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Tag Archives: FDA

Essure birth control device removed

Essure Birth Control Gets FDA’s Strongest Warning

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, November 15, 2016 ~ The U.S. Food and Drug Administration has approved a label change on Essure Birth Control that includes the strongest warning a device can carry.  Known as a Black Box warning, the label change will now clearly warn about the significant side effects associated with Essure, including [continue reading…]

FDA Office of the Commissioner, Silver Spring, MD

FDA Covers for Device Makers, Keeps Injuries Under Wraps

By Mesh Medical Device Newsdesk |

Medical Device News Desk, October 20, 2016 ~ The system is supposed to be transparent.   Medical device makers are required to alert the U.S. Food and Drug Administration (FDA) when their products injure consumers or malfunction.  The FDA then theoretically alerts doctors who alert consumers. In rare cases, such as pelvic mesh, the FDA will [continue reading…]

Consumers Union Safe  Patient Project

FDA Funding: Medical Device Makers and Lap Dog Watchdogs

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, August 29, 2016 ~ The medical device industry and the U.S. Food and Drug Administration (FDA) have reached tentative agreement on $1 billion in funding from the very industry it regulates. The Medical Device User Fee Agreement IV (MDUFA IV) will be delivered to Congress in January. It represents [continue reading…]

Rectocele, a form of POP, Image from FDA

What Exactly is Pelvic Organ Prolapse?

By Mesh Medical Device Newsdesk |

Mesh News Desk, August 17, 2016 ~ You’ve heard the term “pelvic organ prolapse” and may have seen the shortcut POP.  But what does it mean and how likely are to be be affected by this condition? What is Pelvic Organ Prolapse? Many women are unaware of the medical condition known as pelvic organ [continue reading…]

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…]

atrium building

Atrium Medical C-Qur Hernia Mesh Lawsuits Moving Forward

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, July 10, 2016 ~ This article is Sponsored Content written by Brett Vaughn, RN, BSN, and JD of the Hollis Law firm, of Overland Park, Kansas, about Atrium Medical Hernia Mesh and specifically its C-Qur hernia mesh.   As many of you readers know, unlike transvaginal mesh, there are few [continue reading…]

Alliance for natural health death meter

Report: Deaths Caused by the FDA

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, July 5, 2016 ~ Deaths Caused by the FDA That is the title of a campaign by the Alliance for Natural Health, USA.  Digging into the Food and Drug Administrations (FDA) database, the consumer group, that promotes sustainable natural health, counts 750,659 deaths caused by FDA-approved drugs, vaccines and [continue reading…]

Woman statue resized

Teresa Stevens Speaks Out About How She Got Involved in Boston Scientific Lawsuit Over Counterfeit Transvaginal Mesh

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, June 6, 2016 ~  On October 27, 2014, Teresa Stevens was preparing for a scheduled hysterectomy when, at the suggestion of her doctor, she agreed to have a Boston Scientific Obtryx Halo vaginal mesh implanted into her body, like thousands of American women do each year. The problems started [continue reading…]

FDA logo green background 240

Where is the FDA on Pelvic Mesh Today?

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, June 7, 2016 ~ The FDA has been slow to act and react to mesh complications.   Be sure to make your report to the agency so it has the ammunition it needs to act.   The first warning came from the U.S. Food and Drug Administration (FDA) in [continue reading…]

Power morcellator, Contemporary ObGyn

Study: Insufficient Science to FDA Allows Med Devices On the Market

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, May 22, 2016 ~  The U.S. Food and Drug Administration (FDA) has put safety in the back seat in approving several high risk devices for obstetric and gynecological procedures, according to a study by researchers at Northwestern University. Citing the problems with transvaginal mesh, power morcellators, and the Essure [continue reading…]

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