France’s national health agency has created a special panel of independent medical experts to review the benefit – risk profile of Essure, Top Santé reports. Women around the world say the birth control implant, a product manufactured by German healthcare conglomerate Bayer, leads to debilitating pain, abnormal menstruation and a host of other adverse side effects.
French Experts Convened To Review Essure Safety
A growing group of US Essure patients is attempting to hold Bayer accountable for these alleged health risks. In fact, hundreds of women have already filed personal injury lawsuits against the company, saying more could have been done to warn the public and healthcare providers.
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In 2016, the US Food & Drug Administration took matters into its own hands, telling Bayer to strengthen the contraceptive device’s warnings. Reactions overseas, though, have been more cautious. While Brazil has now issued a total market recall for the implants, no other country has taken a firm stance on the device’s potential dangers.
A recent decision made by French regulators could change that. On Wednesday, April 13, 2017, the nation’s National Agency for the Safety of Medicines and Health Products announced the creation of a Temporary Specialized Scientific Committee. Over the coming weeks, this panel of independent medical experts will review the safety and efficacy data behind Essure, in an attempt to determine whether the device’s health risks are adequately balanced by its contraceptive benefits.
Committee Will Review Side Effects, Patient Experiences
The committee is expected to convene on Wednesday, April 19, when various “stakeholders” assemble to discuss statistical data and major studies, along with hearing testimonials from patients and physicians. France’s National College of Gynecologists and Obstetricians and National Association of Abortion and Contraceptive Centers are expected to participate, according to Top Santé.
Leaders from R.E.S.I.S.T., a French support and advocacy group for women who believe they have suffered Essure-related side effects, will attend to represent the interests and experiences of patients.
Media reports indicate that the panel’s recommendations could be released within a matter of weeks.
French Patients Sue Bayer, Call For Essure Recall
It’s unclear how many French women have actually received Essure implants. In 2016, media outlet Ouest France reported that around 120,000 women in France had undergone implantation procedures since the device was introduced to the market in 2002. A more recent article suggests that up to 240,000 Essure units have been sold in the country. Blog Rue89Lyon stakes out a middle-ground, writing that 170,000 French women have received the implants over the last 15 years.
A petition calling for the country’s health and safety watchdogs to recall the contraceptive has already received over 75,000 signatures. Only three French women, however, have thus far chosen to file lawsuits against Bayer, according to Paris-based attorney Charles Joseph-Oudin. More litigation is expected in the future. Joseph-Oudin, who is working to develop the case for plaintiffs, says that around 30 other patients are preparing to file Essure lawsuits against Bayer in France.
More Study Results Expected Soon
Meanwhile, patients and doctors across the world eagerly anticipate the results of SUCCES II, a Bayer-sponsored clinical trial that focused on the experiences of Essure patients at one French hospital. Conducted at the Hôpital André Mignot Centre Hospitalier de Versailles, a hospital in the suburbs of Paris, SUCCES II was established to review the “satisfaction” of patients who undergo successful implantation procedures over the course of five years. While the trial is listed as “complete” on ClinicalTrials.gov, no results have yet been posted.
More studies have also been ordered in the US, including an FDA-mandated research project on the device’s long-term effects that will focus on sub-groups of patients who may be at an increased risk of experiencing side effects. The analysis is crucial, according to Dr. William Maisel, chief scientist at the FDA’s Center for Devices and Radiological Health. “More rigorous research is needed to better understand if certain women are at heightened risk of complications,” Maisel told reporters at US News & World Report.