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Essure Side Effects Lawsuit
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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. Consequently, a number of Essure lawsuits have been filed.
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 formedscar tissuearound 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 tube or the uterine wall. It is also suspected of nickel allergy. Some women have reportedly had a hysterectomy or other procedures, such as removal of a fallopian tube, to remove coils.
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."
FDA and Essure
In response to the number of women reporting online and a petition signed by more than 2,100 women urging the federal agency to remove Essure from the U.S. market, the FDA was prompted to review the controversial birth control device in September 2015. At that time, Bayer said Essure has a well-documented benefit-risk profile and has been placed in 750,000 women worldwide. Bayer also stated they are working with the FDA to make new information available to women as it becomes available.
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.
According to the FDAs website, the agencys Obstetrics and Gynecology Devices Panel met on September 24, 2015 to discuss scientific data related to Essure. The FDA said panel members, presenters and the public are invited and can make recommendations during the meeting.
The FDA and Essures Pre-Market Approval
Mark Bell, a metals engineering consultant, was one of the speakers. Reuters said that Bell analyzed a number of Essure devices after they had been removed from patients, and believes there are latent manufacturing processing problems with the devices. Its my expert option that Essure is not a safe product, Bell said. Other speakers urged the FDA to recall the Essure birth control system.
As a result of the panel meeting and the reporting of over 5,000 Essure adverse events, the FDA is recommending restricted use of the Essure birth control system, specifically that women who have a hypersensitivity to metal, autoimmune disease, history of pelvic inflammatory disease, and those with a history of abnormal uterine bleeding should not use the Essure permanent birth control system.
Further, the panel suggested a review of ongoing clinical trials, setting up a registry and follow 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 panels review and suggestions.
Members of Congress in October 2015 pressured the FDA to remove Essure from the market. Representative Mike Fitzpatrick intends to revoke the pre-market approval given by FDA to Essures manufacturer, Conceptus (Essure was purchased by Bayer Healthcare from Conceptus for $1.1 billion) by introducing a bill called the E-Free Act. If the bill is passed, Bayer has 60 days to remove Essure from the market.
Fitzpatrick, a Republican, already has support from a Democrat. According to ABC News, Connecticut Congresswoman Rosa Delauro has written a letter to the acting FDA Commissioner saying she is deeply concerned about the severe adverse health effects of Essure. and Essures benefits do not outweigh the risk and it should be withdrawn from the market.
DeLauro also questioned the FDA regarding the advisory panel hearing. Why werent those women who participated in the 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 citizens 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 womens' 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 Clinical Trials Flawed
Some 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. Also reported by Reuters.
Essure Removal Complications
Dr. Karen Ashby, an OB/GYN at University Hospitals Case Medical Center, told ABC News that Essure is difficult to remove, causes itchy skinpossibly allergic to the metal? Some of the big things Ive seen in my patients is pain, she said.
The 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 precedence 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 alleges 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
Essure: Women Helping Women
Alameda County, CA: The announcement that Fidelma Fitzpatrick is lead counsel for Essure victims should have Bayer even more concerned that litigation may find in favor of plaintiffs. “In a case like [Essure] where we’re talking about birth control devices and women’s health issues it’s particularly important to have women represented,” said Fitpatrick [READ MORE]
Essure Injury Lawsuits Moving Forward
St Louis, MO: A Missouri federal judge at the beginning of December ruled against Bayer’s motion to dismiss its Essure lawsuit and ruled in favor of 32 women who allege serious and permanent injuries from the permanent birth control device [READ MORE]
Essure Contraceptive Gets Black Box Warning
Santa Clara, CA: Bayer’s Essure, a permanent birth control system, now includes a black box warning as mandated by the US Food and Drug Administration (FDA). In a statement released earlier this week, the FDA stated that a Patient Decision Checklist will also be included in the Essure packing, in an effort to support women in making an informed decision about using this controversial and allegedly harmful form of birth control [READ MORE]
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