The FDA and the Vaginal Mesh Controversy--Further Impetus to Change the 510(k) Pathway for Medical Device Approval

JAMA Intern Med. 2016 Feb;176(2):277-8. doi: 10.1001/jamainternmed.2015.7155.

Authors

Vanessa L Jacoby¹, Leslee Subak², L Elaine Waetjen³

Affiliations

¹ Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.
² Departments of Obstetrics, Gynecology, and Reproductive Sciences; Urology; and Epidemiology & Biostatistics, University of California, San Francisco.
³ Department of Obstetrics and Gynecology, University of California, Davis.

PMID: 26720520
DOI: 10.1001/jamainternmed.2015.7155

No abstract available

Publication types

Research Support, Non-U.S. Gov't
Comment

MeSH terms

Female
Gynecologic Surgical Procedures / instrumentation*
Humans
Pelvic Organ Prolapse / surgery*
Surgical Mesh / statistics & numerical data*

Grants and funding

K24 DK080775/DK/NIDDK NIH HHS/United States