Essure Side Effects List
The list of Essure side effects is seemingly endless. The website Essure Problems has an exhaustive list of adverse reactions and injuries tied to the Essure birth control device.
Among the more common complaints are:
- Severe, chronic pain (pelvic, abdominal and joint)
- Extreme fatigue
- Migraine headaches
- Abdominal bloating
- Hives and rashes
- Abnormal weight gain
- Cognitive impairment (“brain fog”)
- Nausea and vomiting
Many of these and other Essure problems are common symptoms of autoimmune disorders.
In addition to these side effects, there are numerous cases of serious physical injuries:
- Perforation of the Fallopian tubes
- Perforation of the uterus
- Bowel perforation
- Migration of the device into the peritoneal cavity
Perhaps the most striking adverse effect of Essure implantation was revealed in the November 2015 issue of the medical journal BMJ (originally the British Medical Journal). The journal published a study by four doctors at Cornell University’s Weill Medical College that compared the Essure sterilization procedure with the other most common surgery for sterilization: tubal ligation. In tubal ligation, the Fallopian tubes are surgically cut and tied off with the patient under general anesthesia. The doctors gathered data on thousands of patients who underwent the Essure procedure or tubal ligation in New York State between 2005 and 2013. They compared outcomes between 8,048 women who were implanted with the Essure device and 44,278 patients who received tubal ligation.
Since implantation of the Essure permanent birth control device does not require either the general anesthesia or abdominal incision used in tubal ligation, it is considered to be the less invasive procedure. The Cornell researchers, however, found that one year after surgery, women implanted with the Essure were 10 times more likely to need additional surgery (“reoperation”). After two years, they were eight times more likely to undergo a reoperation and even at three years they were still six times more likely to need reoperation. The doctors noted that “most of the adverse events reported by patients for the Essure based procedure were injuries that would require a reoperation.” Surprisingly, general anesthesia was still used in half of the Essure implantations.
One reoperation that is shockingly common following Essure implantation is the hysterectomy. Earlier this year, Madris Tomes, a data analyst and founder of the health research group Device Events, presented statistics on Essure-associated hysterectomies to the FDA, data taken from the FDA’s own records. According to Tomes, who formerly worked for the FDA, more than 18,000 women have reported having hysterectomies due to Essure complications.
Women Speak Out Against Essure Birth Control
The only way to truly reveal the horrendous suffering of the women who have been injured by Essure birth control side effects is to listen to their own stories. One instantly understands why so many have filed an Essure lawsuit.
Many of the stories are found in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, where over 29,000 adverse reaction reports tied to Essure have been filed—nearly 12,000 in 2017. In all likelihood, the situation is worse than these figures indicate. Many consumers are unaware of the FDA reporting system and manufacturers often do not report or misreport adverse reactions. An FDA inspector who reviewed Conceptus documents between December 2010 and January 2011, found reports sent by health professionals of perforation of the bowels and movement of the Essure device into patients’ abdominal cavities. The reports were never sent to the FDA.
Reports in the MAUDE database are not minor. Manufacturers are only required to submit them if one of their devices “may have caused or contributed to a death or serious injury or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.”
The following MAUDE report was submitted by one woman who had the Essure insertion procedure:
Within months of my Essure implant I began constant vomiting to the point of removing my gallbladder, which did not help, constant hot flashed, constant cramping and sharp pains, diagnosed with fibromyalgia, anxiety, and PTSD to the point of being admitted to a neurological center. I wake every morning with “morning sickness” and constant pains throughout my entire body, my joints and muscles …. Within a week after my implants I got my very first ever migraine; the migraines have gotten so frequent I find myself battling them weekly sometimes lasting two or three days. -FDA report filed by Essure victim.
Essure Recall Timeline
|November 4, 2002||FDA approves Essure.|
Warning that women hypersensitive or allergic to nickel should not undergo
Essure implantation removed from information provided to patients and physicians.
|2013||Essure label updated to warn patients of chronic pain and device migration.|
|September 24, 2015||
Obstetrics and Gynecology Devices Panel of the FDA’s Medical Devices
Advisory Committee meets to discuss Essure problems, hear testimony from victims.
|February 29, 2016||
FDA orders black box warning placed on Essure label, orders
Bayer to conduct post-marketing study.
|February 20, 2017||Brazil halts sales of Essure.|
|August 3, 2017||European Union (EU) suspends license to sell Essure in the EU for 3 months.|
|August 30, 2017||Australia recalls Essure device.|
|September 18, 2017||Bayer announces end of non-U.S. sales of Essure.|
|April 9, 2018||FDA restricts sales of Essure to women who have read and signed brochure on device risks.|
|July 20, 2018||Bayer announces it will discontinue Essure sales.|
Filing an Essure Birth Control Lawsuit
A principal of federal law presents a legal roadblock to filing an Essure lawsuit, but recent court decisions have removed that barrier for many. The Essure device is classified by the FDA as a Class III device. Class III devices are devices that potentially pose a high risk of illness or injury and for this reason they are required by the FDA to undergo a more demanding approval process referred to as a PMA (premarket approval) process.
But a legal concept known as federal preemption protects medical devices approved under the PMA process. Federal preemption essentially means that where federal and state laws are in conflict, federal law prevails. Since the FDA is a federal agency, medical devices that have undergone the FDA’s most rigorous PMA approval process are considered protected from medical device lawsuits brought at the state level and based upon state laws, unless those laws match the FDA’s federal restrictions.
Recently however, a judge in the Superior Court of California, Alameda County, rejected arguments by Bayer that 11 Essure lawsuits in that state should be dismissed under federal preemption. A judge in Pennsylvania is also permitting Essure lawsuits in that state to go forward on a more limited basis.
The grave injuries suffered by women who received the Essure implant demand that their lawsuits be heard. That may not happen in all states, but in at least some it will.
The Essure story is one of flawed testing, deceptive marketing and thousands of women who have suffered horrific pain and injury. If you are one of those women, the attorneys at Baum Hedlund Aristei & Goldman would like to hear from you. Please contact us by means of our form or by phone at (855) 948-5098 for a free, no obligation consultation.