Essure Lawsuit Claims Filed Allege The Birth Control Device Can Cause Unintended Pregnancies, Chronic Pain, Abdominal Pain, Organ Perforation And Other Complications And Bayer Failed To Report The Risks Of Its Device.
As Essure lawsuits continue, the U.S Food and Drug Administration (FDA) is recommending restricted use of the Essure birth control system. The recommendation comes after an FDA meeting and the reporting of over 5,000 injury and malfunction reports involving the birth control device. Women also reported headache, fatigue, pregnancy, miscarriage, abdominal pain and a host of other health complications.
The FDA’s Obstetrics and Gynecology Devices Advisory Panel suggested 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. The panel further suggested that a review of ongoing clinical trials and setting up a registry and follow women who had the Essure implant. The panel’s recommendations came after the FDA’s meeting on September 24 where women complained of having chronic pain, unusual bleeding, abdominal and pelvic pain, hallucinations, unintended pregnancy, and muscle weakness due to Essure. Some speakers urged the FDA to recall the Essure birth control system.
[fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/UCM464487.pdf, September 24, 2015]
[nytimes.com/2015/09/25/health/fda-panel-discusses-essure-contraceptive-implant.html?_r=0, September 24, 2015]
“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.
The FDA approved the Essure birth control system in 2002. According to Essure’s manufacturer, Bayer HealthCare Pharmaceuticals, an estimated 750,00 women have chosen Essure as their birth control method. The small device with bendable coils is inserted into the fallopian tubes. The tubes are blocked by scar tissue that forms around the coils over several months which prevents insemination. At last week’s meeting, FDA officials said the agency has received over 5,000 complaints about Essure, including 3,500 complaints of abdominal and pelvic pain, 1,580 reports of unusual bleeding, and 878 reports of allergies.
[fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452250.htm, June 24, 2015]
Southern Med Law notes that independent researchers are calling the clinical trials conducted to put Essure on the market are “flawed.” Diana Zuckerman, president of the National Center for Health Research, told WRIC, the ABC News affiliate in Richmond, Virginia, that she researched some of the clinical trials and found womens’ survey answers changed. For instance, if they marked, “yes” to having pain or health issues, “their answers were sometimes changed to ‘no’ ” Comments about pain were also cross off, she added.
[wric.com/2015/09/28/8news-investigates-advisory-panel-suggests-limited-use-of-essure/, September 28, 2015]
Court documents indicate that five Essure lawsuit claims are pending against Bayer HealthCare Pharmaceuticals accusing the company of concealing Essure’s side-effects of chronic pain, unintended pregnancies and other health complications. The plaintiffs purport the FDA’s premarket approval for Essure is invalid and Bayer should not be shielded from product liability lawsuits over Essure. Bayer denies the allegations and is seeking dismissal of the claims. (Case No. 2:14-07315, 2:14-07316, 2:14-07317, 2:14-07318, 2:15-00384, U.S. District Court, Eastern District of Pennsylvania)
Southern Med Law, is investigating Essure complaints from women, or their loved ones and continues to offer free legal consultations for Essure lawsuits for women across the country. Contact Southern Med Law to learn more about your legal rights by calling (205) 547-5525 or visit www.southernmedlaw.com to fill out a contact for and receive more information.
Southern Med Law is an experienced law firm providing legal representation to the men and women across the country who have been victims of negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. 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 all manner of product liability and personal injury claims. They’re 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
François M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Medical Negligence/MedicalDevice/Pharma/Qui Tam