FDA Essure Monitoring Shows Even Worse Side Effects
On December 31, 2018, the FDA removed Essure from the market. 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. As part of the removal, the agency will also perform Essure monitoring for the next three years.
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 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.
FDA Essure Monitoring Results
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. The FDA compared these results 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.
- Pregnancy − 1 in 10 women using Essure are at risk for pregnancy
- Hysterectomy – Essure removal needs 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.
We Want to Help Essure Victims
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 warn you?
Of course, we want to help send a message that this is not acceptable. We are advocates for those 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. A verdict or settlement may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.