“Essure” is a small metallic coil-shaped birth control device which is permanently inserted into each fallopian tube. The resulting inflammation and scar tissue build-up thus creates a barrier, which theoretically provides permanent female sterilization.
Numerous adverse side-effects have been reported including device migration, organ perforation, and persistent pain. In December 2016, two patients filed lawsuits, and apparently more than 30 other claims are currently being established against Bayer who markets this implant in France. In response, the French Health Products Safety Agency has named a Temporary Specialized Scientific Committee with multidisciplinary independent experts to establish a report comparing the benefits and risks of the device.
In this context, several groups have been auditioned, such as the “R.E.S.I.S.T.” association (a network to support and provide information on tubular sterilization), who has requested by precaution that women do not have the device implanted. In France, 1200 women having been implanted with the device have joined this association in order to obtain answers. This allows them to exchange information and testimonials on the secondary effects of this tubular sterilization device and to compile the results of a questionnaire carried out among the members. In the USA, women who have been victims of adverse side-effects have joined a Collective Group. The FDA (Food and Drug Administration) has already received 9,970 adverse event reports associated with the use of Essure.
Family Planning and the National Association of Abortion and Contraception Centers were also auditioned, who requested for the device to be taken off the market.
The French National College of Gynecologists and Obstetricians also spoke during these hearings. The gynecologist, Dr. Olivier Graesslin, suggested that the x-ray performed 3-months post-insertion should automatically be backed up by a sonogram. He also suggested implementing “a specification sheet” for removing Essure and a directory of “expert” gynecologists throughout France.
According to the French Medical Drug Agency, 140,000 Essure devices have been sold in France since 2011, an average of over 20,000 per year. France represents 40% of the worldwide market for this implant.
On April 19, 2017, the same agency reported in a report that over 1000 French women have experienced problems with the device or the appearance of adverse side-effects between 2003 and February 2017.
During the insertion procedure, 682 problems were noted (breakage or non-functioning of the small coil-shaped device…), whereas 457 incidents occurred at a later date. Among the problems following implantation, 138 were mechanical (device migration, organ perforation…), 249 were gynecological (bleeding and abdominal pain) and 281 of different nature (other kinds of pain, extreme fatigue, allergic reactions, depression…). Forty women also reported becoming pregnant after receiving an Essure implant.
The director of medical therapeutic devices at the French Medical Drug Agency, Brigitte Heuls, recognizes that these statistics for dysfunction and adverse side-effects may be underestimated, since they are based uniquely on the incidents reported to the agency. Therefore, she emphasized the evaluation of the device “demonstrates some limitations”.
For the lawsuits currently in progress, the decision from the judge of the High Court in Bobigny (Seine-Saint-Denis) is expected by May 5th.
At the end of their evaluation, the Temporary Specialized Scientific Committee will give their recommendations which will be published in the coming weeks.
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Notes :
Temporary Specialized Scientific Committee
