I-Team: Side effect claims made about popular birth control drug Essure
RALEIGH (WTVD) -- Essure, a popular form of birth control, was marketed in 2002 as a permanent birth control without surgery. But, according to the Food and Drug Administration, more than 4,700 doctors and women have made claims that the product has led to severe side effects.
Merari Lopez is from Wisconsin. She traveled to Raleigh to have Essure removed. She told the I-Team the side effects from the birth control device were too much to handle.
"There was severe pain," she said. "It was so severe that I could not get up out of bed."
Essure is a small metal coil inserted into the very beginning of the fallopian tubes. It causes scar tissue to form when the tubes close preventing pregnancy.
The I-Team found reports in the FDA database from women claiming side effects ranging from severe headaches and blood clots, to the devices cutting into other organs.
According to the FDA, seven deaths are reportedly linked to the device.
Dr. Charles Monteith is a gynecologist and obstetrician in Raleigh and one of the few doctors in the country who removes Essure from women's bodies.
"Unfortunately, a lot of women are getting hysterectomies to treat Essure related complications," Dr. Charles Monteith said.
Monteith implanted Essure in women for many years, but stopped when he began experiencing problems.
"I couldn't insert the devices at all," Monteith said. "The worst case scenario was that I could only insert one side but not the other side and that would be incomplete."
The I-Team learned that a group of women affected by Essure met with Food and Drug Administration officials in Washington last April to express their concerns with the birth control device. The FDA has been investigating Essure and plans to hold public hearings on the issue.
Bayer Healthcare makes Essure. On its website, the company says "Essure is over 99% effective at permanently preventing pregnancy."
But some women claim they still got pregnant.
A lawsuit filed in Philadelphia accuses Bayer of intentionally misleading women implanted with Essure.
The lawsuit states Essure "should never have been marketed or sold to the woman who filed the suit."
The lawsuit claims the coils placed in the plaintiff led to five hospitalizations, a hysterectomy, and auto-immune and adhesion disorders.
The I-Team reached out to Bayer for a comment about the complaints, the company told us:
"Patient safety is our top priority ... 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."
Click here to read the entire Bayer statement (.pdf)
On its website, the company claims approximately 750,000 women use Essure to prevent pregnancy.
Although most of the side effects reported are mentioned in the device's insert pamphlet, Dr. Monteith believes more should be done.
"I think the warnings need to be strengthened on the device," he said.
Dr. Monteith wrote a letter to the FDA asking for the agency to reevaluate the product. The FDA has invited him to its next hearing to express his views.
Like Dr. Monteith, Merari Lopez wants the product off the market and hopes to inform more women about the dangers of it.
After having the Essure device removed, Merari says she feels much better and is now pain free, but she'll never forget how she felt before.
"You don't feel like a woman any more with Essure," Lopez said. "Your hormones go completely haywire. I just think it's the worst feeling ever."
For more about the claims about Essure, visit these websites:
https://www.facebook.com/groups/Essureproblems/
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/ucm371014.htm
