FDA: Women Advised to Think Twice about Essure – Removing the Device Is a New Concern

FDA: Women Advised to Think Twice about Essure® – Removing the Device Is a New Concern

Since its inception in 2002, Essure® has been at the center of rampant controversy. The problems and injuries inflicted by this permanent birth control system have often given women no choice but to undergo a hysterectomy or to have the coil implant removed altogether.

But if Essure users thought they’d heard the end of the long list of risks associated with this form of contraception, they had better think again. The latest? Removing Essure might not be such a good idea after all.

Last month, a New York woman spoke out about her horrific experiences with the implant, and her hysterectomy and 2 surgical procedures that followed. She described how, even after a physician surgically removed the coils, her back pain and headaches continued – evidently because the doctor performed the removal incorrectly.

Since Essure was designed to be left in place permanently, manufacturers were not concerned with contingency plans. Hardly any literature on removing the device exists, and many doctors still aren’t aware of the device’s existence in the first place. Allegedly, some doctors have even resorted to “Googling Essure” before proceeding with removal to find out what to do.

That said, it doesn’t take much research for one to learn where Essure went wrong.

What Is Essure and How Is It a Problem?

Approved by the Food and Drug Administration (FDA), Essure proclaims to be “the only permanent birth control with a nonsurgical procedure.”

Originally meant to provide an alternative to tubal litigation (having one’s “tubes tied”), the procedure is relatively effortless and can be done in the patient’s doctor’s office. The Essure device is a small, springy coil that is inserted into each fallopian tube and prevents sperm from entering the uterus.

But the reality isn’t quite as simple as it sounds. Essure use is fraught with risks, from mild side effects to life-threatening injuries.

Just some of the symptoms women have reported experiencing include excruciating back or stomach pain, stiff joints, chronic fatigue, depression, changes in menstrual cycle, and allergic reactions. Some women’s implants have also ended up migrating to other parts of the body or piercing tissue. Others have even gotten pregnant, even though the product was marketed to be 99.83 percent effective at preventing pregnancy (and many who did conceive reported miscarriages and stillbirths).

These problems have often resulted with women having to incur surgery – which, of course, was exactly what they’d tried to avoid by opting for the “non-surgical” Essure in the first place. But 280 reports thus far have described complications with removing the device.

“You have a lot of doctors making mistakes removing them,” said Dr. Julio Novoa, an OB-GYN based in El Paso, Texas. If the coil is broken during removal – which can happen no matter how carefully the procedure is performed – it can leave behind tiny fragments that find their way to other parts of the body and cause even more damage.

It seems that removing Essure from the fallopian tubes needs to be taken just as seriously as its insertion. But only 30 physicians in the country have experience in removal. This, the New York woman comments, means women are left “hoping and praying that [the] physician does it right.”

Who Is to Blame?

Many argue that Essure’s original manufacturers, Conceptus, Inc., a subsidiary of Bayer, are wholly responsible for this mess. Not only did they rush the product onto the market, but they did so by using the test results of fraudulent clinical trials.

Yet Bayer’s continued ignorance toward the problem is arguably worse. The company publicly defended the device’s effectiveness earlier this year despite over 9,900 women coming forward about serious side effects at that time. These included 26 reports of death – including miscarriages, adult death, and infant death – but there may have been many more problems.

Bayer maintains that Essure is appropriate for most women. Said a Bayer spokesperson, Rosemarie Yancosek, who read about some victims’ personal experiences: “These stories, while compelling, are not representative of the hundreds of thousands of women who have relied on Essure since its FDA approval in 2002.”

Thousands of women have filed lawsuits against Bayer, while the FDA is at the same time sharing a portion of the blame for not taking more serious action than mandating stiffer warning labels.

Meanwhile, Congress is still fighting to take Essure off the market. The hope is that it’s successful in forcing the FDA to step in before any more women are affected by Essure in any way. But whether or not the bill is passed, says Dr. Diana Zuckerman, President of the National Center for Health Research in Washington, “It sends an important message that Congress is concerned about this product and is looking at what the FDA is doing.”

Sokolove Law Team

Contributing Authors

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Last modified: December 28, 2016