Essure Lawsuits Contend Bayer’s Birth Control Deviced Caused Organ Perforation, Spontaneous Migration, Ectopic Pregnancies And Chronic Pain Reports Southern Med Law
Essure side-effects lawsuits filed against Bayer HealthCare Pharmaceuticals have come into the focus of Good Morning America as the FDA gets ready to meet this week to examine complaints that the Essure birth control device causes complications such as perforation of the uterus or fallopian tubes, and chronic pain. In preparation of Thursday’s meeting, Southern Med Law has learned that the FDA posted 90-pages of information containing questions for its Advisory Panel and has set aside time to receive comments from the public to express Essure problems. There are currently 5 Essure side effects lawsuits filed in the U.S. District Court, Eastern District of Pennsylvania and it is believed that more Essure complaints will be filed due to the large number of complaints the FDA has received.
FDA Advisory Panel looking into Essure Side Effects
The FDA Obstetrics and Gynecology Devices advisory panel is also expected to make recommendations about the effectiveness, safety and risks of the birth control system. According to reports the FDA has received 5,093 adverse events reports regarding Essure since the time the birth control system was first approved. Of the reports received, 4,608 were coded as patient injury reports, 474 as device malfunctions and 11 as deaths, including 5 fetal deaths. Women also reported headache, fatigue, pregnancy, miscarriage, abdominal pain and a host of other health complications.
“These are serious complaints against Essure and due to the numerous amounts of reports received from women who have been harmed by the Essure birth control system there have been requests made to the FDA to take the birth control device off of the market,” 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 who have been seriously injured allegedly by defective medical devices. www.southernmedlaw.com
Essure is a permanent birth-control system developed by Bayer HealthCare Pharmaceuticals and received clearance from the FDA in November 2002. The small device with bendable coils is inserted through the vagina, cervix and uterus and into the fallopian tubes. The tubes are blocked by scar tissue that forms around the coils over several months, and this process prevents insemination, according to the complaints. Conceptus, Essure’s original manufacturer, said in early 2013 that about 730,000 women worldwide have undergone the birth control implant procedure since the device was first approved by the FDA in 2002. [globenewswire.com/news-release/2013/02/05/521086/10020626/en/Conceptus-R-Announces-Enrollment-of-First-Patient-in-European-Clinical-Trial-for-Next-Generation-Essure-R.html, February 5, 2013]
Court documents indicate that five Essure lawsuits are pending against Bayer HealthCare Pharmaceuticals accusing the company of concealing adverse events involving Essure that include chronic pain, pelvic pain, organ perforation and ectopic pregnancy (which occurs outside of the uterus). The Essure complaints, filed in the U.S. District Court, Eastern District of Pennsylvania, contend that the company’s actions invalidates Essure’s conditional approval by the FDA. In its response, Bayer, which acquired Conceptus in 2013, is asking for dismissal of the claims because the company is shielded from Essure product liability lawsuits. (Case No. 2:14-07315, 2:14-07316, 2:14-07317, 2:14-07318, 2:15-00384)
Southern Med Law is investigating potential Essure side-effects lawsuits from women, or their loved ones, who believe they have suffered complications from the Essure birth control device, contact Southern Med Law to learn more about your legal rights. You can arrange for a free, no obligation legal consultation to learn more about your legal rights. Call Southern Med Law today, at (205) 547-5525 or you can visit www.southernmedlaw.com to fill out a contact for and receive more information.
About Southern Med Law
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