FDA Warning Notice and News

12th January 2012

Food and Drugs Administration (FDA) Public Notice
UPDATE 4th January 2012
Based on assessment of Medical Device Reports (adverse event reports) submitted to the FDA, evaluation of the published literature, and the September 2011 Obstetrics-Gynecology Devices Panel meeting, the FDA is considering the recommendation that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) be reclassified from Class II to Class III. The FDA continues to assess the safety and effectiveness of urogynecologic surgical mesh devices, through: Review and analysis of published literature, Medical Device Reports (adverse event reports) submitted to the agency, and post-approval study
Comment: Where is the study for Hernia Mesh???????
To read the whole article Copy and Paste this link into your browser: www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ ImplantsandProsthetics/UroGynSurgicalMesh/default.htm
Or Click on the external link below to open the FDA webpage www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm >>>
OR READ The Food and Drugs Administration (FDA) Public Notice TEXT as showing on their website as below:-
Urogynecologic Surgical Mesh Implants
Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material.

Surgical mesh can be used for urogynecologic procedures, including repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is permanently implanted to reinforce the weakened vaginal wall for POP repair or support the urethra or bladder neck for the repair of SUI.

Based on an updated analysis of adverse events reported to the FDA and complications described in recent scientific literature, on July 13, 2011 an FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse1 was issued to inform the medical community and patients that:

serious complications associated with surgical mesh for transvaginal repair of POP are not rare it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair The FDA continues to evaluate the effects of using surgical mesh for treatment of urine leakage during moments of physical activity (stress urinary incontinence) and will provide updates on this webpage at a later date.

On this webpage, the FDA provides information about the use of surgical mesh placed transvaginally for the treatment of POP, recommendations for health care providers and women to help reduce risks, and steps to report problems to the FDA. The information provided on this webpage is not meant to replace a discussion with your health care provider.

As a USA Date 01/04/2012 and as UK Date 4th January 2012:

• Based on assessment of Medical Device Reports (adverse event reports) submitted to the FDA, evaluation of the published literature, and the September 2011 Obstetrics-Gynecology Devices Panel meeting, the FDA is considering the recommendation that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) be reclassified from Class II to Class III.


• Review and analysis of published literature, Medical Device Reports (adverse event reports) submitted to the agency, and post-approval study reports.


• Epidemiological research on safety and effectiveness of surgical mesh, as a part of our effort to better understand possible adverse events associated with surgical mesh for SUI and POP.


• Collaborations with professional societies and other stakeholders to fully understand the postmarket performance of urogynecologic surgical mesh devices, as well as the occurrence of and signs and symptoms associated with specific adverse events.


• Collecting and reviewing all available information about currently marketed urogynecologic surgical mesh devices


• Mandating postmarket surveillance studies (“522 studies”) by manufacturers of urogynecologic surgical mesh devices. On January 03, 2012, the FDA issued:


• 88 postmarket study orders to 33 manufacturers of urogynecologic surgical mesh for POP; and


• 11 postmarket study orders to seven manufacturers of single-incision mini-slings for SUI.

The manufacturers will be required to submit study plans to the FDA that address specific safety and effectiveness concerns related to surgical mesh devices for POP and single-incision mini-sling devices for SUI. Data from the studies will enable the agency to better understand the safety and effectiveness profiles of these devices. For information on the status of the 522 Postmarket Surveillance Studies and the FDA’s authority to order 522 studies, visit the 522 website2.

The FDA will provide additional information to the public as it becomes available.

Source: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ ImplantsandProsthetics/UroGynSurgicalMesh/default.htm

12th January 2012
FDA Orders Safety Studies for Vaginal Implants Made By J&J and C.R. Bard
Johnson & Johnson (JNJ) and C.R. Bard Inc. (BCR) must study rates of organ damage and complications linked to vaginal mesh implants, U.S. regulators said, responding to patient advocates who say the devices have harmed women. To read more showing on our website please click on this link:- www.tvt-messed-up-mesh.org.uk/truth-in-medicine.html >>>

2nd Septemeber 2011
SURGICAL MESH FOR TREATMENT OF WOMEN WITH
PELVIC ORGAN PROLAPSE
AND
STRESS URINARY INCONTINENCE
FDA EXECUTIVE SUMMARY
OBSTETRICS & GYNECOLOGY DEVICES
ADVISORY COMMITTEE MEETING
SEPTEMBER 8-9, 2011
www.tvt-messed-up-mesh.org.uk/fda-meeting-8-9th-sept-2011.pdf >>>

Public Citizen Group USA Urges FDA to Recall Surgical Mesh
Product exposes female patients to "serious risks," says Public Citizen.
Published: August 25, 2011
Non-absorbable synthetic surgical meshes used to repair pelvic organ prolapse (POP) offer no significant benefits and expose female patients to serious complications and harm, claims the consumer advocacy group Public Citizen. Please click the following link to read more:
www.outpatientsurgery.net/news/2011/08/19-Group-Urges-FDA-to-Recall-Surgical-Mesh >>>

Public Citizen Group USA Petition to Ban Surgical Mesh for Transvaginal Repair of Pelivic Organ Prolapse
www.citizen.org/documents/Petition_to_Ban_Surgical_Mesh.pdf >>>

SECOND PUBLIC HEALTH NOTICE SENT OUT
Date Issued: July 13, 2011
FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm >>>

FDA: pelvic mesh for women riskier than thought
WASHINGTON (AP) — A product commonly used in surgery to treat incontinence and other women's health problems causes far more complications than previously thought and is likely exposing patients to unnecessary risks, according to U.S. health officials. news.yahoo.com/fda-pelvic-mesh-women-riskier-thought-160240194.html >>>

Truth in Medicine
Truth in Medicine and its' Success Stories
Our most important success is when we, as patients advocates, prevent someone's life from being destroyed by the implantation of Synthetic Surgical Mesh. A huge step in that direction happened when the FDA issued the following Public Health Notification in October 2008.

FIRST PUBLIC HEALTH NOTICE ISSUED BY THE U.S. FOOD AND DRUG ADMINISTRATION
October 21, 2008 Public Health Notification:
Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence:
www.truthinmedicine.us.com/successatthefda.html.

If it wasn't for Lana Keeton founder of Truth in Medicine and her team in the USA this notice would not of gone out! Well done my precious friend.

FIRST PUBLIC HEALTH NOTICE ISSUED BY THE U.S. FOOD AND DRUG ADMINISTRATION
Issued: October 20, 2008
U.S. FOOD AND DRUG ADMINISTRATION Archived Safety Alerts, Public Health Advisories and Notices - FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence direct link to view:
www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm

FDA report Serious Complications with Surgical Mesh for Gynecologic Surgery
(Figures have substantially increased since this video was produced)

The USA and Canada have released this Public Health Notice, Why hasn't the UK?

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