FDA Announces Essure Risks Page As Birth Control Lawsuit Allege Dangerous Side-Effects, Including Ectopic Pregnancy, Pelvic Plan, And Perforation Of Organs Due To Using The Device.
Two months after the U.S. Food and Drug Administration (FDA) announced that it would review complaints of Essure side effects and birth control lawsuits purporting ectopic pregnancies and perforated organs, the federal regulatory agency posted a new page on its website to outline Essure risks and benefits involving the birth control device. The new page, posted on June 24, listed long-term Essure side-effects, which include:
- Unintended pregnancy, including ectopic pregnancy
- Pelvic pain
- Migration of Essure inserts through the fallopian tubes into the lower
- abdomen and pelvis
- Perforation of the uterus or fallopian tubes
- Rash and itching associated with possible nickel allergy
According to the FDA, patients may experience mild to moderate pain during placement of the device and may experience cramping, vaginal bleeding, pelvic or back discomfort immediately following the procedure.
The FDA acknowledged receiving reports of fetal complications associated with Essure that include miscarriages in women who became pregnant following the birth control placement. According to the federal regulator, woman who become pregnant are more than likely to have an ectopic pregnancy, meaning a pregnancy outside of the uterus. The FDA also states on its website that Essure is beneficial to women because it is intended to provide permanent birth control, the inserts do not contain or release hormones, and insertion is typically performed in a doctor’s office in 10 minutes. The federal agency added that it will continue to monitor the safety of Essure to make certain that its benefits of providing women with a non-incisional sterilization choice continue to outweigh its risks.
According to ABC news, the FDA announced that it would look into complaints of the Essure after a citizen’s petition was filed in March with the agency that sought an Essure recall on behalf of thousands of women who were allegedly injured by the permanent birth control device. According to complaints about Essure, the coils in the birth control implant pierce the fallopian tubes and lodge in other organs as well as causing severe back and pelvic pain and prolonged heavy menstrual periods. The law firm notes that the petition claimed the original manufacturer of the device, Conceptus, Inc., perpetrated fraud during the clinical trials, and violated the terms of the FDA’s premarket approval of Essure and violated several federal laws in the manufacturing and marketing of the device.
Essure is marketed by Bayer Healthcare Pharmaceuticals, and because Essure went through the FDA’s premarket approval process, Bayer is shielded from product liability lawsuits. A recently filed Essure lawsuit is asking the court to remove Bayer’s protection. According to the complaint, the FDA approved Essure with a list of conditions, one of which was a requirement for Essure’s manufacturer to report information to the FDA that reasonably suggests that the birth control implant may have caused or contributed to a serious injury. The complaint alleges that Bayer concealed adverse event information associated with the device and thus, invalidated its conditional approval. (Case No. 2:2015cv00384, U.S. District Court, Eastern District of Pennsylvania) Southern Med Law’s Founder, Dr. François Blaudeau, comments that if the lawsuit is successful and the protection is removed from Bayer, then thousands of women who allege that they have been injured by Essure can file their own lawsuit against Bayer.
As both an attorney and gynecologist, Dr. Blaudeau possesses a unique understanding of the medical and legal questions relating to Essure. If you or a woman you love suffered complications allegedly related to Essure, contact Southern Med Law as soon as possible to learn more about your legal rights. You can arrange for a free, no obligation legal consultation by calling Southern Med Law today, at 205-547-5525.
About Southern Med Law
Southern Med Law is a patient and consumer advocacy organization providing legal representation to the 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
Southern Institute for Medical and Legal Affairs
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Phone: (205) 547-5525
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