Bayer Will Halt the Sale of Essure Following Injury Claims
The birth control device Essure sparked thousands of lawsuits brought by women who say they were harmed by it. Now its maker Bayer has announced it will halt the sales of Essure.
Essure is an implant. It is linked to terrible injuries and is the subject of mass litigation.
Thousands of women blame this device for perforations of the uterus and the fallopian tubes, severe ongoing pain and a host of other complications.
A report in the Washington Post at the end of last month revealed Bayer will halt the sales of Essure. However, the company did not link its decision directly to the lawsuits. In a statement, Bayer said it stands by the safety and effectiveness of the device and said women can rely on it.
Bayer linked its decision to declines in sales in recent years. However, it appears to our Virginia dangerous medical device lawyers the fall in sales is likely linked to the complications associated with Essure.
The United States is the last country where Essure is still sold. Last year, Bayer announced it was ending sales outside the United States. It again cited “commercial reasons.”
What is Essure Birth Control?
Essure is a birth control device that causes sterilization. It comprises two inch-long, flexible coils partially made from an alloy of nickel and titanium. A doctor inserts the coils into the fallopian tubes, which carry eggs from the ovaries to the uterus. Scar tissue is supposed to form around the coils within three months, creating a barrier that keeps sperm from reaching the eggs.
Some women who have taken Essure claim it failed to prevent pregnancies. Many others reported serious complications.
What Complications Are Associated With Essure Birth Control?
Women have reported a host of serious issues with Essure birth control including:
- Device fracture causing damage to nearby tissues;
- Migration of the devices out of the fallopian tubes into the uterus or pelvis
- Organ perforation when the coils puncture the fallopian tubes, uterus or bowel;
- Autoimmune problems.
In extreme cases, Essure was linked to the deaths of women. In many other cases, women have had to have operations to have the devices removed.
The Post spoke to Angie Firmalino, a leader of the fight against the device who celebrated Bayer’s decision to pull Essure off the market.
Firmalino had the device inserted in 2009. From the outset she started having pain and bleeding. She learned the coils had migrated to her uterus and had a hysterectomy. Two years later, she started the Facebook group “Essure Problems,” which has 37,000 members and pressed the U.S. Food and Drug Administration (FDA) to ban Essure.
The device was approved by the FDA in 2002. It was hailed at the time as a nonsurgical alternative to tubal ligation, the process commonly called having “tubes tied.”
It was manufactured by Conceptus Inc., a medical manufacturing company based in California which was acquired by Bayer in 2013.
In recent years, reports of serious injuries and complications linked to Essure led the FDA to issue warnings. Two years ago, the FDA issued a “black box” warning to the product’s label. This is the most serious warning available.
In April, the FDA issued an almost unprecedented restriction on the sale of Essure. It limited sales to doctors who guaranteed recipients were told about the dangers of the device. The FDA said Bayer would be held liable for implementing the requirement.
The restriction appears to have heralded the beginning of the end for Essure. More than 17,000 lawsuits have been filed against Bayer over injuries, complications and deaths linked to Essure.
The history of Essure appears to be yet another example of big pharma putting a product on the market and waiting until thousands of people have been hurt before pulling it. The episode again highlights the slowness of the FDA to react as reports of illnesses piled up.
Ms. Firmalino and many other women experienced extreme pain, complications and corrective surgery almost a decade ago. Yet, the product remained on the market for more women to fall ill and even lose their lives.
At Cooper Hurley Injury Lawyers, we are devoted to fighting for consumers who are injured by big pharma’s relentless drive to make money. We are pleased Bayer will halt the sale of Essure but the company should have taken action far sooner. It’s not too late to join a lawsuit over Essure, but you should act fast. Call us today at (757) 455-0077.