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Essure Side Effects Lawsuit
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By Anne Wallace
Essure is a birth control device intended to cause permanent sterility without surgery, marketed and distributed by Bayer Healthcare. Since its approval in 2002, the FDA has received thousands of complaints about Essure side effects. Essure lawsuits have multiplied, and the FDA has required a ”black box” warning since 2016. Bayer has now taken the device off the market except in the US, reportedly for commercial reasons.
En Español [ANTICONCEPTIVO ESSURE]
Essure contains two nickel-titanium coils that are inserted through the vagina into the fallopian tubes. After Essure is implanted, a barrier of tissue is formed—scar tissue—around the implant which prevents sperm from reaching eggs.
Essure Side Effects
Essure side effects include chronic pain, heavy bleeding, fatigue, and skin allergies. The device has also been known to migrate, which can lead to perforation of the fallopian tubes or the uterine wall. It is also suspected of causing nickel allergy. Some women have reportedly had a hysterectomy or other procedures, such as removal of a fallopian tube, to remove coils.
In May 2017, the FDA ordered Bayer to conduct a postmarket surveillance study to gather more data about the device’s benefits and risks. According to the FDA website, the agency will make interim study results and updates available on the Essure Postmarket Surveillance Study page. In 2016 the device cost the company $413 million, according to its annual report. At least 3,700 lawsuits sought class action certification as of the end of January 2017. More lawsuits are anticipated.
FDA and Essure
From 2002 through 2015, the FDA received 5093 medical device reports related to Essure. In that report, the agency said,"The majority of reports received since 2013 have been voluntary reports, mostly from women who received Essure implants." In 2015, Bayer still maintained that Essure had a “well-documented benefit risk profile.”
Even at the time, some doctors disagree with Bayer's "well-documented" statement. Reuters reported that Dr. Sebastiaan Veersema, a gynecologist in the Netherlands, has implanted the device in nearly 1,400 people and trained dozens of practitioners in its use. He now believes more research needs to be done to establish what, if any, relationship exists between the device and the problems relayed by some patients.
Dr. Cindy Basinski consults for Bayer. She testified on the company's behalf at the FDA meeting and has implanted about 1,100 devices since with minimal complications. According to Reuters, Basinski has had "a couple" of patients come to her with complaints, and one asked for the device to be removed.
On September 24, 2015, the FDA’s Obstetrics and Gynecology Devices Panel met to discuss scientific data related to Essure..
The FDA and Essure Pre-Market Approval
At that meeting, Mark Bell, a metals engineering consultant, testified that he believed that there were latent manufacturing processing problems with the devices. "It’s my expert option that Essure is not a safe product," Bell said at the time. Even then, other speakers urged the FDA to recall the Essure birth control system,
As a result of the 2015 panel meeting and the reporting of a growing number of Essure adverse events, the FDAihasrecommendde restricted use of the Essure birth control system, More specifically, women who have a hypersensitivity to metal, autoimmune disease, history of pelvic inflammatory disease or abnormal uterine bleeding should not use the Essure permanent birth control system. Further, the panel suggested reviewing ongoing clinical trials, setting up a registry and following women who had the Essure implant.
"Now that the panel has submitted its recommendations, the FDA will weigh those recommendations and determine the next step for the Essure birth control system," says Dr. François Blaudeau, a founding partner of Southern Med Law, who is also a practicing attorney and obstetrician/gynecologist, who strongly advocates for and represents women in Essure lawsuits.
Here is a summary of the 2015 panel's review and suggestions.
Members of Congress in October 2015 pressured the FDA to remove Essure from the market. Representative Mike Fitzpatrick intended to revoke the pre-market approval given by FDA to Essure's manufacturer, Conceptus (Essure was purchased by Bayer Healthcare from Conceptus for $1.1 billion) by introducing a bill called the E-Free Act. Had the bill been passed, Bayer would have had 60 days to remove Essure from the market.
Fitzpatrick, a Republican, had support from Democratic Congresswoman Rosa DeLauro. Representative DeLauro wrote to the acting FDA Commissioner to say that she was "deeply concerned about the severe adverse health effects of Essure,"and "Essure' s benefits do not outweigh the risk and it should be withdrawn from the market."
Essure Clinical Trials "Flawed"In 2015, DeLauro also questioned the FDA regarding the advisory panel hearing. Why weren't those women who participated in the early Essure clinical trials allowed to report to the panel? According to DeLauro, their public testimony would show that patient ages and information on their Essure complications were changed by the Essure sponsors before data was submitted to the FDA for approval. Further, DeLauro said that independent experts were not given sufficient time, and that the FDA has only posted 11 out of more than 3,000 comments submitted to the docket of the citizen's petition calling for an Essure recall. Diana Zuckerman, president of the National Center for Health Research, told WRIC, the ABC News affiliate, that after researching some of the clinical trials she found women’s survey answers changed. If pain or health issues were marked "yes," their answers had sometimes been changed to "no." Zuckerman also said comments about pain were sometimes crossed off.
Essure Removal ComplicationsSome doctors are concerned not only with implantation of Essure, but how the device is removed, as there is no standardized method for removal. Dr. Shawn Tassone, who practices at a clinic in Austin, Texas, told Reuters (Sept 22, 2105) that, "Instead of saying Essure is an easy procedure with no side effects, (they should) say this is a surgery and there are people reporting complications."
Dr. Karen Ashby, an OB/GYN at University Hospitals Case Medical Center, told ABC News that Essure is difficult to remove, causes itchy skin—possibly allergic to the metal? "One of the big things I've seen in my patients is pain," she said.
Essure LawsuitsThe first Essure lawsuit was filed in 2014 in Philadelphia challenging the application of federal preemption to Essure lawsuits. It alleges that the doctrine should no longer apply to Essure. If the case is successful, it could set a precedent for other Essure victims to file lawsuits seeking compensation for their injuries.
A federal lawsuit was filed in September 2015 by a South Carolina woman, just a few days before the FDA advisory panel convened to review Essure complaints. In her lawsuit, Tanya De La Paz alleged the nickle coil fractured inside of her fallopian tube causing has heavy bleeding, intense pelvic pain and she has been told by doctors she needs a total hysterectomy. In 2013, she had the device removed along with her right fallopian tube, on advice from Bayer. The lawsuit further claims that Bayer has been concealing evidence of adverse reactions to the birth control device.
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ESSURE SIDE EFFECTS LEGAL ARTICLES AND INTERVIEWS
Bayer Reports Spike in Essure Lawsuits and Congress Questions FDA
November 8, 2017Decatur, IL: Litigation involving Essure is taking its toll on Bayer. In less than a year, the permanent birth control device manufacturer has seen lawsuits more than double, and it has been removed from every global market, except in the U.S [READ MORE]
Bayer Bans Essure Outside US, Is FDA Lagging?
October 10, 2017Richmond, VA: Bayer has stopped selling its Essure outside of the U.S. citing “lack of interest” and “commercial reasons”. But those reasons may not be quite accurate. Many countries have banned the permanent sterilization device due to product and safety concerns. So, why is it safe for women in America [READ MORE]
Bayer Pulls Essure Birth Control Device From All Countries Except US
September 26, 2017Washington, DC: Bayer has announced that it is taking its female sterilization device, Essure, off the market in all countries where it is currently marketed and sold, except the US. The company said it was taking this action due to commercial reasons, and not because of allegations of side effects associated with the device [READ MORE]
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