FDA Archived Material on Pelvic Mesh

Mesh Medical Device News Desk, October 10, 2017 ~ The U.S. Food and Drug Administration has been looking at the issue of pelvic or transvaginal mesh for more than ten years now.

Though slow to act to recall mesh, to follow up on ordered studies, to create a medical device registry, there have been some decisions, such as reclassifying mesh for pelvic organ prolapse to Class III.

It is worth reminding ourselves what's going on with this so-called watchdog agency.

**Note many of the long-standing FDA releases on mesh including Public Safety Notification have been moved or cannot be found in the archive. MND is trying to track them down.

Archive-It is a data archive business. Here is a list of the articles mined from within the FDA by Archive-It.

FDA Related Information from FDA Website

This link is no longer active:

• Federal Register Notice: Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh

This is the January 2016 order that reclassifies POP (pelvic organ prolapse) mesh to Class III. Tremendously important in that manufacturers now have to prove the safety and efficacy of their product BEFORE it is sold via clinical trials.

• FDA Press Release: FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks

This link is no longer active:

• Final Order for Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair

This link is no longer active:

• Final Order for Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair

This is the July 13, 2011 order that finally says mesh complications are “not rare” and a complete turnaround from the 2008 safety communication that said they were rare! See under Purpose:

• UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse: FDA Safety Communication [ARCHIVED]

White Paper July 2011 on What the FDA knows to date on urogynecologic surgical mesh. 15 pages. Its link to 2008 says it has been moved.

• Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse (July 2011)(PDF - 243KB)
  

News release on July 13, 2011 announcement that POP mesh poses risks.

• Press Release: Surgical placement of mesh to repair pelvic organ prolapse poses risks [ARCHIVED]

Not found:

• Federal Register Notice: Urogynecologic Surgical Mesh

Not found:

• Federal Register Notice Ammendment: Urogynecologic Surgical Mesh

Some of you may have been in attendance of the September 8-9, 2011 expert panel on pelvic mesh. Some of you may have testified. The transcript is here but the testimony from many injured patients is not. Janet Holt- Page 86. Sherri Palm Page 89. Note* The FDA said it would be monitoring pelvic mesh used for SUI. It has not done so to date!

• 2011 Meeting Materials of the Obstetrics and Gynecology Devices Panel [ARCHIVED]

FDA Public Health Notification, October 20, 2008, updated July 13, 2011, This is the one that says the complications from POP and SUI mesh are “rare.” This after the FDA received over 1,000 reports from nine surgical mesh makers of complications that were associated with surgical mesh devices used on women and placed transvaginally.

• https://wayback.archive-it.org/7993/20161022130905/http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm