Hundreds of women file complaints over contraceptive.
It's billed as a 10-minute procedure. No surgery required. No down time.
What's not to like about this permanent form of birth control? Plenty, according to hundreds of women who have filed complaints with the Food and Drug Administration.
It's called Essure. It uses two metal coils the size of spaghetti noodles, and they're inserted into the Fallopian tubes to block conception.
Kim Hudak of Lakewood is among the hundreds of women in Northeast Ohio and across the country who say the coils have made their lives a living hell.
Hudak says she was forced to undergo a hysterectomy to remove the coils due to all the complications she believes they were causing.
"I had no quality of life. I had blackout periods. I was always in pain," she said. But nine days after she had the coils removed, she says she's never felt better.
"This is amazing. I'm so glad to have my life back," she said.
Hudak participated in the clinical trials for Essure at the Cleveland Clinic in 2000. She says she was unimpressed -- and notes that the study's doctors failed to listen to her complaints regarding a number of symptoms.
"I don't think they followed me closely enough," she said.
Hudak says doctors never suggested that Essure might be the cause of her unexplained pain, or that she might be allergic to the nickel in the coils.
Melissa Turner complained to the Investigator Tom Meyer that she felt as though a needle was sticking into her female parts.
"I was in horrible pain," she said. Turner also opted to have the coils surgically removed this month.
Much to her surprise, she became pregnant with Essure. The manufacturer says it is 99.83 percent effective.
"This was not supposed to happen, but I did miscarry," she said.
Amanda Lama had three children when she opted for permanent birth control -- or so she thought.
The Stark County woman had her fourth child with Essure.
"It was awful for me at first. I was devastated," she said, but added, " I love her to death, and I'd never give her back."
A company called Conceptus developed and manufactured Essure, but Bayer, the large pharmaceutical company, acquired the company this year.
In a written statement, Bayer said:
"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."
"If this was a pervasive problem, you'd be seeing women coming in all the time with complaints and we're just not seeing it," said Dr. Mark Levie, a paid consultant for Essure. His office has performed about 1,000 Essure procedures.
Since 2002, the Food and Drug Administration has received 943 complaints from women about Essure. Women complain of extreme pain, bloating, fatigue, cramping and rashes, among many other complications.
The most frequently reported adverse events were pain (606), hemorrhage (140), headaches (130), menstrual irregularities (95), fatigue (88) and weight fluctuations (77).
The most frequent device problems were migration of the device or its components (116), patient device incompatibility, such as a possible nickel allergy (113), the device operating differently than expected (73), malposition of the device (46) and device breakage (37).
(To view complaints, see www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM.)
The FDA acknowledges there are complications from Essure but said they're nothing out of the ordinary.
Still, the FDA called Essure an effective sterilization choice for women. The agency has no plans to remove it from the market and promises to continue monitoring complaints and symptoms.
By law, victims are not allowed to sue the manufacturer of Essure or any FDA-approved medical device.
But victims haven't given up their fight to try to get the law repealed.
They have a famous consumer advocate on their side. Erin Brockovich has launched a Web site --www.brockovich.com/projects/essure-procedure -- that encourages women to share their Essure stories.
Brockovich believes Essure should be removed from the market.