All entries by this author

Doctor Disconnect?

Apr 9th, 2013 | By
Doctor Disconnect?

April 9, 2013 ~  Doctors say their credo is to put patients first.  Why then do so many women talk about the conversations they have with their doctors after they start to feel their implanted mesh is causing complications and not providing a cure?   Across the board doctors say something like this:         “It’s not
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Dr. Robert Bendavid: Women May Not Always be Candidates for Surgical Mesh for Hernias

Apr 9th, 2013 | By
Dr. Robert Bendavid: Women May Not Always be Candidates for Surgical Mesh for Hernias

April 9, 2013 ~ Dr. Robert Bendavid  is a well-known hernia surgeon who in this editorial for the Africa Middle East  Hernia Society discusses surgical mesh. Past president and a founding father of the American Hernia Society, Dr. Bendavid has performed thousands of procedures and is presently associated with the Shouldice Hospital in Toronto where the natural tissue, mesh-free,
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FDA Workshop on Health of Women

Apr 9th, 2013 | By

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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Q&A: Dr. Anthony Visco, AUGS President

Mar 31st, 2013 | By
Q&A: Dr. Anthony Visco, AUGS President

April 3, 2013 ~ Dr. Anthony Visco is Chief of Urogynecology at Duke Univ. Medical Center and President of AUGS.  The American Urogynecologic Society (AUGS) was founded in 1979 and is a professional organization of 1,400 physicians and allied health professionals who care for women with pelvic floor disorders, specifically pelvic organ prolapse (POP) and
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Highlights from AUGS Informed Consent Toolkit

Mar 30th, 2013 | By
Highlights from AUGS Informed Consent Toolkit

  Some Highlights from the AUGS Informed Consent Toolkit, September 8-9, 2011 “At this time, AUGS does not support the routine use of transvaginal mesh for the repair of POP.” “Given the potential risks, AUGS suggest future placement of transvaginal mesh for POP repair should be judicious and be performed only by surgeons with appropriate
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FDA: Stress Urinary Incontinence (SUI) Surgical Mesh Reports up 36 Percent

Mar 29th, 2013 | By
FDA: Stress Urinary Incontinence (SUI) Surgical Mesh Reports up 36 Percent

March 29, 2013 ~ In September 2011, the U.S. Food and Drug Administration convened a panel of experts to try and get a handle on the concerning number of complications the agency was receiving about surgical mesh used to treat pelvic organ prolapse (POP)  and stress urinary incontinence (SUI).  The experts  suggested that because of the
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Urogyn Society Opposes Restrictions on Surgical Uses of Mesh

Mar 26th, 2013 | By
Urogyn Society Opposes Restrictions on Surgical Uses of Mesh

March 26, 2013~  Today, the American Urogynecologic Society (AUGS) issued a position statement strongly opposing restrictions that ban surgical options for the treatment of pelvic organ prolapse (POP), including transvaginal surgical mesh cleared for use by the U.S. Food and Drug Administration (FDA). The AUGS position states that it is essential for patients and their
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Surgical Mesh Complications Tear Lives Apart

Mar 25th, 2013 | By
Surgical Mesh Complications Tear Lives Apart

March 25, 2013~ First Coast News Jacksonville has just aired the latest mesh complication story at its Gannett station. See the story here. “The pain was severe enough that I couldn’t stay still on the bed.”  “It just became unbearable.  I went into seclusion from this.“ These are some of the comments from the four
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PBS “Need to Know” Friday, March 22 on FDA and Medical, Surgical Devices

Mar 22nd, 2013 | By
PBS “Need to Know”  Friday, March 22 on FDA and Medical, Surgical Devices

March 22, 2013 ~ Friday night, March 22, Public Broadcasting (PBS) looks into the U.S. Food and Drug Administration (FDA) oversight of medical devices and how so many enter the market with little review and oversight. The 510(k) process allows devices on the market after the manufacturer requests clearance from the FDA and names a
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Gross v. Johnson & Johnson – The Post-Trial Process

Mar 22nd, 2013 | By
Gross v. Johnson & Johnson – The Post-Trial Process

March 22, 2013 ~ by ADAM SLATER   Mr. Slater of Mazie, Slater Katz & Freeman LLC of Roseland, New Jersey recently represented plaintiff Linda Gross in her product liability lawsuit against Johnson & Johnson over its Prolift surgical mesh used to treat prolapse.  She was awarded  $3.35 in compensatory damages and $7.76 million in
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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.