Interim Essure Study Shows More Than 1-in-5 Women Suffer Allergic or Hypersensitivity Reactions: FDA
An ongoing study involving problems with Essure birth control suggests that more than 20% of women implanted with the device may be suffering allergic or hypersensitivity reactions, facing an increased risk of chronic abdominal pain and abnormal bleeding and higher rates of gynecological surgical procedures, according to federal regulators.
On July 8, the FDA issued a press release about the interim results of a mandated Essure postmarket surveillance study.
While the data is still evolving, the preliminary results seem to confirm a number of serious problems with the Bayer birth control device, which is no longer available on the market.
Essure was previously sold by Bayer as a permanent form of birth control, involving flexible coils inserted into the Fallopian tubes. It was used during a procedure designed to cause scar tissue to develop, which blocks the tubes and prevents insemination. However, the device was removed from the market amid thousands of Essure lawsuits filed by women who experieced painful and debilitating complications, including migration injuries, perforations, severe reactions and other problems.
Although Essure was recalled from the market in most countries in 2017, Bayer continued to sell the device in the United States until the end of 2018. In the face of mounting pressure and publicity about the injuries women were experiencing from Essure, the company announced in July 2018 that it was removing Essure from the US. market on December 31, 2018.
Following the decision, the FDA confirmed Bayer would be required to extend a post-market surveillance study and take other measures to ensure long-term Essure oversight well after production and sales have ceased.
Essure Study Results
The open-label, non-randomized observational cohort study compares the use of the Essure implant with laparoscopic tubal sterilization (LTS). It involved women who were at least 21 years old and who had not been pregnant within the previous six weeks before participation in the study. Followup of the 1,128 subjects will be conducted over 60 months. Enrollment in the study ended December 31, 2019.
The interim results indicate that 22.3% of women who received the Essure reported suffering allergic or hypersensitivity reactions, compared to only 12.5% in the LTS group. The results also revealed that 9.1% of the Essure subjects suffered chronic lower abdominal pain or pelvic pain, compared to 4.5% in the LTS group, and found that 16.3% of the Essure patients reported abnormal uterine bleeding, compared to 10.2% in the LTS group.
“Early results show that Essure patients tend to have higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding compared to women who had laparoscopic tubal ligation as their permanent birth control,” Dr. Terri L. Cornelison, director of the FDA’s health of Women Program, said in the press release. “Also, patients with Essure had higher rates of gynecologic surgical procedures—including surgery to remove Essure—than patients who had tubal ligation.”
The interim findings indicate about 14.3% of Essure recipients had the device removed within the first 21 months. However, only 1.9% suffered unintentional organ perforation, though that was nearly double the 1.1% rate in the LTS group. Both procedures appeared to be highly and virtually equally effective at preventing pregnancies.
The subjects of the study will continue to follow up with researchers every year for the next five years.
Bayer currently faces more than 18,000 product liability lawsuits filed by women nationwide, each involving similar allegations that the Essure birth control coils were unreasonably dangerous and defectively designed. With approximately 750,000 women worldwide implanted with the device, and about 70% of those procedures in the United States, the size and scope of the litigation may continue to increase as Essure causes problems for women with the device in their body.