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30 Months is Up! POP Mesh is Officially High Risk, Too Late for Many

Prolift for POP repair Mesh Medical Device News Desk, July 10, 2018 ~ Pelvic Organ Prolapse (POP) polypropylene mesh, that has injured so many, has just suffered another blow. After an initial announcement and a 30 month waiting period, finally this month, the FDA has officially reclassified POP [...]

By |2018-10-22T17:32:39-04:00July 10th, 2018|FDA News|13 Comments

All Mesh “High Risk” in Australia

Uphold, Taranakiobgyn, NZ website Mesh Medical Device News Desk, October 30, 2017 ~ In a quiet but striking move, Australia's drug and medical device regulator has strengthened the classification of pelvic mesh, increasing the likelihood it will not be used, especially as a first-line treatment. If you were [...]

By |2017-11-02T13:59:36-04:00October 30th, 2017|Featured|26 Comments

FDA Pilot Program Helps Manufacturers Streamline Approval of Medical Devices

Mesh Medical Device News Desk, September 18, 2017 ~ The FDA spends much of its resources working with device and drug manufacturers to help ease their way to market. Here is another example of a newly announced pilot program that will help do just that.  Unlike drugs, high-risk medical devices, [...]

By |2017-09-18T00:24:03-04:00September 18th, 2017|FDA News|5 Comments

FDA Panel Wants More Data on Mesh Tx for Incontinence, MedPage Today, September 9

MedPage Today (here)  reports an FDA advisory panel meeting over synthetic mesh used to treat stress urinary incontinence (SUI) said it would like more scientific data on the newer generation of devices but recommended leaving in place the 510(k) approval process. FDA Panel Listens to Industry, Patients, Staff The Obstetrics [...]

By |2011-09-13T01:50:01-04:00September 13th, 2011|Media Reports|0 Comments