Over 5,000 Complaints of Serious Essure Side-Effects Filed With The FDA In 2016


Essure Side-Effects Lawsuits Claim Women Suffer Miscarriages, Heavy Bleeding, Hysterectomies, And Other Complications From The Birth Control Device.

Essure side-effects Essure-Birth-Control-Lawsuits-Southern-Med-LawAs Essure side-effects lawsuits continue to be filed in courts nationwide, more than 5,000 complaints regarding the birth control were filed with the U.S. Food and Drug Administration (FDA)in 2016. Complaints filed with the FDA mirror those found in Essure side-effects lawsuits that claim Essure causes women to suffer chronic pelvic pain, heavy bleeding, miscarriages, hysterectomies, punctured organs, and other injuries including adult and fetal death. In its 2016 annual report, Bayer, Essure’s manufacturer, said it is facing 3,700 Essure lawsuits in the United States. [annualreport2016.bayer.com/servicepages/search.php?q=essure&pageID=29873]

On April 18, the FDA reported an updated of its activities involving Essure. The FDA received 5,019 complaints about the birth control device last year and 57 percent were reported by Bayer. The most frequently reported patient problems were:

• Pain/abdominal pain (10,746)
• Heavier menses/menstrual irregularities (5,377)
• Headache (4,396)
• Fatigue (3,560)
• Weight fluctuations (3,270)

Additionally, 14,919 medical device reports related to Essure have been filed from November 4, 2002, through December 31, 2016. Included were 38 death reports, but eight reports were coded incorrectly and no deaths were indicated, according to the FDA. Of the remaining 30 reports, six relate to four adult deaths; 21 reports relate to 18 incidents of pregnancy loss; two reports relate to two incidents of a death of an infant after live birth; and one report specifies a death but does not indicate whether the death was before or after birth.

“The reports filed with the FDA over Essure appear to support the Essure lawsuits that allege women suffer serious injuries and death because of the birth control device,” says Dr. François Blaudeau, co-founder of Southern Med Law, who is also a practicing obstetrician/ gynecologist and a strong advocate for woman’s medical issues.

Southern Med Law’s attorneys are currently representing numerous women in Essure side-effects lawsuits who have suffered complications from the Essure birth control device. You can arrange for a free, no obligation Essure lawsuit consultation to learn more about your legal rights. Call Southern Med Law at (205) 547-5525 or you can visit www.southernmedlaw.com to fill out a contact for and receive more information.

Essure is a permanent birth control system with two metal coils that are inserted into the fallopian tubes. Scar tissue, which forms around the coils over three months, blocks the tubes and prevents conception. The FDA began investigating Essure after a Citizen’s Petition called for the agency to ban Essure because of the numerous problems associated with the birth control device. The FDA closed its investigation of the petition last year without removing the birth control device from the market. In February, however, the FDA ordered Bayer to conduct a new clinical study on Essure and put a black box warning on the label about the risks of using Essure.

Bayer has asked state and federal judges to dismiss Essure lawsuits that allege women develop auto-immune disorders, weight problems, organ perforation, nickel allergies, and other complications from the device. Bayer asserts that it is protected against product liability lawsuits because Essure went through the FDA’s rigorous premarket approval process for medical devices. So far, Bayer’s requests have been rejected. In September, an Alameda County Superior Court judge in California approved a consolidation of Essure complaints filed on behalf of 900 women. In February, a federal judge in Pennsylvania allowed certain claims to move forward in five complaints that were among the first Essure side-effects lawsuits filed against Bayer.

About Southern Med Law And Filing An Essure Side Effects Lawsuit

Led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in the Essure product liability and personal injury claims. Southern Med Law is a patient and consumer advocacy organization that is not afraid to take on the nation’s largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.

Southern Med Law
Southern Institute for Medical and Legal Affairs
2224 1st Ave., North
Birmingham, AL 35203
Phone: (205) 547-5525
Fax: (205) 547-5526

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