Manufacturer, FDA Warn Women Of Possible Essure Risks
NASHVILLE, Tenn. - This past summer, NewsChannel 5 Investigates first exposed some of the problems women have been having with a relatively new form of birth control. Now it appears both the manufacturer of Essure and the federal government have taken notice.
Eva Noss told NewsChannel 5 Investigates back in July, "I was getting headaches a lot."
She said she experienced often unbearable pain caused by her birth control.
"It just felt like somebody was just stabbing you in your lower abdomen. My cramps from my menstrual cycle literally went from mild to extreme," she said.
Noss had had Essure coils implanted in her fallopian tubes that were supposed to cause scar tissue that would seal her tubes and prevent pregnancy.
But Noss and hundreds of other women complained that Essure also causes extreme side effects. And the number of complaints we have found has jumped significantly since our initial investigation.
854 women had filed complaints with the Food & Drug Administration about Essure between the time it was first approved 11 years ago in November of 2002 and when our first story ran this summer towards the end of July.
After our investigation and the additional media coverage that followed, the FDA got more than 300 additional complaints through the end last month, bringing the total number of complaints to 1162.
Among the new ones, we found a report that an Essure patient died from an infection. According to the adverse event report, the woman went to the emergency room complaining of abdominal pain. Doctors found her cervix, fallopian tubes and uterus, necrotic, meaning the tissues had died. Bayer, the company that makes Essure, told the FDA that her death was not directly related to its product or procedure.
But the company is now taking steps to warn women of other possible risks.
Among the top complaints to the FDA about Essure are chronic pain and migration of the device, in other words, the coils have fallen out of the tubes.
But Essure's patient information booklet does not mention these as possible side effects. Bayer now has received permission from the FDA to add additional warnings, letting women know that Essure can cause chronic pelvic pain and that there is a risk of device migration.
The company told NewsChannel 5 Investigates in a statement, "Patient safety is of utmost importance to Bayer. We continuously review the information available about our products and, when appropriate, we work collaboratively with the FDA to update the information available to patients and physicians."
Back in July, consumer advocate Erin Brockovich told NewsChannel 5 Investigates how she had set up a website for women who'd had problems with Essure.
"I got involved because so many women were coming to me that had problems with Essure," Brockovich explained.
She said then that she'd already heard from more than a thousand women. Now, her website said that our story led to a substantial surge of women coming forward to share stories and experiences with Essure.
"There may be something wrong with the product...Let's look at these women's story. Is it a bad product? And if it is, let's remove it until we fix the problem and make it right for the potentially thousands of women who have been harmed," Brockovich said.
Bayer says some 750,000 women have had the procedure while the FDA says its own studies have found no widespread problems. However, the agency says it "will continue to monitor the safety of Essure to make certain that its benefits...continue to outweigh its risks."
The FDA encourages women who have had problems with Essure to file a complaint. You can do that HERE.
Meanwhile, the FDA gave Bayer permission to add the new warnings in late October, but the company still has not changed its patient guide yet. Bayer says it's still updating the information.