Some women who have a permanent birth control device called Essure say it has ravaged their reproductive systems, leaving them with scars, pain and years of unexplained symptoms.
The Essure system consists of a pair of metal coils designed to be implanted in a woman’s fallopian tubes. After several months, scar tissue that naturally builds up around the coils creates a permanent barrier to sperm, preventing pregnancy by a method similar to an intrauterine device, commonly called an IUD.
The problem, according to those who complain about Essure, is that the coils can cause pain, irritation, and much worse, long after they are implanted. However, there have been few complications reported to the Food and Drug Administration.
During a group interview with the I-Team, seven women from New York, Boston and Baltimore described complications after their Essure procedures. Some cried as they recalled years of symptoms that they did not initially connect to the coils.
“One of the coils migrated. It pierced my fallopian tube, my ureter and my bowel,” said Tina Carey, who had the Essure procedure in 2008. In addition to pain associated with the punctured organs, Carey said her symptoms include hives, kidney pain, urinary tract infections and gastrointestinal problems.
Kimberly Hock, who also had the Essure procedure, decided to have a full hysterectomy two years later, to eliminate the constant discomfort. Several other Essure patients are opting for full removal of their uteruses as well.
“My body was giving out,” Hock said. “I would have migraines at least four days a week.”
Hock believes Essure is also responsible for severe mood swings she experienced while the metal coils were blocking her fallopian tubes. She says all the symptoms went away after the hysterectomy.
Holding back tears, Crystal Donohue recounted her quest to decipher what is causing her chronic pain and lethargy.
“I’ve had four ultrasounds, a CT scan, a pelvic X-ray, I’ve been through a month of physical therapy, I’ve had injections in my hips to try to help the pain,” she said.
Finally this year Donohue visited a physician who agreed the coils may be causing the irritation.
“He looked at my record and he said ‘when can we schedule your hysterectomy?'” she said.
Essure was originally designed and manufactured by a company called Conceptus, but this year pharmaceutical giant Bayer paid $1 billion to acquire the company. Bayer declined to provide a representative to answer questions about the procedure, but the company suggested the I-Team interview Dr. Mark Levie, an OB-GYN who is a paid consultant for Essure and who has implanted hundreds of women with the coils.
Levie said complaints from women on a Facebook page warning about the risks of the procedure do not match the clinical data or his experience over a decade at his Bronx practice.
“We’ve done over a thousand procedures and we would expect if this was a really pervasive problem we’d be seeing women come in all the time with these complaints and we’re just not seeing it,” Levie said.
According to the FDA website, there have been 741 adverse events associated with Essure reported by doctors and patients since the device was approved in 2002. That compares with more than 750,000 procedures completed.
“Based on data from prospective and post-market studies of Essure, the rate of serious adverse events associated with Essure is low,” said Synim Rivers, a spokeswoman for the FDA.
But women complaining of complications question the research models relied on by the FDA.
Essure’s clinical trials were authored by doctors who were either part owners, consultants or employees of the device manufacturer. Most of their research involved two years of follow-up. Marcy Funk, a spokeswoman for Bayer, said in an email that the company has obtained five years of data on any side effects and complications experienced by 567 women who were relying on Essure for contraception.
“This information was submitted to the FDA and the adverse events reported were in line with what was initially seen in the first year of follow-up. We are in the process of publishing this information in a peer-reviewed journal,” Funk said.
Levie said Essure does have known risks, including the possibility that coils might puncture internal organs or be placed improperly. But he believes the women who complain of complications are part of a small minority and the product is safe for the vast majority of women.
“With adequate education of both the patient and the physicians, the information is all there,” Levie said.
Essure coils are partly made of nickel, but in the decade since Essure was granted FDA approval, health regulators have relaxed warnings about nickel on the product’s official packaging. In 2011, the agency allowed Conceptus to remove a contraindication for patients with known hypersensitivity to nickel as well as a recommendation for patients to undergo a skin test that might discover any unknown nickel allergy.
Many of the Essure patients who complain about chronic pain, inflammation and rashes believe the nickel is reacting with their internal organs to produce those symptoms.
“From sharing my story I met a lot of women and they were implanted knowing they had the nickel allergy and the doctors didn’t tell them,” said Melanie Goshgarian, a Boston-area native who was implanted with the coils in 2006. She had her fallopian tubes surgically removed but is still experiencing symptoms she believes are associated with a metal allergy.
Famed class-action consumer activist Erin Brockovich is now soliciting the stories of women who have had Essure complications, but federal law prevents them from suing Bayer because FDA-approved products are generally protected from liability unless there is evidence of fraud.
For Brooklyn’s Dolly Pena, Essure failed in the most basic way. Several months ago, one of the coils became dislodged and Pena became pregnant. She now fears her unborn child may be exposed to whatever is making so many women ill on the Facebook group.
“This is like a nightmare to me,” Pena said crying. “I just want to have my baby in my arms and make sure that everything is going to be OK with me and with my baby.”
According to warnings on the Essure product insert, the risks to a fetus posed by metallic coils are unknown.