannel 5 Investigates.
Her doctor suggested Essure, a pair of coils that are inserted into a woman's fallopian tubes. Tissue then grows around the coils and seals the tubes, keeping eggs and sperm apart.
But NewsChannel 5 Investigates has found some women do experience what they describe as extreme and unbearable side effects.
"It just felt like somebody was just stabbing you in your lower abdomen, " Noss described.
Noss said her pain was chronic and totally disrupted her life.
She added, "My cramps from my menstrual cycle literally went from mild to extreme."
And Noss, we found, isn't the only one.
Consumer advocate Erin Brockovich explained, "I got involved because so many women were coming to me that had problems with Essure."
Brockovich recently started a website for women like Noss and says she's been overwhelmed by the response. She said that she's already heard from more than a thousand women who've shared similar stories of continuing and debilitating pain, headaches, and heavy bleeding they believe is caused by Essure.
"There may be something wrong with the product. So let's look at these women's story. Is it a bad product? And if it is, let's remove it," Brockovich said.
Dr. Amanda Yunker, a gynecologist at Vanderbilt, thinks Essure is safe.
"It has very few complications. It's an excellent alternative for permanent contraception when you compare it to something like laproscopic tubal ligation. " Yunker explained.
But she conceded it doesn't seem to be for everyone. Yunker specializes in pelvic pain and began looking at problems with Essure when women started coming to her with unexplained pain.
"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," Yunker said.
Dr. Yunker studied more than 450 women who had Essure put in at Vanderbilt and said she found about 4 percent or so have had continuing problems like pain, which she said is a relatively small percentage.
But Erin Brockovich believes that's still too high.
"You know 4 percent of 40,000 women is a lot of women, isn't it?" Brockovich asked rhetorically.
What really frustrates Brockovich is that when the FDA approved Essure, it gave it what's known as pre-emption status meaning women who feel they've suffered because of Essure 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. That's not fair," Brockovich told NewsChannel 5 Investigates.
Brockovich now hopes to collect 5,000 signatures from women who've had problems with Essure. They want lawmakers in Washington to take another look at the pre-emption law and the FDA to take another look at Essure.
"I think we owe that to these women. I think the company owes that to the women," she said.
Meanwhile, Dr. Yunker said laproscopic surgery she's now doing to remove Essure coils seems to be helping women with ongoing pain.
"Ninety percent plus have had relief of all or at least most of the pain," Yunker said.
The surgery worked for Eva Noss who said that her pain is gone, but the regret of trying Essure is not.
"Knowing now, definitely now, I'd never do it again," Noss said.
Bayer, the company behind Essure, sent NewsChannel 5 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 has recognized that hysteroscopic 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."
It's hard to say how many women are having these problems. Erin Brockovich believes there are many more than the thousand or so women she's heard from.
Again, Bayer reports some 750,000 women worldwide have used Essure, most of them, we're told, here in the U.S. That Vanderbilt study figures 4 percent are having problems, so potentially we're talking about as many as 30,000 women.