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ProPublia: Four Medical Devices that Bypassed FDA Scrutiny

By Mesh Medical Device Newsdesk |

May 10, 2012 ~ ProPublica, an independent journalism organization, reports on four medical devices that are among the thousands pushed into the marketplace every year that do not undergo Food and Drug Administration (FDA) scrutiny. The bottom line – medical devices are big business bringing over $100 billion-a-year to the industry, giving industry the [continue reading…]

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Suffering in Silence: Howard Sadwin’s Story of Metal-on-Metal Hip Failure

By Mesh Medical Device Newsdesk |

Howard Sadwin is 65 years old and lives in Sarasota, Florida. Life has not been the same since a metal-on-metal hip implant in 2007. In fact, during his 10-month hospital stay, Howard’s doctor leaned over and whispered to him that Howard was dying. But Sadwin survived and today is fighting mad about the artificial [continue reading…]

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New England Journal of Medicine – Medical Devices – Balancing Regulation and Innovation

By Mesh Medical Device Newsdesk |

January 19, 2012 ~ In a letter to the Editor of the New England Journal of Medicine (NEJM), (here) January 19, 2012, Neil Feder, M.D. of the Project on Government Oversight writes about the 510(k) process that allows untested medical devices onto the market without premarket approval.

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