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Complaints mount over contraceptive device; lawsuits tricky

The NBC Charlotte I-team has found complaints are mounting against a common medical device used by three-quarters of a million women for contraception.
The NBC Charlotte I-team has found complaints are mounting against a common medical device used by three-quarters of a million women for contraception.

CHARLOTTE, N.C. -- The NBC Charlotte I-team has found complaints are mounting against a common medical device used by three-quarters of a million women for contraception.

The women included say the device called Essure caused debilitating pain, bleeding-- even punctured tissue.

But a federal law makes it almost impossible for victims to sue.

One of those women was Kayla Blankenship, of China Grove, North Carolina. Her second labor and delivery almost killed her.

"I almost bled to death having my baby," she said.

So Kayla turned to a medical device called Essure, two tiny metal coils inserted into the fallopian tubes, to make sure she never got pregnant again.

"They told me there were no symptoms besides mild cramping afterwards," Blankenship said.

But once the coils were placed in her body, she says, "I started feeling stabbing pain, excessive bleeding, hot flashes for a long period of time."

She had one surgery to take out the metal coils, but even after that she had more symptoms.

"Allergic reaction-- hives all over, my lips swelled up and symptoms just got worse and worse," she said.

But when Kayla complained to her doctor, she says, "She actually laughed at me and said there was no possible way; everything was out of there."

But she says a scan turned up another problem.

"They found a fragment embedded in my uterus," she said.

Then she had a hysterectomy at age 23.

Now, she wants Essure banned.

"As of right now there are way too many problems with it," Blankenship said.

And through a Facebook page called "Essure Problems", with more than 12,0000 followers, Kayla found out she wasn't alone.

"I started feeling really intense pain right where your ovaries would be," said Lisa Knox, of Charlotte, who we met through an active online community of women who compare their experiences with Essure.

"I had to go to three gynecologists before I found one that took me seriously and did the surgery," said Knox.

A Personal Choice Tubal Reversal Center in Raleigh has taken the Essure metal coils out of 150 women.

Dr. Charles Monteith at the center says he still believes Essure works for many women, but he has heard from some women who felt their doctors misled them about the potential side effects and downplayed their complaints.

Many of the women who had prolonged and painful reactions to the device believe they should be able to sue the makers of Essure, a company called Conceptus, which was bought this year by Bayer HealthCare.

"I just think they need to take responsibility for the pain it's caused to the women and their families," said Knox.

But veteran Charlotte trial attorney Gary Jackson says he would not take such a lawsuit.

He says the first lawsuit over Essure, filed this summer in Philadelphia, faces long odds against winning.

"To do that you would have to show the physicians are not trained sufficiently by the manufacturer to implant the device or that the manufacturer actually broke federal law," Jackson said.

That's because Congress passed a medical device amendment. It says since medical devices like Essure won premarket approval from the FDA, the law bars common law claims, and the Supreme Court has upheld that law.

"It's so sad that all these women have experienced all this pain," Knox said.

Bayer has issued printed and video statements on the risks and benefits of Essure.

The company revised those risks to say, "There are rare reports of chronic pelvic pain among women who have had Essure."

"We are saddened when we hear of any problems," Bayer HealthCare Dr. Edio Zampaglione said in a videotaped statement. "Essure is one of the most effective contraceptives and has been on the market for over 10 years."

The FDA approved Essure after a study of 500 women.

"Five hundred women is not a big group, so I don't think that's going to give you the kind of adequate data to determine the kinds of things that can go wrong," said Dr. Octavia Cannon, an obstetrician and gynecologist at Arboretum OB GYN in Charlotte.

Dr. Cannon thinks Essure should still be an option for women who are done having children, but only after weighing all the risks and options.

"If you were my sister, I want you to go for a second opinion," Dr. Cannon said. "If it's something major, I'm never offended by that-- an informed patient is the best patient."

The online community of women who call themselves E-sisters are waging a public education campaign.

"I don't want any other women to suffer-- not one," said Knox. "I want them to be educated and know what they're going into because it was a nightmare."

Essure has been used by three quarters of a million women all over the world, so Bayer emphasizes that complaints come from a small percentage of women.

But the complaints to the FDA are serious.

So if you or someone you love is considering Essure as contraception, it's helpful to read a variety of sources.




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