New documentary called The Bleeding Edge brings attention to controversial medical devices such as Essure
When we think of technology in the medical field, most people would agree that the noninvasive...READ MORE
Essure was hailed in 2002 as the first permanent, non-surgical, birth control implant device to be approved by the U.S. Food and Drug Administration (FDA). Thousands of women rushed to their gynecologists to embrace this new, non-invasive form of pregnancy prevention. Sales racked up quickly along with profitably for the manufacturer of the device, who sold it to Bayer AG for $1.1 billion in 2013. What women didn’t know at the time was that the manufacturer withheld information from the FDA so that its birth control implants could win approval and begin to ring up millions of dollars in sales before being properly and thoroughly vetted.
In reality, the implantation of Essure has resulted in painful and sometimes dangerous complications, including organ damage and unintended pregnancy, for millions of women all over the world. Migration of the device to other parts of the body, perforation of the fallopian tubes, extreme pain during intercourse, and other detrimental health effects have been reported by women who trusted that Bayer would not offer a medical device for sale that was unsafe.
In 2016, researchers at the Northwestern University Feinberg School of Medicine published the results of a study which evaluated the regulation of women’s health devices approved by the FDA over the past 15 years. Compared to more rigorous clinical parameters used by Northwest Medicine on the same devices, researchers determined that 22 percent of the devices approved by the FDA during that timeframe would have failed to meet effectiveness criteria in clinical trials and would have failed to qualify for approval had the researchers’ more stringent requirements been in effect. They also found that 33 percent of the devices were allowed to proceed to market without any follow-up studies to ensure their safety.
In particular, the Northwestern Medicine study pointed out how Essure had been approved based on short-term trials. Researchers highlighted the fact that there was insufficient follow-up to ensure its safety after Essure was approved for sale. Had Essure been a drug instead of a device, the scientists concluded, there would have been far higher standards to meet before approval, and additional follow-up evaluations would have been required afterward.
The bottom line is that injuries suffered by women across the United States and the world from the use of Essure have been and continue to be horrific. In addition to device migration, extreme vaginal pain, and organ perforation, some women have become pregnant despite using Essure and then lost their babies to miscarriage as a result of the device; other babies have been stillborn. Women have been forced to undergo aggressive surgery, including a complete hysterectomy, after suffering widespread organ damage and scar tissue buildup due to movement of the metal Essure coils from where they were originally implanted. Cysts on the ovaries, uterus or fallopian tubes, pelvic inflammatory disease, chronic pain in the arms, legs and lower back, and abdominal spasms have all been attributed to the Essure contraceptive device.
If you have been injured by the implantation, migration, removal, or surgical repair of an Essure birth control implant device, you may be eligible for compensation from Essure manufacturers for your injuries and suffering. The compassionate Essure lawsuit attorneys at Baron & Budd can help you understand your legal options and file a lawsuit on your behalf if you are eligible. Call us at 866-723-1890 or fill out our evaluation form to get started now.