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Tag Archives: MAUDE Database

wen soap

FDA Says it’s Taken 21,000 reports of Wen Hair Care Complaints

By Mesh Medical Device Newsdesk |

Mesh News Desk, July 20, 2016 ~ The U.S. Food and Drug Administration says it has received 127 adverse event reports about the WEN Hair products. Promoted on television by celebrity stylist, Chaz Dean, the FDA says his office has received 21,000 complaints. Complaints include reports of balding, rashes and hair breakage. See the [continue reading…]

Pacemaker, Courtesy WikiCommons, Steven Fruitsmaak

How to Post an Adverse Event with the FDA

By Mesh Medical Device Newsdesk |

MND, August 30, 2015 ~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 [continue reading…]

Anonymous woman, WikiCommons

Your Turn: After the Ethicon decision

By Mesh Medical Device Newsdesk |

This woman who will go unnamed has written her thoughts about the Charleston decision regarding the TVT implant and the judge’s decision to cut short a jury decision and to make the decision on his own.   She admits she was frustrated and it was 3 am but she felt better afterward.  As the only [continue reading…]

Prolene mesh

Find Your Mesh in the 510(k) Process

By Mesh Medical Device Newsdesk |

For those readers who want to know more about the mesh they may have had implanted for pelvic organ prolapse, stress urinary incontinence or hernia, the process is made easier if you have the Medical Device approval number from the FDA. Below is a handy list of 510(k) approvals which you must look up [continue reading…]

FDA medwatch form 200

FDA Asks Consumers to Report Product Failures

By Mesh Medical Device Newsdesk |

June 10, 2013 ~ New and Improved? The U.S. Food and Drug Administration (FDA) is celebrating 20 years of the MedWatch program by providing consumers with a new form that should encourage consumers and medical professionals to report adverse events, complications and bad outcomes with drugs and medical devices, cosmetics, medical equipment, food or [continue reading…]

D20proliftm graphic  he wrote it

FDA Workshop on Health of Women

By Mesh Medical Device Newsdesk |

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 [continue reading…]

Dr. Peggy Pence, Courtesy CVN

Day 8: Linda Gross v Ethicon, Prolift Launched Under FDA Radar

By Mesh Medical Device Newsdesk |

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 [continue reading…]

Dr. Kevin Petersen, YouTube, No Insurance Surgery

Hernia Mesh Complications- Is the FDA Watching? Part II

By Mesh Medical Device Newsdesk |

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 [continue reading…]

Money graphic, WikiCommons

Dollars and Sense? Saving Money on Hernia Mesh

By Mesh Medical Device Newsdesk |

  “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 [continue reading…]

Consumers Union on Improving the Safety of Medical Devices

By Mesh Medical Device Newsdesk |

  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 [continue reading…]

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