FDA responds to concerns about Essure

Posted at 11:26 PM, Feb 29, 2016
and last updated 2016-03-01 07:00:23-05

The FDA responded to concerns thousands of women have raised about life long health problems from the controversial birth control device, Essure. 

Even before the FDA’s ruling, Kimberly Hughes told ABC2 there was no need for further studies. The mom from Prince George's County  believes she and her e-sisters are living proof of the damage Essure can cause.

See also: Women claim birth control procedure causing health problems for many women

"Extreme exhaustion, chronic pain, changes in my period," Hughes said. "It would last half the month.  It was extremely heavy.  I couldn't go places where I couldn't get to a bathroom."

Ultimately she had a hysterectomy at 38. Her story has been echoed by thousands of women on the Essure problems Facebook group.

Two coils are implanted into the fallopian tubes to block pregnancy, but it opened the floodgates for some women having many other problems.

"Two years into it, I was bleeding every day for 30 days straight.  I made a doctor’s appointment and they found my coils in my uterus," Hughes said.

But even after listening to stories like Hughes' and experts back in September, the FDA wasn't convinced enough to pull the permanent birth control device off the market.

Related: New, stronger FDA warning for Essure birth control implant

Monday they offered recommendations. The statement reads in part,

These actions include a new, mandatory clinical study for Essure to determine heightened risks for particular women and draft guidance with labeling recommendations including a boxed warning label and......a checklist for doctors to discuss potential risks of implanted permanent birth control devices with patients

Pennsylvania Congressman Michael Fitzpatrick blasted the FDA. In November he proposed the E-free Act to get Essure pulled off the market. 

Fitzpatrick released a statement saying if the FDA doesn't act then Congress must.

  • Continue my call for the house and senate to take up and pass the e-free act to revoke the FDA approval of Essure
  • Work to block government agencies - such as the DOD and VA - from purchasing this unsafe device; and
  • Introduce new legislation to eliminate the blanket civil liability protections