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Monday, February 1, 2016

How Many Adverse Events Does It Take to Get Bayer Essure Recalled By FDA? MORE !!!$$$???

Birth-control device under FDA review

By Maryellen Fillo, Conn. Health I-Team Writer | February 1, 2016 (FiDA highlight)

Alyson Hannan, of Farmington, is among the women who have had problems after having the Essure birth-control device implanted.

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 Sept. 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. Rep. 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. Rep Rosa DeLauro, a Democrat from Connecticut’s 3rd Congressional District, that 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 inadequate 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, approved by the FDA in 2002 for women ages 21 to 45, is a flexible coil that is inserted into each fallopian tube in a doctor’s office. Essure is made of nickel titanium alloy and a polyester-like fiber called polyethylene terephthalate, or PET. The procedure, performed in a doctor’s office, takes about 10 minutes. The medical device was originally manufactured by Conceptus, which was purchased by Bayer HealthCare in 2014. Once inserted by an OB-GYN, scar tissue forms around it, blocking the tubes and preventing eggs from being fertilized.
Varying experiences
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.

In response to the public outcry, Dr. Dario Mirski, Bayer’s vice president and head of U.S. medical affairs, said, “Bayer’s highest priority is patient safety, and we sympathize greatly with any woman who has experienced problems with Essure.”
“We continue to be committed to maintaining an open dialogue with any patient who has questions or concerns about Essure,” Mirski said in a press release.
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 Feb. 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.”
Dr. Russell Turk of the Stamford Health Medical Group said, “Overall I feel it is good but I have had a couple of things occur but nothing bad.”
“As with any form of contraception, there are always benefits and risks,” Turk said, whose office is in the Riverside section of Greenwich.
Turk said he does the outpatient procedure in Stamford Hospital’s Tully Health Center, rather than his office.
“I don't like the idea of fishing around in a uterus in an office setting,” said Turk, noting some bigger medical groups might have more sophisticated equipment.
He said he goes to the center because “sometimes there can be problems with the insertion and if that happens we have other options like a laparoscopic tubal and are in a safe setting with the right equipment and can proceed.”
At first, Turk said he instructed his patients who wanted the Essure device to have a nickel allergy test but was advised it wasn’t necessary. He said he has never had a patient who suffered any allergic reaction to the device.
“I do ask patients if they have a nickel allergy or if they think they might,” Turk said.
Turk said his patients have requested Essure and he offers it.
“I don’t think anyone feels there is never a possibility of something going wrong,” he said. “There is no perfect form of contraception other than abstinence.”
‘E-Sisters’ ranks grow
Dr. Odie Kuiper, an OB-GYN in Avon, said he has used Essure nearly 200 times with no reported problems, but is very careful to review risks with his patients.
“I understand the request for (FDA) review, because no one wants anything that is not safe for a patient,” he said. “But I don’t think the adverse effects are common enough to take the device off the market.”
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.
Angie Firmalino, another founder of the Facebook group, said the goal is to get the device off the market.
“We plan to continue to garner for support of the ‘E-Free Act,’ ” said Firmalino, of New York. “We suspect the FDA report will call for minimal requirements for the manufacturer to change labeling and such. We need Congress to act and revoke the pre-market approval of Essure so that the civil rights of women harmed by Essure can be restored.”
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’s doctor, Jennifer Grant, who is in practice at the Women’s Comprehensive Health Center and on the staff of Hartford Hospital, will perform the hysterectomy. She said that she has used the Essure device for over eight years, and that Hannan is the only one to report a problem.
“I am very curious to see if her symptoms improve after it is removed,” 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.”
This story was reported under a partnership with the Connecticut Health I-Team (

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