FDA orders medical device companies to stop selling pelvic mesh

  • 📰 thejournal_ie
  • ⏱ Reading Time:
  • 31 sec. here
  • 2 min. at publisher
  • 📊 Quality Score:
  • News: 16%
  • Publisher: 50%

Indonesia Berita Berita

Indonesia Berita Terbaru,Indonesia Berita utama

The FDA said it couldn’t assure women that these devices were safe and effective longterm.

The CMO in Ireland said there is an evidence base to support the use of some mesh devices. Image: Michelle Hennessy/TheJournal.ie The CMO in Ireland said there is an evidence base to support the use of some mesh devices. Image: Michelle Hennessy/TheJournal.ie THE US FOOD and Drug Administration has ordered medical device companies to stop all sales and distribution of surgical mesh used in surgeries to repair pelvic organ prolapse.

A report from the Chief Medical Officer in Ireland last year found devices known as transvaginal mesh implants , used for the treatment of pelvic organ prolapse, are no longer regarded as appropriate as the first line treatment. As part of a 2016 reclassification of the devices as high risk, manufacturers were required to submit and obtain approval of premarket approval applications, the agency’s most stringent device review pathway, in order to continue marketing their devices in the US.

However the use of other vaginal mesh devices is likely to recommence – including for treatment of prolapse.

Berita ini telah kami rangkum agar Anda dapat membacanya dengan cepat. Jika Anda tertarik dengan beritanya, Anda dapat membaca teks lengkapnya di sini. Baca lebih lajut:

 /  🏆 32. in İD
 

Terima kasih atas komentar Anda. Komentar Anda akan dipublikasikan setelah ditinjau.

Indonesia Berita Terbaru, Indonesia Berita utama

Similar News:Anda juga dapat membaca berita serupa dengan ini yang kami kumpulkan dari sumber berita lain.

Sibling dispute over Kerry drilling company leads to €245,000 court orderDispute between brothers arises from failure to honour settlement last year Why the furniture ad ?
Sumber: IrishTimes - 🏆 3. / 98 Baca lebih lajut »