The FDA Says It Has Received Thousands Of Adverse Event Reports Of Essure Birth Control Side-Effects Including Pelvic Pain, Ectopic Pregnancy, Organ Perforation, And Fetal and Adult Deaths.
The U.S. Food and Drug Administration (FDA) added a new page on its website detailing the Essure birth control side effects, and has also announced that is has scheduled a meeting of the FDA’s Obstetrics and Gynecology Devices Panel to discuss data regarding Essure’s safety and effectiveness. The federal regulatory agency noted that the risks of the Essure birth-control device included unintended pregnancies, pelvic pain and perforation of the uterus or fallopian tubes, among other complications. The FDA stated on its website that it is seeking feedback from presenters, panel members and the public at its September 24 meeting to help the agency form “recommendations and next steps about Essure.”
“Earlier this year, the FDA received a petition to review the birth control device after thousands of women were purportedly injured by the Essure implant. Convening a public meeting will allow the FDA and its panel to hear first-hand accounts from women who have been seriously injured by this birth control device,” said Dr. François Blaudeau, founder of Southern Med Law.
Southern Med Law is currently representing women from around the country in product liability lawsuits. Their Founding, attorney, Dr. Francois Blaudeau, possesses a unique understanding of the medical and legal fields as he is also practicing obstetrician/ gynecologist and can answer questions relating to Essure. If you or a woman you love are believed to 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 by calling 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.
As stated by the FDA, Essure is a birth control implant offered as an outpatient procedure by many medical facilities to provide long-term birth control. During the surgery, a doctor inserts bendable coils into the fallopian tubes, passing through the vagina, cervix and uterus. This process causes scar tissue to form around the coils over several months, which blocks the tubes and prevents insemination, according to the FDA.
[fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452254.htm, June 24, 2015]
The FDA stated on its website that it has received 5,093 adverse event reports regarding Essure from November 2002, when the device was first approved, to May 31, 2015. Most of the reports were voluntary from women who received the implants, the FDA noted. During this period, the FDA received:
• 3,353 reports of pain and abdominal pain
• 1,408 reports of menstrual irregularities
• 1,383 reports of headache
• 966 reports of fatigue
• 936 reports of weight fluctuations
Most of the reports listed multiple patient problems, with the most frequent problems being:
• Patient device incompatibility (for example, possible nickel allergy)
• Migration of the device or device component
• Device operating differently than expected
• Device breakage
• Malposition of the device.
The FDA also received five reports involving fetal deaths that occurred in women who became pregnant following placement of Essure. There were also four adult deaths reported, one reportedly due to uterine perforation during device placement and one death related to an air embolism during device removal surgery, according to the FDA. The other deaths were due to a suicide and a post-operative Group A Strep infection, according to the FDA report.
The law firm notes that earlier this year, the FDA received a petition submitted on behalf of thousands of women who said that they were injured after having the Essure birth control implant, and experienced such complications as the coils piercing the fallopian tubes and lodging in other organs which caused severe back and pelvic pain.
Court documents show that Bayer Healthcare Pharmaceuticals, which markets Essure, is protected from product liability lawsuits regarding the device but according to a recently filed Essure lawsuit, Bayer purchased Conceptus, the company that originally developed Essure. The birth control lawsuit claims that Essure went through the FDA’s premarket approval process and was granted approval by the FDA with a list of conditions, which included the manufacturer informing the FDA of Essure causing or contributing to any serious injury. The Essure lawsuit contends that Bayer concealed adverse event information associated with the device which invalidates its conditional approval. (Case No. 2:2015cv00384, U.S. District Court, Eastern District of Pennsylvania)
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
2224 1st Ave., North
Birmingham, AL 35203
Phone: (205) 547-5525
Fax: (205) 547-5526