Essure users claim birth control device causes pain, Bayer responds
November 25, 2013 (WPVI) -- In 2002, women were given a new choice in permanent birth control.
Essure is billed as the modern alternative to women having their tubes tied.
The procedure is often done in a medical office with minimal anesthesia and recovery time.
But some women are blaming Essure after suffering a host of often undiagnosed medical conditions.
"There are some days I can't even push a vacuum; the back pain is so bad," Amanda Wooton said.
"My life slowly became crippling," Kim Bompensa said.
"I don't cry over pain, but I have been in tears over this pain," Tamara Monroe said.
All three of these women adamantly believe the crushing pelvic pain, back, and joint aches and extreme fatigue they have endured is caused by Essure's two tiny coils.
Essure takes just minutes to implant in the fallopian tubes and is less risky than traditional tubal ligation because the procedure does not require the patient to have anesthesia.
Although the Essure website states that risks immediately after the procedure include mild to moderate cramping and bleeding, these three mothers say their complications were far more severe.
"It had gone into my joints, my hip joints to the point where I couldn't walk," Bompensa said.
"Picking my daughter up, that's probably the hardest," Wooton said.
The womens' doctors told them the symptoms were not related to Essure, but multiple tests and CAT Scans offered no medical explanation for the pain.
The FDA has received 943 complaints, with pain being the top symptom.
But the agency's November 4th report concludes that "overall results from this study did not demonstrate any new safety problems or an increased incidence of problems already known."
Bayer, the company that manufactures Essure, has issued a video statement in response to the controversy surrounding the birth control.
"We are saddened to hear about any patient who has been harmed by any of our products regardless of the cause," the video says.
Bayer goes on to state that the device has been implanted in nearly 750,000 women worldwide and encourages women to discuss the risks and benefits of their birth control choice.
But a Facebook page called "Essure problems" has nearly 5,000 members.
Famed advocate Erin Brokovitch is working to get Essure taken off the market.
However, Dr. Hazem Elshoreya of Cooper University Hospital has implanted Essure in about 50 women and believes this form of birth control is both effective. He adds as with any medical device or procedure there are risks, but in the case of Essure they are small.
"Rare occasions that the coil may not be in the right place and that may cause pain," Dr. Elshoreya said.
In Kim's case, the CAT Scans show the coils were implanted correctly and never migrated, but when her doctor finally agreed to remove them, she says her symptoms disappeared.
"Within weeks, I was perfectly fine again," Bompensa said.
Dr. Elshoreya says that some women just can't tolerate the foreign object and women can experience pain as their body tries to reject it.
He added, though, that's not necessarily a problem specific to Essure.
special report, lifestyle, special reports, erin o'hearn
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