Quantcast

FDA puts restrictions on birth control implant but no recall - KOAM TV 7

FDA puts restrictions on birth control implant but no recall

Updated:

BC-US--Birth Control Implant-Safety,1st Ld-Writethru
FDA puts restrictions on birth control implant but no recall
Eds: Adds background and detail. With AP Photos.
By MATTHEW PERRONE
AP Health Writer

WASHINGTON (AP) - U.S. health officials on Monday placed new restrictions on a permanent contraceptive implant that has been subject to reports of painful complications from thousands of women. But the metal implant, called Essure, will remain on the market.

The Food and Drug Administration said only women who read and sign a brochure about the risks of the device will be able to receive the implant made by Bayer. The checklist of risks must also be signed by the woman's doctor.

The new requirement comes almost two years after the FDA added its strongest warning to Essure, citing problems reported with the nickel-titanium implant. The agency also ordered Bayer to conduct a study of the device's safety.

Patients have reported cases of pain, bleeding, allergic reactions and cases where the implant punctured the uterus or shifted out of place. Those reports are submitted to the FDA by patients, physicians and the manufacturer.

"Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren't receiving this important information," said FDA Commissioner Scott Gottlieb, in a statement. "That is simply unacceptable."

An agency spokeswoman said via email that the new requirements "ensure that the device continues to meet our standards for a reasonable assurance of safety and effectiveness."

In a statement after the announcement, Bayer said it will continue to tell health care providers about "the importance of appropriately counseling each patient on the benefits and risks of Essure."

Public health advocates questioned the FDA's new requirement, suggesting patients may not read the lengthy brochure.

"How many people do you know who would carefully read a 22-page document before signing it?" said Diana Zuckerman, president of the National Center for Health Research, a consumer advocacy group. "In addition to being much too long and technical, the information provided will be confusing to many consumers."

Bayer received FDA approval to sell Essure in 2002 and promoted the product to women as the only non-surgical option for permanent birth control. Essure consists of two nickel-titanium coils inserted into the fallopian tubes, where they spur the growth of scar tissue that blocks sperm from fertilizing a woman's eggs.

Because of the reported complaints, Bayer was ordered to conduct a 2,000-patient study in 2016. Although the company is making "adequate progress," the FDA said Monday that it will require additional study sites to enroll more patients in the study. The agency notes that sales of Essure have fallen 70 percent since the previous FDA restrictions were announced.

Bayer faces lawsuits from approximately 16,000 U.S. women who have received Essure, according to the German conglomerate's latest annual report. While the company is insured against product liability lawsuits, the Bayer notes that the claims "exceed the available insurance coverage." The company stopped selling Essure outside the U.S. last year.

Last month, the FDA reported that it had received 12,000 reports last year about problems with Essure, 90 percent of which involved attempts to remove the device. The agency noted that most of the new reports came from attorneys representing patients suing Bayer.

(Copyright 2018 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.)

4/9/2018 2:22:12 PM (GMT -5:00)

  • Local NewsMore>>

  • KOAM MORNING NEWS TO KNOW 4-19

    KOAM MORNING NEWS TO KNOW 4-19

    Thursday, April 19 2018 8:54 AM EDT2018-04-19 12:54:22 GMT
    COUNCILMAN RESIGNS A newly elected Joplin City Council member steps down, due to prior drug convictions.  Joshua Bard was charged in 2005 in Newton County for "manufacturing a controlled substance".  Joplin's Mayor Gary Shaw tells us Bard's replacement will be selected by the council.  He says he hopes to start the process very soon. ARSON ARREST State investigators say the fire that destroyed a vacant house on Gum Lane in rural Cherokee County on Tues...More >>
    COUNCILMAN RESIGNS A newly elected Joplin City Council member steps down, due to prior drug convictions.  Joshua Bard was charged in 2005 in Newton County for "manufacturing a controlled substance".  Joplin's Mayor Gary Shaw tells us Bard's replacement will be selected by the council.  He says he hopes to start the process very soon. ARSON ARREST State investigators say the fire that destroyed a vacant house on Gum Lane in rural Cherokee County on Tues...More >>
  • Joplin City Council Member Steps Down After Revelations of Drug Convictions

    Joplin City Council Member Steps Down After Revelations of Drug Convictions

    Wednesday, April 18 2018 8:39 PM EDT2018-04-19 00:39:58 GMT

    Newly elected Joplin City Council member Joshua Bard has resigned from council. Bard confirmed to KOAM that his resignation is connected to a drug conviction from 2005.  Mayor Gary Shaw tells us the council will begin accepting applications for a new council member, and that member will be selected by the council. He hopes to address the now vacant seat as early as the next meeting.   

    More >>

    Newly elected Joplin City Council member Joshua Bard has resigned from council. Bard confirmed to KOAM that his resignation is connected to a drug conviction from 2005.  Mayor Gary Shaw tells us the council will begin accepting applications for a new council member, and that member will be selected by the council. He hopes to address the now vacant seat as early as the next meeting.   

    More >>
  • High Ranking Republican in Missouri Senate Joins List of People Calling for Governor Greitens to Resign or Be Impeached

    High Ranking Republican in Missouri Senate Joins List of People Calling for Governor Greitens to Resign or Be Impeached

    Wednesday, April 18 2018 7:29 PM EDT2018-04-18 23:29:01 GMT

    "...you guys are experiencing something that has never happened before in the State of Missouri."

    More >>

    "...you guys are experiencing something that has never happened before in the State of Missouri."

    More >>
Powered by Frankly

KOAM - Licensed to Pittsburg, Kansas
Send tips, ideas and press releases to: tips@koamtv.com
Send newsroom questions or comments to: comments@koamtv.com
Phone: (417) 624-0233 or (620) 231-0400
Web comments or questions: webmaster@koamtv.com
Newsroom Fax: (417) 624-3158

Powered by WorldNow All content © Copyright 2000 - 2018 KOAM. All Rights Reserved. For more information on this site, please read our Privacy Policy, and Terms of Service, and Ad Choices.