Posted on Tuesday, August 14th, 2018 at 9:50 pm
On Friday, July 20, Bayer AG, a German pharmaceutical and chemical company, announced it will cease selling its Essure medical device. Unsurprisingly, Bayer’s announcement was termed a “business decision” due to declining sales rather than the safety and efficacy of the device. In fact, Bayer cited “inaccurate and misleading publicity” as the primary reason for its decommercialization of Essure.
While the Essure device is itself unique, its tortured history is not unlike many implanted contraceptives that came before it. Indeed, the suffering of nearly 1 million women caused by the Dalkon Shield IUD in the 1960s and 70s served as the impetus for Congress’ passage of the Medical Device Amendments of 1976 (“MDA”). The MDA established for the first time comprehensive federal pre- and post-market regulation of medical devices.
What is the Essure Device?
- Essure is a small, metal spring-like device wound with synthetic fibers designed for implantation in the fallopian tube to create a barrier of scar tissue to block sperm from reaching eggs.
- Essure was developed by Conceptus, Inc., and FDA approved by the FDA in 2002. Bayer AG purchased Conceptus, Inc. in 2013, including the rights and liabilities associated with sales of Essure.
- Since approval, the FDA has received nearly 30,000 reports of serious complications associated with the device, including migration and perforation of the device through tissue and organs, severe autoimmune response (fatigue, hair loss, weight gain), chronic pain and even death.
- In 2015, the FDA held a public meeting with OB/GYN experts, concerned citizens and women injured by Essure.
- In 2016, and due to continued complaints of complications and injury, the FDA required Bayer to conduct a clinical trial to test the safety and efficacy of Essure.
- In October of 2016, the FDA demanded that Bayer add a “black box” warning to the Essure device.
- In April of this year, FDA Commissioner Scott Gottlieb took the unprecedented step of imposing “unique” restrictions on the sale of Essure, including limiting the sale of the device to physicians who agreed to employ a “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement,” to ensure that the risks associated with the device were presented to prospective users prior to implantation.
What Do You Do if You Have Been Implanted with or Injured By Essure
- Talk to your doctor to make sure you fully understand the risks of the device
- If you’ve been injured by the device, consider seeking legal assistance now as your claim may be subject to strict time limits.
By Nate Vanderveer