In July 2018, Bayer Pharmaceuticals announced that its permanent birth control device Essure would be removed from the market by 2019. The company has already stopped sales outside of the U.S. The company cites declining sales as the reason to pull it from the domestic market. The product has received numerous reports of adverse effects, however, and is now facing thousands of lawsuits.
Essure was first made available for sale by Conceptus Inc. in 2002. It was marketed as the first permanent method of birth control that did not require surgery. Instead, the two small flexible coils are inserted vaginally into the fallopian tubes. Scar tissue develops around the coils as they expand over the next few months, blocking the sperm from ever meeting an egg. The only other option to permanently prevent pregnancy is laparoscopic surgery, which is minimally invasive but still requires an incision and was thought to be a good solution for patients who could not undergo abdominal surgery.
FDA Tightens Safety Requirements
Between 2002 to 2005, the Food and Drug Administration (FDA) received more than 5,000 complaints from women who used the device. The complaints included reports of pain, bleeding, and unintended pregnancies, some of which ended in miscarriage or still birth. Bayer acquired Conceptus in 2013; as of April of 2018, the company was facing 16,800 lawsuits relating to Essure and its marketing, compared to just 3,000 in October 2016. The FDA has required added safety warnings on the device, along with a checklist outlining potential side effects that both the doctor and patient must sign once they have discussed it.
Some physicians claim that the issue is not with the device, but with the procedure. The insertion of the device requires the use of surgical cameras and precise placement of the coil where it is visible and will not damage the fallopian tube. If it is not inserted properly, injuries such as perforation of the wall of the uterus or fallopian tube can occur.
Despite assurances of its safety, thousands of women who received the device are speaking out about their injuries. There are numerous Facebook groups for victims sharing their experiences, some of whom have experienced debilitating abdominal pain, severe bleeding, or tears in the uterus or fallopian tubes. Depending on the severity of the damage, some women have had to undergo complete hysterectomies in order to make a recovery.
New Jersey Medical Product Liability Lawyers at Eichen Crutchlow Zaslow, LLP Advocate for Victims of Defective Medical Devices
Medical devices with an inherent flaw or defect can have devastating effects on patients. If you or a loved one has suffered harm due to a medical device, the medical product liability lawyers at Eichen Crutchlow Zaslow, LLP can help. We will thoroughly review the facts of your case and hold those responsible for your injury accountable. With offices conveniently located in Edison, Red Bank, and Toms River, we help victims of defective medical devices throughout New Jersey. Call us today at 732-777-0100 or contact us online for a free consultation with a New Jersey medical product liability lawyer.