The interim results of a postmarket study of Essure shows that more than 20% of women implanted with the birth control device suffer allergic or hypersensitivity reactions and may also be at risk for abnormal bleeding, chronic abdominal pain and other serious side effects. Essure is no longer on the market in the United States, but there are women who used the device for permanent pregnancy prevention and may still be at risk for painful or debilitating complications. If you or someone you love has suffered serious injuries or side effects that you believe to be related to Essure birth control, contact an experienced Essure injury lawyer today to discuss your legal options. You may be entitled to financial compensation for your injuries, which you can pursue by filing an Essure injury lawsuit against Bayer.
Essure is an implantable sterilization device intended to provide permanent pregnancy protection as an alternative to tubal ligation. The Essure implant contains flexible metal coils meant to be inserted through the cervix and vagina and into the fallopian tubes. The device causes scar tissue to develop around the coils, creating a barrier that keeps sperm from reaching and fertilizing the eggs, thereby preventing pregnancy. Bayer’s Essure birth control device was approved by the FDA in 2002 and implanted in more than 500,000 women in the United States.
The potential for Essure to cause serious complications in implant recipients has been evident for years. In February 2016, a black box warning was added to the Essure label, warning users about the potential for the birth control device to migrate out of position after implantation and perforate the fallopian tubes or uterus. By 2017, most countries had already recalled Essure, but Bayer continued to sell the birth control implant in the United States until the end of 2018. Essure sales were discontinued in December 2018, amid thousands of product liability lawsuits filed by women who reported experiencing painful and debilitating complications from the birth control device, including device migration, perforation injuries, persistent pain, abnormal bleeding, severe allergic or hypersensitivity reactions, and other problems. However, the device remained available for implantation in the U.S. until December 2019.
After Bayer announced that it was discontinuing Essure sales in the U.S., the FDA required the company to extend an ongoing Essure postmarket surveillance study from three years to five years and take other measures to continue evaluating the long-term safety of Essure after production and sales of the birth control device had been terminated. On July 8, the FDA issued a press release outlining the interim results of the Essure postmarket study, which appear to confirm a number of serious problems with Bayer’s recalled birth control device. According to the study results, women implanted with Essure reported experiencing a wide range of side effects, including chronic lower abdominal and/or pelvic pain, abnormal uterine bleeding, hypersensitivity and allergic reactions, autoimmune disorders or autoimmune-like reactions, and the need for invasive gynecologic surgery, including Essure removal.
“Today we’re providing important early overall results – from patients at varying points of follow up – from that prospective study to help patients and health care providers better understand complications women with Essure may experience,” said Terri L. Cornelison, M.D., Ph.D., director of the FDA’s Health of Women Program in the Center for Devices and Radiological Health, in the FDA press release. The postmarket study population included a total of 1,128 women who were at least 21 years of age and had chosen to undergo either hysteroscopic sterilization (Essure) or laparoscopic tubal sterilization. The results showed that 22.3% of women who received Essure suffered hypersensitivity or allergic reactions, compared to only 12.5% of women in the tubal ligation group. The study also indicated that 16.3% of Essure recipients experienced abnormal uterine bleeding and 9.1% experienced chronic lower abdominal pain or pelvic pain, compared to only 10.2% and 4.5% of tubal ligation patients, respectively. Furthermore, while Essure is meant to provide permanent pregnancy prevention, the postmarket study indicates that 14.3% of Essure recipients had the birth control device removed within the first 21 months after implantation.
“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,” said Cornelison. “Also, patients with Essure had higher rates of gynecologic surgical procedures – including surgery to remove Essure – than patients who had tubal ligation.” If you received an Essure birth control implant and you have experienced pain, abnormal bleeding or an allergic or hypersensitivity reaction, do not hesitate to seek legal help from a knowledgeable attorney with experience handling Essure injury claims.