An El Cajon woman is one of 73 plaintiffs in a lawsuit filed in San Diego Superior Court against the Bayer Corporation. The major pharmaceutical company is being sued over their permanent contraceptive device, Essure.
The product, approved by the FDA in 2002 and touted as a safe alternative to surgery, is a pair of flexible coils that is placed in the patient's fallopian tubes. The coils generate scar tissue which then block the tubes and prevent pregnancy. However, in recent years thousands of women have complained about adverse side effects including fatigue, loss of hair, bleeding, and dental decay. In some more severe cases the tube migrated from the fallopian tubes and lacerated other organs.
In response to the complaints, as reported in a July 2017 Washington Post article, the Food and Drug Administration suggested that doctors advise patients of Essure's risks.
The response, says a Facebook group named "Essure Problems," was insufficient.
"The [Food and Drug Administration] has failed the women it is supposed to protect when it comes to the Essure device. The [Food and Drug Administration] issued a 'guidance' instead of a mandate, which means that they 'suggested' doctors share the new safety warnings with their patients, however we have the proof that this is not happening."
Now comes a new lawsuit against the Germany-based pharmaceutical company, this one to be heard in a San Diego County courtroom.
The El Cajon resident, Sara Elias, had the Essure device implanted in 2008. According to the complaint, her physician failed to advise her of the dangerous side effects. If they had, she claims she would not have made the decision to undergo the procedure. Instead, soon after having the implant, Elias says she began to suffer from pain in the abdomen and pelvic region. She also experienced abnormal bleeding and cramping. In 2012, physicians removed the coils.
Elias is the only San Diego County resident named in the lawsuit.