About Careers Internship MedBlog Contact us
Medindia LOGIN REGISTER

USFDA Issues New Rules for Using Transvaginal Devices to Repair Pelvic Organ Prolapse

by Reshma Anand on January 5, 2016 at 2:03 PM
Font : A-A+

USFDA Issues New Rules for Using Transvaginal Devices to Repair Pelvic Organ Prolapse

Doctors have been commonly using surgical mesh to repair Pelvic Organ Prolapse (POP) transvaginally for many years. Now the U.S. Food and Drug Administration has announced two new rules for manufactures to strengthen the data requirements of surgical mesh.

Women with POP are implanted with a surgical mesh using a minimally invasive transvaginal technique. But, recently FDA has received thousands of reports of surgical mesh complications like severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues.



Therefore, an advisory panel of experts recommended in 2011 that more data is needed to establish the safety of the device. Now, the FDA has issued two rules for manufactures namely,
  • Reclassify these medical devices from class II (moderate-risk devices) to Class III (high-risk devices).
  • Submit a premarket approval (PMA) application.
"These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse. We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures," said William Maisel, deputy director of science and chief scientist for the FDA's Center for Devices and Radiological Health.

Source: Medindia

News A-Z
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
What's New on Medindia
H1N1 Influenza Prevention in Children: What Parents Need to Know
Dietary Factors Responsible for Dihydrotestosterone (DHT) Production and Hair Loss
Test Your Knowledge About Chromosomes?
View all
Recommended Reading
News Archive
Date
Category
News Category

Medindia Newsletters Subscribe to our Free Newsletters!
Terms & Conditions and Privacy Policy.

More News on:
Tongue Abnormalities Prolapse of Uterus Pelvic Floor Disorders Pelvic Organ Prolapse 

Most Popular on Medindia

Find a Doctor Blood - Sugar Chart Sanatogen Calculate Ideal Weight for Infants Blood Pressure Calculator Blood Donation - Recipients The Essence of Yoga A-Z Drug Brands in India Diaphragmatic Hernia Nutam (400mg) (Piracetam)
This site uses cookies to deliver our services. By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use

Sexual Problem

Consult an Expert

×

USFDA Issues New Rules for Using Transvaginal Devices to Repair Pelvic Organ Prolapse Personalised Printable Document (PDF)

Please complete this form and we'll send you a personalised information that is requested

You may use this for your own reference or forward it to your friends.

Please use the information prudently. If you are not a medical doctor please remember to consult your healthcare provider as this information is not a substitute for professional advice.

Name *

Email Address *

Country *

Areas of Interests