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Schachter, Hendy & Johnson, Attorneys At Law

Essure Contraceptive Under FDA Review After Public Outcry

Posted on Feb 02, 2016

When Alyson Hannan, 44, decided she was done having children, she chose Essure, a non-surgical permanent birth control option approved by the Food and Drug Administration. The day the tiny metal coils were inserted into her fallopian tubes in her doctor’s office is one that she can’t forget, said Hannan, regional sales director for Met Life who underwent the procedure on September 11, 2014. “I will never forget that date. None of us will.”

Hannan is among tens of thousands of women, now referred to as “E-Sisters,” who have banded together on Facebook to share their stories of adverse health problems, including allergic reactions, chronic pelvic pain, device migration, hair loss, and headaches.

Their public clout and a citizens’ petition prompted the FDA to launch a review of Essure, and U.S. Representative Mike Fitzpatrick (R-Pa.) to sponsor legislation calling on the FDA to withdraw its approval for use. The controversy will come to a head in February, when the FDA is expected to complete its review, and when members of the “Essure Problems” Facebook group are heading to Washington to lobby Congressional members to support Fitzpatrick’s “E-Free Act.”

The concerns over Essure have been fueled by a January report by a federal watchdog agency, conducted at the request of U.S. Representative Rosa DeLauro, a Democrat from the 3rd Congressional District, which faulted the FDA for failing to adequately track and disclose safety concerns that arise after drugs go on the market. Inspectors from the Government Accountability Office expressed particular concern about the lack of tracking of products cleared under two expedited approval programs. The lack of adequate pre-marketing and post-marketing studies of Essure was highlighted in a recent article in the New England Journal of Medicine that was co-authored by Yale University School of Medicine researchers.

DeLauro was among the first members of Congress to speak out against Essure, writing to the FDA in October to say she was “deeply disturbed by reports from women about severe adverse health effects they have suffered…” and calling on the agency to withdraw Essure from the market. Essure is a flexible coil that is inserted into each fallopian tube in a doctor’s office. The procedure, performed in a doctor’s office, takes about 10 minutes. Once inserted by an OB-GYN, scar tissue forms around it, blocking the tubes and preventing eggs from being fertilized. An estimated 750,000 women have received Essure. Warnings on the product include side effects such as mild cramping, vaginal bleeding and some temporary discomfort.

The FDA has received 5,093 medical device adverse reports on Essure, a majority of them citing abdominal pain, irregularities in menstrual cycles, fatigue and possible nickel allergy. Some women have reported perforation of the uterus and/or fallopian tubes or intra-abdominal or pelvic device migration. Four adult deaths and five fetal deaths were also reported, according to the FDA. In September, the FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee met to discuss the risks and benefits of Essure and received over 2,800 written public comments. The FDA said that it expects to complete its review by the end of February.

In the meantime, members of the “Essure Problems” Facebook group are heading to Washington on February 2 to speak to Congressional members to garner support for Fitzpatrick’s “E-Free Act.”

In Connecticut, doctor’s opinions on the device vary. Dr. Henry Jacobs, an OB-GYN and president of the Connecticut State Medical Society, said he used Essure when it was first introduced, but does not generally use it now, opting instead for tubal ligation, another permanent sterilization procedure. “There were too many factors that made me say, ‘Hey, I can do this another way’,” Jacobs said. “I think Essure is worthy of a review.”

 Angela Desa-Lynch of California, one of the founders of “E-Sisters,” doesn’t want to leave the decision up to the FDA. “In 2011, when we started the page, we had just 130 women -- at a time when the horrible side effects of the implant were not well publicized, and everything was all gumdrops and candy canes,” she said. “Now we are over 25,000 members, and our mission is to save other women from what we have been through.” Desa-Lynch, the mother of two sons and a daughter, had a hysterectomy to remove the coils after it was determined she was allergic to the materials used in the device. “I lost my hair, my teeth and felt like I always had the flu,” she said. “It changed my life, and I don’t want my daughter to ever have it as an option. I don’t ever want her to have the opportunity to choose Essure,” she added.

Hannan, of Farmington, has coped with years of severe backache and pelvic pain; long, heavy periods; insomnia; fatigue; weight gain; and a rash and boils that covered her body. She’s missed work, her children’s activities and other social events because of the way she feels and looks. “It has been a nightmare,” said Hannan, who is scheduled for a hysterectomy in early February to remove the coils. “I don’t think the doctor had any reason to not believe it was safe until it was too late,” she said. Hannan is convinced that once the device is removed, her health will improve. But her longer-term mission is to protect other women from the device. “I honestly feel the product was fast-tracked due to money, and in the quest to make money, they ignored what happened to 25,000 women,” she said. “I just want it out of me. I just want to be well again.”

If you or a loved one suffered tubal/uterus puncturing, bleeding, or other injuries from Essure, please call our experienced products liability attorneys at (888) 606-5297 for a free consultation about your Essure lawsuit.

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