April 16, 2019 / 4:17 PM / 3 months ago

U.S. FDA orders withdrawal of transvaginal surgical mesh from market

April 16 (Reuters) - The U.S. Food and Drug Administration on Tuesday ordered makers of transvaginal surgical mesh implants to stop sale and distribution of the product in the United States immediately.

The FDA said makers of the product such as Boston Scientific Corp and Coloplast A/S did not demonstrate a reasonable assurance of safety and effectiveness of these devices.

The companies will have 10 days to submit their plan to withdraw these products from the market, the agency said in a statement here

Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Shinjini Ganguli

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below