FDA petitioned to stop sales of essure implant

May 5, 2015

FDA petitioned to stop sales of essure implant
(HealthDay)—Bayer's contraceptive implant Essure can cause serious complications and should be taken off the market, says a citizen's petition filed with the U.S. Food and Drug Administration.

The FDA approved Essure about 13 years ago after a review process that was fast-tracked because the device was the first alternative to surgical sterilization for women who did not want more children and offered patients a quick recovery, The New York Times reported.

However, since approving Essure, the FDA has received more than 4,000 reports of serious complications, including severe back and pelvic pain, coils that pierced the fallopian tubes and lodged in other organs, and heavy prolonged menstrual periods, The Times reported.

Thousands of women who say they were seriously injured by the implant want the FDA to take Essure off the market and to issue a public warning about its complications. Both the FDA and Bayer say the device's benefits outweigh the risks, The Times reported.

Explore further: Bayer to pay $1.1B for California firm Conceptus

More information: Health Highlights: May 4, 2015
More Information

Related Stories

Bayer to pay $1.1B for California firm Conceptus

April 29, 2013
(AP)—German drug company Bayer AG says it has agreed to buy California-based Conceptus for around $1.1 billion to expand the kinds of birth control it offers.

Women report complications from Essure birth control

December 26, 2013
Angie Derry knew that her Essure implants were designed to remain inside her body forever. But two years after a doctor inserted the tiny coils into her fallopian tubes to prevent pregnancy, the Rockford, Ill., woman wants ...

Watchdog group seeks FDA ban of antifungal tablets

February 24, 2015
(AP)—A consumer safety group is calling on the Food and Drug Administration to pull certain antifungal tablets off the market, saying there are safer medicines that do not carry risks of liver damage.

Advocacy group seeks ban on pelvic surgical mesh

August 25, 2011
(AP) -- A consumer advocacy group is calling on government regulators to ban a type of surgical mesh used to treat pelvic collapse, saying it exposes patients to serious risks.

FDA: generic copaxone approved for multiple sclerosis

April 17, 2015
(HealthDay)—The first U.S. generic version of Copaxone (glatiramer acetate injection) has been approved by the Food and Drug Administration to treat multiple sclerosis.

FDA orders safety studies of women's surgical mesh

January 4, 2012
(AP) -- The Food and Drug Administration is ordering medical device manufacturers to study safety complications with surgical mesh widely used to repair women's pelvic problems.

Recommended for you

Health insurer policies may discourage use of non-opioid alternatives for lower back pain

October 5, 2018
Public and private health insurance policies in the U.S. are missing important opportunities to encourage the use of physical therapy, psychological counseling and other non-drug alternatives to opioid medication for treating ...

Opioid overdoses, depression linked

October 3, 2018
The link between mental health disorders and substance abuse is well-documented. Nearly one in 12 adults in the U.S is depressed, and opioid-related deaths are skyrocketing. As these numbers continue to climb, some mental ...

Do price spikes on some generic drugs indicate problems in the market?

October 1, 2018
A new USC study reports that sudden price spikes for some generic drugs—such as the recently reported increases of a decades-old generic heart medication and an antibiotic—are becoming more common.

Reclassification recommendations for drug in 'magic mushrooms'

September 26, 2018
In an evaluation of the safety and abuse research on the drug in hallucinogenic mushrooms, Johns Hopkins researchers suggest that if it clears phase III clinical trials, psilocybin should be re-categorized from a schedule ...

New study finds concurrent use of prescription drugs and dietary supplements could pose health risks

September 25, 2018
A new University of Hertfordshire study found that using certain over-the-counter herbal medicines and dietary supplements alongside prescription drugs could pose serious health risks, especially amongst older adults.

Drug overdose epidemic has been growing exponentially for decades

September 20, 2018
Death rates from drug overdoses in the U.S. have been on an exponential growth curve that began at least 15 years before the mid-1990s surge in opioid prescribing, suggesting that overdose death rates may continue along this ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.