Essure is a small metal coil that’s placed in the fallopian tubes via catheter. The FDA said last year that in the 13 years since Essure’s approval, the agency had received 5,093 complaints, including for pain or menstrual irregularities after using the device, and complaints of the device breaking. In addition to 5 fetal deaths, there were 4 reports of adult deaths for reasons such as infection and uterine perforation, the FDA said.
The plaintiffs are seeking judicial actions requesting an expert to determine the relationship between the device and the patients pathologies, according to their representative Charles Joseph-Oudin.
The action has prompted the French Health ministry to say that checks carried out since last year show that the problems were linked to the way the Essure devices were inserted, and not the device itself.
“The investigations demonstrated that the medical complications that have been observed originated from the way the device was implemented,” the ministry said, adding the product itself was sound.
Legal counsel for the women in the case is hopeful that hearings will take place as soon as January.
Approximately 120,000 women in France has used the device since 2002, with reported side effects of depression, dizziness and uterine perforation, according to French newspaper Le Parisien.
In November, the FDA released new labeling requirements for Essure other permanent hysteroscopically-placed tubal sterilization implants.
Updated guidelines from the FDA will require a patient checklist to avoid possible adverse events and a boxed warning as labeling for these devices from now on, according to releases posted this week by the federal watchdog.
The FDA mandated a new study and new labeling of the device earlier this year.
In August, the FDA said it completed a review of a trade complaint which alleged that Bayer was engaged in clinical trial misconduct and altering data, saying it found no signs of manipulation.
Material from Reuters was used in this report.
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