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In 2002, the Federal Food and Drug Administration (FDA) approved Essure. Essure was designed as a medical device to prevent pregnancies in women. Women are inserted with two of the devices, which resemble a coil, one in each fallopian tube, to assist the body in creating a natural blockage in the tubes in order to permanently prevent pregnancy. It has been touted as an easier procedure than tubal ligation, where a woman must undergo anesthesia and incisions. The procedure for inserting Essure is done without anesthesia in a doctor’s office, and women are able to resume activities that same day.
In recent years, the FDA has been receiving numerous complaints about side effects associated with the device. These have included debilitating pain, hair loss, and severe allergic reactions to nickel in the product. Other women have complained that they had unintended pregnancies after the insertion of the device. Some women have even complained about dental problems or the device poking through the uterus.
Some women have reported that Essure has migrated over time, or caused perforations, and that these incidents could cause unwanted pregnancies or other side effects. Many women have stated that the only way to obtain relief from the side effects of the device was to have a full hysterectomy.
Women who have felt that they have experienced adverse side effects from Essure are now forming groups on social media to share their stories, and also to organize demonstrations and panels that have testified before the FDA.
Although the FDA has received thousands of complaints regarding Essure, the device is still on the market. But after years of inaction, the FDA has implemented some changes.
In 2016, the FDA began to restrict the sale of the device, and began to require extra knowledge on the part of doctors who insert the device. The FDA required doctors to give a checklist to patients of the potential risks involved with Essure. Therefore, there are still patients who are receiving Essure implants today, but not without some warning of potential issues.
Even though the FDA did extensive testing on the device before it went to market in 2002, some doctors feel that the true effects of any medical device cannot be fully discovered until the device has been in use for about ten years. Making the decision to obtain a medical implant device is one that should not be taken lightly.
Although medical devices can vastly improve people’s lives, if the device is defective, or all of the relevant side effects are not yet known at the time of implantation, a patient can suffer significant injuries, including death. If you or someone you know has been hurt by a medical device, contact one of our Philadelphia medical device lawyers at Brookman, Rosenberg, Brown & Sandler for a free consultation. Call us at 215-569-4000 or contact us online. We are centrally located in Philadelphia, Pennsylvania, and we represent clients throughout the surrounding areas.