Bayer announced on Friday, July 20 that it will stop selling the birth control implant Essure by the end of 2018.
This controversial device has been mired in legal trouble for years, and thousands of women across the United States have filed lawsuits claiming that the metal implant caused serious injuries like perforated fallopian tubes and uteruses.
The Food and Drug Administration (FDA) required the multinational pharmaceutical and life sciences company to fully inform women about the potential risks of its product after meeting with advocates in April of this year. At the same time, the FDA reported that it received almost 27,000 reports of adverse events caused by Essure from 2002, when the product was first approved through 2017. However, this number may not cover the full extent of the damage one former FDA official, Madris Tomes, said the figure may be closer to 30,000.
“With side effects ranging from hair loss and tooth loss to chronic pain, severe bleeding, miscarriages and even death, the benefit risk profile touted by Bayer simply didn’t jibe with the data that was pouring into the F.D.A. from both patients and physicians,” Tomes, who now runs a company that analyzes adverse event data said.
The FDA ordered Bayer to place a “black box warning” on this product’s packaging warning potential consumers about the potential damage is could cause, including a note stating that the implant could migrate to the pelvic cavity and into the abdomen, which could require surgery to remove.
For more information about Essure and its potential dangers, visit our Essure page.
If you were suffered a serious injury because of a faulty medical device, contact Bailey Cowan Heckaman PLLC today. Our Houston medical device injury lawyers have spent decades working with countless clients, and through our efforts in the courtroom and at the negotiation. Fill out our online form today to schedule a free consultation with a member of our firm, or give us a call us to discuss the details of your case over the phone.