All entries by this author
Apr 9th, 2013 |
By Jane Akre
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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Posted in Your Turn |
9 comments
Tags: Dr. Clark Likness, Dr. Robert Bendavid, Linda Gross v Ethicon, mesh complications, Urogynecologist
Apr 9th, 2013 |
By Jane Akre
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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Posted in Op-Ed |
6 comments
Tags: American Hernia Society, C.R.Bard, Dr. Robert Bendavid, pelvic organ prolapse, polypropylene, POP, Shouldice hernia Centre, Stress urinary incontinence, SUI, surgical mesh, Toronto
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
Mar 31st, 2013 |
By Jane Akre
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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Posted in Feature |
15 comments
Tags: Adverse events, AE, AUGS President, FDA, informed consent, MAUDE, Mesh medical Device News Desk, pelvic organ prolapse, POP, prolapse repair, Q&A: Dr. Anthony Visco, Stress urinary incontinence, SUI, transabdominal mesh, urogynecology, vaginal mesh, Visco
Mar 30th, 2013 |
By Jane Akre
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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Posted in Feature |
No Comments »
Tags: ACOG, AUGS, informed consent, prolapse repair, Urogynecologic
Mar 29th, 2013 |
By Jane Akre
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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Posted in FDA |
10 comments
Tags: Adverse Event, Class II, Class III, Dr. Benson, erosion, FDA, Food and Drug Administration, High-Risk Device, Linda Gross v Ethicon, MDND, Mesh medical Device News Desk, non-mesh surgery, not rare, pelvic organ prolapse, POP, premarket review, Stress urinary incontinence, SUI, SUI mesh, SUI mesh injuries, SUI repairs
Mar 26th, 2013 |
By Jane Akre
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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Posted in Feature |
15 comments
Tags: American Urogynecologic Society, AUGS, FDA, Food and Drug Administration, pelvic organ prolapse, POP, transvaginal surgical mesh, urogynecology
Mar 25th, 2013 |
By Jane Akre
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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Posted in Media Reports |
8 comments
Tags: Bruce Ramshaw, Dr. Bruce Ramshaw, eroded, FDA, First Coast News, Food and Drug Administration, Henry Garrard, hernia implant, Hernia Mesh, jacksonville, mesh complications, pelvic pain, prolapse stress urinary incontinence, sling, urinary incontinence
Mar 22nd, 2013 |
By Jane Akre
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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Posted in Media Reports |
7 comments
Tags: 510(k), Linda Gross, medical device, PBS, predicate device, Prolift surgical mesh
Mar 22nd, 2013 |
By Jane Akre
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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Posted in Legal News |
6 comments
Tags: Adam Slater, Appellate Division, Butler Snow, Christy Jones, compensatory damages, Ethicon, Johnson & Johnson, Linda Gross, Prolapse, Prolift, punitive damages, Slater