On July 20, 2018, Bayer announced they would be halting the sale of the Essure birth-control device in the U.S. by the end of the year. An estimated 750,000 devices have been sold, mostly in the United States.
The device, designed to cause sterilization, was approved by the FDA in 2002 and was deemed a nonsurgical alternative to tubal ligation. It was developed by Conceptus Inc. in California and acquired by Bayer in 2013. Essure consists of two-inch-long flexible coils made from nickel and titanium.
Thousands of woman blame the implant for serious health problems including persistent pain and perforations of the uterus and fallopian tubes, autoimmune problems, unintended pregnancies, and migration of the device into the pelvis or abdomen. Some have had to have the device surgically removed.
In 2016, the FDA forced Bayer to add a black box to the product’s label, its most serious warning, and directed Bayer to create a three-page checklist for prospective users prior to implantation; however, many women were still not adequately warned about the risks and potential problems. In April, they imposed a restriction that limited sales to doctors who guaranteed their patients were being told about the risks.
Bayer stands by the safety and effectiveness of the device, even after having been served with lawsuits representing over 16,000 patients. They are claiming they’re removing the product because of a significant 40 percent decline in sales in recent years. They attribute this decline to a decrease in the number of women who want permanent contraception because of reliance on long-acting reversible contraception, and because of inaccurate and misleading publicity.
Some opponents to the device are equally as mad with the FDA for approving a device without adequate studies. The United States is the last country where Essure can be purchased and used. Last September, Bayer announced the ending of sales outside of the United States.
If you have used the Essure permanent birth control system, are experiencing complications, and believe you have a case against Bayer, our Omaha product liability lawyer is prepared to represent you. Contact us today for a free consultation.