January 31, 2016

Essure Contraceptive Under FDA Review After Public Outcry

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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.”

Alyson Hannan said she experienced back and pelvic pain and a rash and boils, after having Essure inserted in her fallopian tubes.

Derek Torrellas Photo.

After Essure was inserted in her fallopian tubes, Alyson Hannan said she experienced back and pelvic pain and a rash and boils.

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 the 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.

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.

Essure contraceptive.

Essure contraceptive.

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. 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 [a 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.”

 

11 thoughts on “Essure Contraceptive Under FDA Review After Public Outcry

  1. I TO have the essure and tons of symptoms. My procedure was done in an or and it lasted over an hour. I want to travel to Washington as well and would like information on how to do so

  2. I have the essure in for years. I have just about every symptom named and I have seen the doctor about it. I want it removed because of all the open wounds and pain I suffer from it. I speak to doctors and they give me the run around. I have gone without sleep but then I’m so tired I have a hard time functioning. My periods will last way longer than it should and are completely painful. I gained 50 pounds since I had it. I see people staring at my legs and they ask what happened to them. The scars that I have are so bad I don’t want to wear shorts. It’s pathetic that this has been going on for so long. I want to tell every woman please please understand how this has caused such a problem. I would tell them get a tubal before getting this procedure. There are doctors who that do the procedure that would not have this done to them. WHAT DOES THAT SAY.

  3. I also was harmed by essure, took three and a half years away from me. I had B. some of the same problems pelvic pain, lower back pains shooting down my legs, covered in hives from head to toe on and off for two years, boils, dizziness, fatigue to the point where I had to actually pull myself out of bed, my teeth just Break in half! Had a hystorectomy leaving ovaries in October and I’m doing so much better except my teeth this has been aweful!!

  4. I too had the essure done and have had severe abdominal pain, back pain, and fatigue. I went to the ER a few weeks ago for really bad stomach pain, they told me everything looked fine but I had a cycst on my ovaries that ruptured, so the fluid is why I was in so much pain. It is these coils I had inserted in me in 2014 and my body hasn’t been the same since!

  5. I had Essure October 2010. I had hair less, pelvis pain, two periods a months. April 2015 had a miscarriage and a hysterectomy in July 2015. The Essure moved too my uterus.

  6. I’m just happy to see this! All this time I and doctors plus emergency room doctors cannot find why my symptoms and I never knew my essure was the culprit! My Gynecologist has always denied any possibility that they were side effects of the essure because she put it in. I get it, but i need my life back

  7. I had the essure done in 2008. Three years later in 2011, too much scar tissue built up inside of me causing me to hemorrhage. I almost died. I was in the hospital for two days and had to get a blood transfusion. I had a DNC done to get all of the excess scar tissue out of me. I asked the Dr what caused me to do this and she told me she didn’t know. I asked if it happened because of the essure and was told no. What a big lie!! I know that it was the essure. Today I have chronic fatigue, dizziness, anxiety attacks, headaches, and still have scar tissue that occasionally comes out of me and drops into the toilet. I want these devices out of me now!

  8. I got Essure implanted in 2007 in my Doctor’s office. Right side went in and it was painful but the left side was harder to implant so Dr. had to shove it in all while I am screaming for her to STOP because it was the worst pain I have ever felt, the whole procedure took 45 minutes by the end I was dry heaving and saying I was dizzy and thought I was going to faint, I was left in the room with my friend whom would care for me. less than 30 days later I would end up in the Emergency Room from severe pelvic pain and heavy bleeding. I thought I was having a miscarriage but was told it was my essure. I would suffer for 5 years and no one could figure out why…I was left to believe I was going crazy. until exactly to the day at the 5 year mark I started having dizziness that would not go away my stomach blew up huge, and severe left sided pelvic pain, migraine that would not go away and then I had my STROKE! I now cannot find a Doctor willing to help me remove this essure because there not sure what damage has been done to me internally…Please help me I want this out of me before it kills me..

  9. I want to find out more options about how to get this removed I have experienced almost all of these side effects and if made my life miserable anyone please share and information with me

  10. I’ve had essure for 5 years I’ve had all the complications that has been said and still do no Dr where I live will take them out and I also don’t have the money just health insurance I would like to have them taken out removed my body hurts all the time everyday some days I don’t even get outta bed only long enough to get my son ready for school I can’t work due to not being able to stand for very long or sitting so please if anyone noes of someone to help get them removed please let me know.

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