PARIS (Reuters) - Women in France who have used Bayer’s contraceptive implant Essure have launched a legal complaint about side-effects similar to a challenge already underway in the United States.
A Bayer spokeswoman declined to comment on litigation in France but said the company remained convinced that the implant was a good option for many women and that it offered a positive risk-benefit profile.
Thousands of complaints about the device in the United States in March prompted regulators to put the strongest safety warning label on the product and ask for a post-market study.
The latest legal action prompted the French health ministry, under pressure after a number of health scares, to say checks carried out since last year have shown Essure-related problems to be linked to the way some devices had been inserted, not to the device itself.
Charles Joseph-Oudin, who represents two plaintiffs, told Reuters: “We are launching two judicial actions and we are asking that an expert determine the relationship between the device and the pathologies patients have been experiencing.”
He said he hoped the filings on Friday would lead to hearings in a tribunal near Paris as soon as January.
The device, promoted as an alternative to tubal ligation for permanent birth control, consists of two small nickel-titanium coils inserted into the fallopian tubes. Scar tissue that forms around the coils is meant to prevent pregnancy.
Bayer estimates about 750,000 women are using Essure worldwide, about 70 percent of them in the United States. France is the product’s second-largest market but Bayer does not provide more precise figures.
The company said in its third-quarter report that U.S. lawsuits from approximately 3,000 Essure users were pending.
French newspaper Le Parisien, which earlier reported the lawsuits, said some 120,000 women had been using the device in France since 2002 and that reported side effects had included depression, dizziness or uterine perforation.
The French health ministry said checks over Bayer’s product had started in July 2015.
“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.
However, Bayer had to rewrite the Essure leaflet and stricter rules over the way the device should be implemented have been imposed, the ministry added.
Additional reporting by Ludwig Burger; Editing by Ruth Pitchford