Posts Tagged ‘
MAUDE Database ’
Apr 9th, 2013 |
By Jane Akre
April 9, 2013 ~ According to a new page on the FDA’s website (here), a public workshop will be held on HoW to Improve the Health of Women (HoW). The purpose is to delve into how some medical devices work differently in women than men. It’s been noted that some hip implants have an early
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Posted in FDA |
2 comments
Tags: CDRH, FDA, Food and Drug Administration, MAUDE Database, surgical mesh, women's health
Jan 22nd, 2013 |
By Jane Akre
January 22, 2013 ~ Much thanks to Courtroom View Network for access to the live court proceedings and graphics shown to the jury. The Prolift surgical mesh did not undergo any FDA approval before it was marketed in March 2005. Last June Ethicon, a division of Johnson & Johnson announced it was removing Prolift and
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Posted in Legal News |
1 Comment »
Tags: 510(k), adhesion formation, Bladder, Courtroom View Network, David Mazie, Dr. Peggy Pence, dyspareunia, erosions, Ethicon, extrusion, fistula formation, Gynecare Prolift, Gynecare Prolift Pelvic Floor Repair System, Gynemesh PS, IFU (Instructions for Use), inflammatory reaction, Johnson & Johnson, Linda Gross v Ethicon, MAUDE Database, mesh removal, nerves, potentiation inflammation, predicate device, Prolift M, Prolift pelvic organ repair mesh, Prolift surgical mesh, scarring that results in implant contraction. Punctures or lacerations of vessels, the danger of pudendal neuralgia, urethra or bowel
Nov 28th, 2012 |
By Jane Akre
November 28, 2012 ~ Continuation from Part I, According to hernia mesh removal surgeon, Dr. Kevin Petersen, in a certain percentage of patients, the body will detect hernia mesh as a foreign material and will reject it. Symptoms may include scar tissue that leads to chronic pain and causes mesh to shrink and shrivel up,
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Posted in Medical News |
4 comments
Tags: Bard 3D Max mesh, Dr. Kevin Petersen, Ethicon, foreign material, Hernia Mesh, hernia mesh complications, hernia removal surgeon, Johnson & Johnson, MAUDE Database, MDND, Mesh medical Device News Desk, No Insurance Surgery Center, polypropylene, Proceed, Prolene 3D Patch Mesh, Prolene Hernia System, Topix
Sep 17th, 2012 |
By Jane Akre
“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
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Posted in Feature |
1 Comment »
Tags: Adverse events, biologic mesh, clinical data, hematoma, Hernia Mesh, infection, MAUDE Database, MDND, polyethylene, postoperative pain, PTFE, recurrence, seroma, surgical mesh
Feb 8th, 2012 |
By Jane Akre
Improve the safety of medical devices An overview of Consumers Union’s Safe Patient Project Initiative Medical devices, like eyeglasses and contact lenses, are a part of our everyday lives and are a growing part of the health care we receive. Complex devices like artificial hip joints, surgical mesh, and cardiovascular stents, are permanently implanted
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Posted in Op-Ed |
No Comments »
Tags: 510(k), Consumers Union, dangerous medical devices, implantable devices, MAUDE Database, mesh complications, surgical mesh, transvaginal mesh
Aug 30th, 2011 |
By Jane Akre
When you have a new car that develops a “safety” issue i.e. braking, steering, airbags, wiring, engine cooling, unintended acceleration etc, the auto dealer reports the problems to the manufacturer, who by law, must report the issue to the National Highway Traffic Safety Administration within five days. But when a patient has a problem with
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Posted in FDA |
9 comments
Tags: 510(k) NHTSA, Adverse Event reporting, FDA, MAUDE Database, MedWatch, Public Health Notifications, Suffering in Silence, Suzanne McClain