Posts Tagged ‘ infection ’

Hope for the New Year

Dec 27th, 2012 | By
Hope for the New Year

December 27, 2012 ~ Our Patient Advocate Linda K.  – always at the keyboard even during the busy holiday season- wishes you all the best this time of year. She warns mesh doctors and sales reps are not going away and neither are your mesh symptoms of pain, erosion,  nerve damage, painful sex, infection, limited
[continue reading...]



Hernia Mesh Complications – Is the FDA Watching? Part I

Nov 28th, 2012 | By
Hernia Mesh Complications – Is the FDA Watching? Part I

November 28, 2012 ~ The U.S. Food and Drug Administration (FDA) has been updating pages on mesh used for hernia repair. Unlike transvaginal mesh, also made of plastic polypropylene, there is no Health Notification or Safety Warning on hernia mesh. That means there are no active lawsuits involving hernia mesh, but injuries are coming into
[continue reading...]



Doctor: Plaintiff Lawyers in ‘Attack Mode’ Over Mesh Complications

Sep 25th, 2012 | By
Doctor: Plaintiff Lawyers in ‘Attack Mode’ Over Mesh Complications

Sept 25, 2012 ~ A recent news release from an ObGyn in Minneapolis shows that at least he is on the offensive when it comes to mesh injuries. The doctor doesn’t let the facts get in the way. For some reason the doctor, an Ob/Gyn at Oakdale Obstetrics & Gynecology in the Minneapolis, Minnesota area
[continue reading...]



What Happened to the FDA Request for Transvaginal Mesh Studies?

Sep 19th, 2012 | By
What Happened to the FDA Request for Transvaginal Mesh Studies?

September 19, 2012 ~ Last January, after a five-fold increase in complications was noted by the U.S. Food and Drug Administration (FDA) concerning synthetic mesh used in women to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), the FDA ordered mesh makers to find out why. At the time, the unprecedented request was
[continue reading...]



Dollars and Sense? Saving Money on Hernia Mesh

Sep 17th, 2012 | By
Dollars and Sense? Saving Money on Hernia Mesh

  “Application of Evidence-Based Value Analysis: Standardization of Surgical Mesh Products” In this White Paper, Winifred Hayes, a medical efficiency analyst, known as, “Your Outsourced Research Partner,” tells hospitals how to save money buying hernia mesh by being more efficient. Problem: In the case of hernia mesh, hospitals buy mesh from a limited number of
[continue reading...]



Dr. Wei Talks (continue) Part 2

Jul 12th, 2012 | By
Dr. Wei Talks (continue) Part 2

On July 13, 2011 the FDA issued a Safety Communication (here) which says:  FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This
[continue reading...]



Hernia from Hell Treated with Biologic Mesh

Feb 7th, 2012 | By
Hernia from Hell Treated with Biologic Mesh

February 6, 2012 ~ James Fico had a problem. The Sarasota Herald-Tribune (here) reports on the North Port man’s basketball-size hernia that protruded from his belly for more than five years. (Caution- the photos in this article are not for the weak of heart). Unfortunately for Fico, 62, he had had a major heart attack
[continue reading...]



Upcoming Miami Hearing on Transvaginal Mesh Litigation and Consolidation

Jan 12th, 2012 | By
Upcoming Miami Hearing on Transvaginal Mesh Litigation and Consolidation

JANUARY 12, 2012 ~ A growing number of women from around the country who are plaintiffs in transvaginal mesh litigation have a court date of Wednesday, January 26 in Miami. The Judicial Panel on Multidistrict Litigation (MDL)  is set to hear requests by plaintiff attorneys to have thousands of defective mesh lawsuits consolidated in the
[continue reading...]



FDA Orders Manufacturers to Study Mesh Complications

Jan 5th, 2012 | By
FDA Orders Manufacturers to Study Mesh Complications

JANUARY 4, 2012 ~ Bloomberg reports that the Food and Drug Administration’s division that oversees medical devices has ordered surgical mesh manufacturers to study how often synthetic mesh harms women by causing infection and organ damage. (story is here) The order follows an FDA report last summer of a five-fold jump in the number of
[continue reading...]



Linda Dodson: Suffering in Silence no Longer after Mesh and Medical Mishaps

Dec 1st, 2011 | By
Linda Dodson: Suffering in Silence no Longer after Mesh and Medical Mishaps

Linda Dodson, a dark-haired, attractive Georgia peach with a long southern drawl to match decided to visit a new gynecologist near her home in Georgia, just south east of Atlanta. After about 30 minutes on the exercise bicycle she would experience a muscle spasm in the urethra area. Not a big deal, she thought. Share
[continue reading...]



We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.