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Group wants popular birth control device removed from market

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Group wants popular birth control device removed from market

By Darcy Spears. CREATED Nov 7, 2013

Las Vegas, NV (KTNV) -- It's supposed to prevent unwanted pregnancy, but at what cost to a woman's health? Thousands of women across the country are reporting serious side effects and severe pain after using a popular birth control device called Essure.

A group of local women told Action News their bodies are being jeopardized and they've got nowhere else to turn.

"I went and saw all these doctors. It consumed my life," said Jenny Taffel, who had the procedure in 2010.

Indi Kaufman had Essure implanted in 2011, "I had to go through so much for it finally to be discovered what was wrong."

Victoria Jones and Idalia Duenes were also in our group interview.

"Nobody understood the pain I was going through daily," explained Kaufman.

The four women in the group share similar symptoms.

"Having to have migraines," said Duenes. "Having to have severe back pain. Pelvic pain."

"My stomach started protruding abnormally," recalled Taffel.

Each of the patients told Contact 13 they put up with the symptoms for years after having the birth control device Essure placed in their bodies. But their doctors were not making a connection between the problems and Essure.

"It's unbearable some days. But you got to keep pushing for your children. You can't let them hear you say, 'I'm in too much pain to play with you right now.' So you just go through it," said Jones.

Essure was approved by the Food and Drug Administration in 2002. It is a flexible coil inserted into the Fallopian tubes. In about three months, scar tissue develops around the coil, creating a barrier between sperm and eggs. It's the only non-surgical sterilization choice for women who want permanent birth control.

Essure's brochure describes the procedure as surgery-free, hormone-free, anesthesia-free and worry-free.

Darcy Spears asked the group of women how the procedure was presented to them, "Was this a matter of trusting your doctor for all of you? Nobody raised any red flags? Gave you any warnings? This was supposed to be easy as pie?"

The entire group agreed with, "Yes."

For Jones, who had Essure implants in 2010, regrets her decision, "I have to lay down in the middle of cooking dinner because I'm in so much pain."

Taffel tried for years to figure out what was wrong with her, "Your body's taken over. It's like you don't own your own body anymore."

She went back to her doctor and was referred to a gastroenterologist. Eventually she got an ultrasound, "That's when they found that my coil had migrated into my uterus and cervix."

She ended up having a hysterectomy.

Kaufman had a similar experience. She eventually had surgery to take the coils out, "The doctor told me it was perforating my intestines and my bowels. So that's why I was having the tremendous pain that I was having daily."

Adverse event reports filed with the USDA, document 116 instances of the coils dislodging and ending up where they're not supposed to be.

When Darcy asked, "There's no doubt in your mind that what you went through was directly a result of this device?" Tafel answered, "No. No doubt."

According to the FDA, there have been some 750,000 Essure procedures performed worldwide. Though it's considered high risk, they believe the benefits outweigh the risks.

From 2002 through October 2013, the FDA has received 943 adverse event reports related to Essure. They range from pain, hemorrhage and headache, to miscarriages, internal injuries and hospitalizations. Click here to search the reports yourself.

Many women are speaking out and joining forces over their Essure experiences.

One Facebook group, Essure Problems, started in 2012 and now has more than 3,000 members who call themselves "e-sisters."

The women in our group from the Las Vegas Valley are sharing their stories in hopes other women will be better informed. They also want to see Essure removed from the market.

They also said they are frustrated and feel few in the medial profession are listening.

When Contact 13 asked for a statement from the FDA, they sent a written statement:

The FDA conducted a search of the Manufacturer and User Facility Device Experience (MAUDE) database. From Nov. 4, 2002, Essure’s approval date, through Oct. 25, 2013, the FDA received 943 reports of adverse events related to Essure. The most frequently reported adverse events were pain (606), hemorrhage (140), headache (130), menstrual irregularities (95), fatigue (88), and weight fluctuations (77). The most frequent device problems reported were the migration of the device or device component (116), patient device incompatibility (113) (e.g., possible nickel allergy), device operating differently than expected (73), malposition of the device (46), and device breakage (37).

(Note: Adverse event reports are submitted to the FDA by medical device manufacturers, importers, health care facilities, health care professionals and patients. These reports are used to monitor marketed medical devices, and may contribute to the detection of potential device-related safety issues as well as to the benefit-risk assessments of these devices. While the reports are a valuable source of information, this passive surveillance system has notable limitations, including the potential submission of incomplete or inaccurate data, under-reporting of events, lack of denominator data (number of implants), inability to demonstrate causal relationship between the device and complaint, and the lack of report timeliness.)

The FDA has reviewed Essure patient reports of problems (including web-based testimonials) and adverse event reports submitted to the FDA from a variety of sources, including doctors, patients, and the manufacturer of Essure, Conceptus, Inc. The agency also reviewed the results from a five-year follow-up post-approval study conducted by Conceptus that was required by the FDA as part of the product’s 2002 approval. In addition, the FDA evaluated the available clinical literature to determine what long-term complications may be associated with Essure. To date, there is no literature reviewed by the FDA that has indicated any new or more widespread complications definitely associated with Essure occurring more than five years after Essure placement. (Because the FDA had up to five year follow-up data from the post-approval study, the literature review concentrated on evaluating long-term complications more than five years after placement.)

We take reports of problems with Essure very seriously and will continue to review them carefully. Since approval in 2002, there have been some 750,000 procedures performed worldwide. No form of birth control is 100 percent effective and scientific evidence reviewed by the FDA shows that Essure is a highly effective means of sterilization when used according to instructions. Essure is the only non-surgical sterilization choice for women who want permanent birth control. Although there is evidence of complications, as there are with all medical devices, overall results from this study did not demonstrate any news safety problems or an increase incidence of problems already known. We will continue to monitor the safety of this product to make certain its benefits of providing women with a non-surgical sterilization choice continue to outweigh the risks of the device.

It is important for women to work with their health care provider to have a thorough evaluation and receive the proper follow-up. The FDA strongly encourages individuals to submit a voluntary report about any problems you have experienced with Essure through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. The FDA reviews the MedWatch reports and takes any necessary action to protect public health. 

For more information: click here.

--Food and Drug Administration

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Bayer HealthCare Pharmaceuticals manufactures Essure. They also provided a statement:

At Bayer, we care about patients and take the safety of our products very seriously. We are saddened to hear of any serious health condition affecting a patient using one of our products, regardless of the cause. Essure was approved by the FDA in 2002, and has a well-documented benefit-risk profile, with over 400 peer-reviewed publications and abstracts supporting Essure’s safety, efficacy and cost-effectiveness. Approximately 750,000 women worldwide rely upon the Essure procedure for permanent birth control. 

The US Food & Drug Administration (FDA) reviewed, among other things, the results from a five-year Essure study. The FDA found that “[a]lthough there is evidence of complications, as there are with all medical devices, overall results from this study did not demonstrate any new safety problems or an increased incidence of problems already known.”

The full FDA report can be found here.

In addition, a recent practice bulletin issued by the American College of Obstetricians and Gynecologists (ACOG) has recognized that hysteroscopic tubal occlusion for sterilization has high efficacy and low procedure-related risk, cost, and resource requirements.

No form of birth control is without risk or should be considered appropriate for every woman. It is important that women discuss the risks and benefits of any birth control option with their physicians.

--Bayer HealthCare Pharmaceuticals

Darcy Spears

Darcy Spears

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Darcy Spears is currently the Chief Investigative Reporter for Action News.