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Essure Side Effects Lawsuit
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By Jane Mundy
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 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 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 FDA' website, the agency' 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 Essure' 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. "It' 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 panel' 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 Essure' 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 "Essure' 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 weren't 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 citizen' 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 skin—possibly allergic to the metal? "ome of the big things I've 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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