The High Court of Spain, the Audiencia Nacional, has opened a criminal case against Bayer, the Spanish Gynecology Society and the Spanish Medicine Agency (Aemps) after receiving a series of complaints relating to the damage of the Essure contraceptive. The decision of the Spanish court comes after that in United States and the sale of the contraceptive has been banned in Europe.
Sold by Bayer, Essure is a permanent birth control implant that is surgically inserted into a woman's fallopian tubes. The metal coil causes fibrosis, which acts as a barrier to prevent sperm from reaching the ovaries. Bayer is facing nearly 16.000 lawsuits against Essure in the United States while in France a class action is pending.
The private criminal charge was initiated in early July by the Essure Victims Association on behalf of 30 women, who reported public health crimes. This group claims that women were not deliberately informed about the health risks of the product. According to lawyers, “patients have never been adequately informed of possible product-related complications that could affect their health. This is an intentional omission".
The women claim that Essure caused it continuous pain, bleeding, vomiting, diarrhea, hair and tooth loss and tearing of the uterus and fallopian tubes. "They have lost their reproductive organs," comments lawyer Francisco Almodóvar, "becoming completely sterile" while those to whom the fallopian tubes have been removed can only become pregnant through insemination in vitro.
Bayer, one of the most powerful pharmaceutical companies in the world, has gradually taken Essure out of the global market. Last year, the company stopped distributing in Spain, but claimed that the decision was not related to complaints about its safety. In a press release published in September 2017, Bayer claimed that the move was "for commercial reasons," claiming that demand for the product in Spain had "drastically decreased".