Essure Lawsuit - Permanent Birth Control DeviceClick here for a free case evaluation
What you need to know NOW!
Have you suffered serious complications after receiving the non-surgical permanent birth control device known as Essure? Our attorneys are reviewing cases of women who have been seriously injured. Please contact our Essure lawyers at 1-844-THELAW4 to have a free case evaluation.
Essure Permanent Birth Control Device
Essure is a non-surgical birth control device inserted by a doctor into a woman’s fallopian tubes. The nickel-based metal coil’s purpose is to cause blockage of the fallopian tubes preventing pregnancy. The sterilization procedure is done in a doctor’s office without any incisions. Manufactured by Bayer HealthCare Pharmaceuticals, the FDA approved Essure in 2002 through a fast-track approval process because Essure was the first permanently sterile birth control that didn’t require surgery.
Complications with Essure
From November 2002 to May 2015, the FDA received more than 5,000 medical device reports on Essure. Patients experienced problems including the device movement including coils breaking and causing perforations of the fallopian tubes. They stated Essure caused pain and bleeding, heavier menstrual cycles, headaches and nickel allergies. Some patients reported needing hysterectomies because of Essure. Some women also reported unintended pregnancies resulting in birth defects, miscarriages and stillbirths. According to the FDA, some of these problems were not documented in the initial clinical trials used for approval.
“Other reports describe symptoms that are not included in the labeling, and were not observed in post-approval studies, or described in the clinical literature such as extreme fatigue, depression and weight gain.” – FDA.gov On September 24, 2015, the FDA held an all-day hearing on Essure asking questions to a panel of experts and to patients. Some experts questioned Bayer’s clinical studies.
“How can Bayer and the FDA have no knowledge of nickel allergies?” asked Dr. Peter Schalock, a dermatologist at Massachusetts General Hospital, his voice incredulous. “Where did you test these people? How did you test the people? What did you test them with? Are we just making this up for fun or is there data?” - The New York Times, September 24, 2015
According to the National Center for Health Research, clinical trial participants said their complaints were ignored by researchers. Questions were raised on whether the studies were truly non-biased citing the studies were funded by the device manufacturer.
On March 1, 2016 the U.S. Food and Drug Administration said it will require a new "black box warning" label for Essure. A black box warning in the labeling of products is "designed to call attention to serious or life-threatening risks," according to the FDA website.
In March 2016, a U.S. District Judge John Padova allowed women suing Bayer to proceed with their negligent misrepresentation and negligent failure-to-warn claims. Five plaintiffs claimed the Essure device moved from their fallopian tubes into the uterus, rectum and colon, causing internal injuries. Four of the women had to have hysterectomies. The fifth women had to have her fallopian tubes removed and delivered a baby with birth defects.
"Here, the complaint alleges the substance of the alleged misrepresentations, which primarily appeared on Bayer's ¬website and in Essure brochures that Bayer 'intentionally made the statements so that plaintiff[s] would be induced to have Essure implanted' and that plaintiffs 'justifiably relied' on those misrepresentations prior to implantation, and never would have had Essure implanted had they been aware that the representations were false. We conclude that these allegations are sufficient to state a plausible negligent misrepresentation claim under the circumstances of this case," Padova said.
Essure Serious Health Problems
Women have reported the following problems with Essure:
• Hysterectomy after the ESSURE was installed
• Device breakage or fracture into pieces
• Surgery to repair fallopian tubes
• Device migration
• Bowel or other Organ perforation
• Device breakage or fracture into pieces
• Adverse reactions due to nickel allergy
• Coils breaking off the device
• Coils moving from the fallopian tube
• Coils puncturing the fallopian tube
• Ectopic pregnancy
• Miscarriage, stillbirth or unintended pregnancies with birth defects
If you have had permanent birth control by Essure and have experienced any of these problems, please contact our Essure attorneys to discuss your case. Give us a call at 1 (800) 515-1496.