Thousands of women implanted with Essure are experiencing painful and sometimes deadly side effects.
Essure is a soft, flexible metal spring made from a nickel-titanium alloy. Doctors offer it to women as an alternative to the invasiveness of tubal ligation. Essure typically involves general anesthesia and a laparoscopy in the doctor’s office unlike a tubal ligation, which occurs in a hospital and requires surgery. A doctor inserts one Essure coil into each fallopian tube. Scar tissue will form around the coil to obstruct sperm from fertilizing an egg in the fallopian tubes. Three months after the procedure, women must have a follow-up procedure involving an X-ray and dye to confirm that the tubes are fully blocked.
Bayer, the manufacturer of Essure, claims it is nearly 100 percent effective at preventing pregnancy and is perfecting safe; however, thousands of women disagree.
Essure is Fast-Tracked & Dangerous
The FDA fast-tracked approval of Essure in 2002 with the requirement that researchers will monitor patients in the initial study for an additional 5 years. Regrettably, researchers followed only 366 of the original 618 patients. Out of those 366, 15 had hysterectomies, 38% had usually heavy periods, 5% suffered from recurrent pelvic pain and 4% painful intercourse.
Now, the FDA is requiring Bayer to complete a new study to assess the risks of Essure with over 2,000 women for at least 3 years. This study will concentrate on those who experienced unplanned pregnancies, pelvic pain and needed surgery to replace or remove Essure. Then, researchers will compare women who use Essure to others who chose other methods of sterilization.
Study Links Essure to Higher Surgery Risk
Moreover, the British Medical Journal published a study in 2015 linking Essure with a 10-fold risk of needing follow-up surgery compared to tubal ligation. Researchers based their conclusions on an analysis of over 50,000 women in New York. Doctors sterilized these women between 2005 and 2013. During this time, 2.4% of Essure users needed additional surgery versus 0.2% of those who had laparoscopic sterilization. Additionally, this equated to about 10,000 women needing additional surgery after having Essure.
Essure Black-Box Warning
The FDA reserves black-box warnings for the most serious products carrying life-threatening risks. Essure has one due to concerns over its serious complications. The FDA mandated the change in February 2016 following a new post-market clinical study that determined heightened risks for particular women. Still, the FDA has not recalled the device.
In November 2016, the FDA announced an update to Essure’s labeling. The new labeling will include warnings for the risk of implant perforation, device migration, allergic reaction, pain and other possible adverse events. Included in the box will be a patient checklist. It reviews possible risks such as the metal coil perforating the uterus or fallopian tubes.
When manufacturers produce unsafe products that create pain and suffering, you deserve compensation. Although no amount of money will change the fact that you have suffered a serious injury as a result of manufacturer irresponsibility, compensation will help offset your current and future medical costs, as well as provide for the pain and suffering you have experienced. By filing, you may also help protect other women and their families from needless distress.
- Pregnancy − 1 in 10 women using Essure are at risk for pregnancy
- Hysterectomy – The removal of Essure can only be performed by undergoing a complete hysterectomy.
- Allergic Reaction− The device will be incompatible because of a nickel allergy.
- Abdomen and Pelvis Perforation − When Essure coils migrate out of the fallopian tubes, they can tear the uterus or pelvic wall.
- Death − The FDA has linked four deaths associated with Essure usage.
Essure Removed from Market
The FDA released an announcement that after December 31, 2018, the manufacturer can no longer sell or distribute Essure. This decision follows the agency’s April safety action of restricting sales and distribution. Previously, the United States was the only country that still allowed women to get the device. Every other country recalled Essure.
Also in the announcement, the FDA wanted to ensure women already with the device that the agency will continue to monitor safety regulations. In fact, Bayer must continue to enroll new participants in their post-market study. Researchers will follow new participants for no less than three years, and Bayer will continue to submit reports to the FDA on the study’s progress and results.
Essure Monitoring Update
On July 8, 2020, the FDA posted interim results for the postmarket surveillance (“522”) study on Essure. The early results show that women with Essure have higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding. This is compared to women who had a laparoscopic tubal ligation. Also, patients with Essure had higher rates of gynecologic surgical procedures. This includes surgery to remove the device. Also, pregnancy rates were similar for patients with Essure and tubal ligation.
The FDA was supposed to make an announcement after three years, however, the patient outcomes were so bad that they wanted to notify the public after one year.
We Want to Help Essure Victims
Furthermore, it is your right for manufacturers to inform you about the long-term risks associated with the medical devices, and it is the responsibility of manufacturers to provide this information. If you or a loved one has suffered any side effects from Essure, you should demand accountability from Bayer. Why did no one tell you?
Of course, we want to help send a message that this is not acceptable. We are advocates for consumers who have been harmed by dangerous products, and likewise, we have the experience necessary to successfully litigate these cases.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.
Essure Lawsuit Litigation
There has been positive momentum in current litigations. Recently, judges have upheld multiple claims in Californa, St. Louis, Missouri and Pennslyvania. In fact, Bayer has set aside millions of dollars to deal with the legal ramifications their medical device has caused.
Discovery will be completed by October and currently are finalizing bellwethers to be heard on March 1, 2021.
There is also JCCP4887 in California. Judge Winifred Smith postponed the trial slated for March 2020 until Fall 2020. Most of the discovery and interviewing of experts have been completed.
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. A verdict or settlement could also provide compensation for your injuries and damages. The types of recoverable losses are:
If a person dies from complications from a drug, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
If the conduct of a company is found to be highly reckless, punitive damages may be awarded to punish the company and deter similar conduct in the future. If you suffered after a doctor implanted Essure, please speak to us to learn more about your rights.
The Michael Brady Lynch Firm is currently accepting cases in all 50 states. Please use the form on this page or call toll-free 24 hours a day at 877-513-9517.