FDA May Vaginal Mesh Meeting, Vaginal Mesh Helpline Reports

Vaginal Mesh Helpline offers support, information, reviewed vaginal mesh lawyers and urogynecologists for women injured by vaginal mesh implants. The the inaugural U.S. Food and Drug Administration (“FDA”) Patient Network Annual Meeting,  took place on May 18, 2012. The meeting featured presentations from FDA experts and open discussions with patients and advocacy groups regarding the FDA drug and medical device approval processes. Speakers from numerous FDA departments outlined FDA processes and goals, and solicited audience input with questions and answers at the end of each presentation.* One attendee asked about how the FDA determines classification levels for medical devices and how the FDA tests the devices to see if they are safe. The FDA has recently come under fire given the widespread controversy over its expedited 510(k) approval process, which granted market approval for both transvaginal mesh implants and all metal hip implants.

FDA Wants To Better Monitor Patient Feedback on the Vaginal mesh Implants.

The Vaginal Mesh Helpline is hopeful that  the FDA will act on the results of the discussion on its drug and device approval policies and solicitation of  patient input for these important issues, especially in light of the recent DePuy hip recall and FDA warnings concerning vaginal mesh implants. The vaginal mesh helpline has spoken to hundreds of  women  with injuries stemming from  the vaginal mesh and the stories we hear are horrific. We encourage women to make adverse incident reports with the FDA regarding their complications from the prolene mesh.

Meeting Overview Focus Vaginal Mesh and DePuy Hip Replacement

U.S. Food and Drug Administration Inaugural Patient Network Annual Meeting, hosted by FDA’s Office of Special Health Issues (OSHI) in collaboration with the Center for Drug Evaluation and Research (CDER), the Center for Biologics Research and Evaluation (CBER), and the Center for Devices and Radiological Health (CDRH).

This meeting was held to allow FDA to gain a greater understanding of how patients define and perceive benefits and risks related to medical products. The FDA Patient Network hosted this one-day meeting to:

  •     review the drug and medical device regulatory processes;
  •     discuss where patient input is practical and most valuable; and,
  •     explore practical approaches to collecting meaningful patient input.

The meeting included a series of presentations, exercises, and panel discussions to facilitate a conversation with the patient community about these important topics. FDA asked patients and other interested parties to consider specific questions, posed in a 4/19/2012 Federal Register Notice, designed to frame discussion at the meeting.

Working with Patients to Explore Benefit/Risk: Opportunities & Challenges

Video Recording of the May 18, 2012 event:

Part 1

Keynote Address Stephen Spielberg, M.D., Ph.D., Deputy Commissioner for Medical Products and Tobacco
Drug Development: Laws, Regulations, Statutory & Regulatory Limitations Janet Woodcock, M.D., Director, CDER

Part 2

Drugs and Biologics Development 101 Robert Yetter, Ph.D., Associate Director for Review Management, CBER
Devices 101 Peper Long, Associate Director, External Relations, CDRH
Drugs, Biologics and Devices Question and Answer
Richard Klein, Director, Patient Liaison Program, OSHI (moderator)

Part 3

Benefit-Risk Framework Patrick Frey, Director, Office of Planning and Analysis, CDER
Patient-Focused Drug Development Theresa Mullin, Ph.D., Director, Office of Planning and Informatics, CDER
Making Benefit-Risk Determinations Peper Long, Associate Director, External Relations, CDRH
Patient Risk Tolerance Survey for Obesity Devices Martin Ho, M.S., Division of Biostatistics, Office of Surveillance and Biometrics, CDRH

Part 4

Patient Risk Tolerance Survey for Obesity Devices Martin Ho, M.S., Division of Biostatistics, Office of Surveillance and Biometrics, CDRH (continued)
Discussion of Federal Register Notice Questions
Patient Perspectives Panel & Audience Discussion James Valentine, M.H.S., Project Manager, FDA Patient Network, OSHI (moderator)
FDA Reaction Panel James Valentine, M.H.S., Project Manager, FDA Patient Network, OSHI (moderator)
Closing Remarks Richard Klein, Director, Patient Liaison Program, OSHI

The vaginal mesh helpline is hoping that something will come of these meetings and some action will be taken to protect women from this pandemic that has befallen them called the vaginal mesh. Women are suffering while meetisng take place. Lives are being ruined, jobs are being lost do to medical disability form the mesh and homes are going into foreclosure. The mesh has broke up marriages and left women confused, feeling alone and in despair about their lives after the vaginal mesh.Doctors have been insensitve about their mesh pain and they are having trouble getting honest treatment. We hear horrific stories on a daily basis and hope the talking will stop and action will begin. If you are having complications they are real and you are not alone. Call the vaginal mesh helpline today.