Forty-three-old Cleveland resident Kim Hudak has filed an Essure injury lawsuit seeking $1 million from birth control device manufacturer Bayer. She suffered pain and other injury symptoms and had to undergo multiple surgeries necessitated by injuries associated with the contraceptive. In 2000, at the age of 28, she volunteered to receive the transcervical implant during an early human trial by the manufacturer.
Mrs Hudak’s Essure attorney claims that she had “sharp pain in her right hip” soon after she was implanted with Essure birth control device. While the pain continued despite treatment, she had very painful menstrual periods, migraine, joint pain, flu-like symptoms and incessant fatigue that sapped her ability to work. Her Essure lawsuit has sought $1 million in compensation against Bayer for injuries and lost wages.
FDA Probe Ordered Over Essure
Continuing complaints and initiation of litigations over Essure injury, the FDA has announced to review the risks and safety concerns associated with the birth control device. The Obstetrics and Gynecology Devices Advisory Panel is expected to meet and discuss the need for regulatory action on September 24. Meanwhile, women and consumer groups have begun proceedings in the court and outside to seek the accountability of the manufacturer for Essure injury incidents.
FDA allowed Essure birth control in 2002 after a fast-track approval process. Touted as a long-term birth control, the device is implanted in an outpatient procedure. However, the insertion of the transcervical device itself poses serious risks. The coil-shaped device is inserted into “the fallopian tubes, passing through the vagina, cervix and uterus,” which may result in scar tissue formation and consequent blockage of tubes that obstructs insemination.
Thousands of complaints made in the last four years have already forced the federal drug regulator to issue an alert updating Essure injury risks on the product label. It warned of long-term risks, such as
- Essure migration to lower abdomen and pelvic area
- Essure uterus perforation
- Pelvic pain and inflammation
- Ectopic pregnancy
- Nickel allergy
The FDA has acknowledged of receiving at least 5,093 adverse event reports directly while at least 10 time of that number are expected to have been victims of Essure side effects. Over 18,000 women have joined a social media group on Facebook to share stories on Essure complications. An analysis of MedWatch reports reveals that at least four women died due to Essure injury while 1,408 had menstrual irregularities. Extreme abdominal pain, strap infection, fatigue, headache, bleeding, and internal organ injuries are also frequent.
Essure Injury Leads To More Lawsuits
Consumer groups and citizens demanded revocation of premedical approval and recall of the Essure birth control device in January 2015 citing damaging complications and side effects. Activists, such as Erin Brockovich joined the demand after thousands of women used Facebook to vent their stories related to Essure complications. A summer 2014 Congressional hearing over an Essure injury called for an overhaul of FDA approval process that manufacturer cite to claim immunity from litigations.
The first Essure lawsuit was initiated by a Florida woman. Filed in a Philadelphia court, the lawsuit claims “negligence and breach of express warranties” by manufacturer Bayer citing injuries during the birth control device implant. In April 2015, a woman died, as implant led to uterus puncture and bleeding.
Five more litigations followed the first one highlighting serious injuries, including Essure uterus perforation, and alleging that “Conceptus, the original manufacturer now acquired by Bayer, breached its warranty and committed fraud in the clinical trials to get the device approved by the FDA.” Essure attorneys representing the plaintiffs in an Eastern District Court of Pennsylvania also claim that “FDA premarket approval for Essure is invalid, as the manufacturer failed to report adverse events associated with the birth control devices and this removes protection from product liability.” Hundreds others are expected to join the litigation in the coming months.
Contact our Essure injury attorney or call on 1-800-632-1404 to explore options for filing Essure injury lawsuits and claim compensation and damages for suffering from complications associated with the birth control device.
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