Essure Lawsuits Claim Bayer Failed To Disclose Their Essure Birth Control Poses Potential Risks of Spontaneous Migration, Pelvic and Abdominal Pain and Unintended Pregnancies, Reports Southern Med Law
Essure Lawsuit News: A U.S. Food and Drug Administration (FDA) panel met today to discuss the potential dangers and complications associated with Essure birth control. During the meeting the panel heard testimony from women who had an Essure birth-control device implanted and experienced deteriorating health, chronic pain and other problems allegedly stemming from the device.
FDA representatives said the agency has received 3,500 complaints of abdominal and pelvic pain, 1,580 reports of unusual bleeding and 878 reports of allergies to the device, which is made of nickel titanium alloy. Including one from a 33-year-old woman who said she had Essure implanted and afterward had bouts of muscle weakness, memory loss, hallucinations and kept falling asleep, making it difficult to take care of her three children. The woman said she underwent an hysterectomy to have the contraceptive removed. The panel also heard from an advocacy group that urged the FDA to take Essure off the market.
Essure side-effects lawsuits filed against the contraceptive’s maker, Bayer HealthCare Pharmaceuticals, alleges the permanent birth-control device is prone to dislodge and perforate the uterus and other organs and leads to unintended and ectopic pregnancies. Testimony from Thursday’s meeting shows Essure allegedly brings on other health complications. One woman told the FDA’s Obstetrics and Gynecology Devices Advisory Panel that she participated in the original clinical trial for Essure, and was later diagnosed with celiac disease, a thyroid disorder and myasthenia gravis. The woman said she underwent chemotherapy, transfusions and numerous hospitalizations as a result.
[nytimes.com/2015/09/25/health/fda-panel-discusses-essure-contraceptive-implant.html?_r=0, September 24, 2015]
“The panel will make recommendations to the FDA about Essure, including whether the device should be restricted to use in certain women, but the agency is not obligated to follow those recommendations,” 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.
Court documents indicate that an Essure lawsuit was filed in the U.S. District Court, Northern District of California, against Bayer on behalf of a California woman who alleged that the device’s nickel coil fractured inside of her fallopian tube. The woman maintains she now has heavy bleeding and pelvic pain and has been told by her physician that she needs a hysterectomy. (Case No. 3:15-cv-03995)
Essure was approved as a birth control system in November 2002. The small device with bendable coils is inserted into the fallopian tubes, according to the FDA. To prevent insemination, the tubes are blocked by scar tissue that forms around the coils over several months. In a September 23 article published in the New England Journal of Medicine, Yale University researchers suggested the FDA require more studies that fully show Essure’s safety and effectiveness. The study should focus on such complications as unintended pregnancy, device migration, tubal perforation, bleeding, pain and events such hysterectomy and death, to clearly show how the device performs, the researchers wrote.
[fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452250.htm, June 24, 2015]
[nejm.org/doi/full/10.1056/NEJMp1510514, September 23, 2015]
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
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Birmingham, Alabama 35203
Medical Negligence/MedicalDevice/Pharma/Qui Tam