The Food and Drug Administration has announced that it will require Bayer to comply with new safety restrictions on the sale of Essure birth control implants. Under the new regulations, the sale of Essure will be restricted to doctors’ offices or other locations where women can be fully informed about the risk of side effects associated with the birth control device.
Essure is intended as an alternative to tubal ligation surgery for permanent birth control. Essure is comprised of two small metal coils, which are placed in the fallopian tubes through the vagina by a doctor. The metal coils around the device are designed to cause an inflammatory response at the site of implantation that causes scar tissue to form. This scar tissue is designed to block the fallopian tubes over a period of about three months, leading to permanent birth control.
However, since Essure was placed on the market by Bayer in 2002, the FDA has received thousands of complaints from women who suffered complications from the birth control device. In its announcement for the new safety restrictions, the agency announced that it had received more than 26,000 reports of complications related to Essure.
In 2016, the FDA issued a black box warning for Essure, stating that the device could cause severe injuries, including the perforation of the fallopian tubes or the uterus. The warning also stated that Essure could migrate to the abdomen or pelvic cavity after implantation, causing serious pain that could require the surgical removal of the device.
In February, FDA chairman Scott Gottlieb met with a group of women who had experienced complications from Essure. Many of these women called for the FDA to issue stronger warnings about the potential side effects of Essure, while others called for the agency to pull the birth control devices from the market.
Based on the testimonials of these women and other data gathered by the agency, the FDA announced that it would only allow Essure to be sold in doctor’s offices with the doctor’s signature. These doctors would be required to have patients sign a form acknowledging that they have been informed of the risk of side effects associated with Essure.
Product Liability Lawsuits Filed by Heygood, Orr & Pearson
If you or a loved one have experienced serious complications from the birth control device Essure or other medical products, you may eligible to take legal action over your injuries. The first step in determining whether you qualify to file a case it to speak with an experienced product liability attorney to learn more about your legal rights.
The lawyers at Heygood, Orr & Pearson have spent years holding drug companies and medical device manufacturers responsible for the injuries and deaths caused by their products. Our law firm has made it a career priority to hold drug manufacturers accountable and responsible for their actions. Heygood, Orr & Pearson has the resources and experience to protect your rights against irresponsible pharmaceutical companies and medical device manufacturers.
For more information about filing a lawsuit and to find out whether you may qualify, contact the lawyers at Heygood, Orr & Pearson for your free legal consultation. You can reach us by calling toll-free at 1-877-446-9001, or by following the link to our free case evaluation form and answering a few simple questions about your case to get started.