Posts Tagged ‘ Adverse events ’

Hello July- A Long, Hot Summer of Waiting

Jul 6th, 2014 | By
Hello July- A Long, Hot Summer of Waiting

Welcome to Mesh Medical Device News Desk, also known as Mesh News Desk (MND). It is a long hot summer and so far those many bellwether lawsuits the mesh community had been promised are rescheduled or off the schedule entirely.  While the heat is good for heirloom tomatoes, not so good for patience. What is
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Suffering in Silence: Hernia Mesh Patient Bruce Rosenberg

Jan 6th, 2014 | By
Suffering in Silence: Hernia Mesh Patient Bruce Rosenberg

Transvaginal mesh has been used in women to shore up pelvic organs since the late 1990s but long before that, the same polypropylene mesh was used in the treatment of hernias. In fact, it was thought that pelvic organ prolapse (POP) where the bladder, vagina, uterus or colon fall through the vaginal opening due to
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Find Your Mesh in the 510(k) Process

Nov 21st, 2013 | By

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 under
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FDA Asks Consumers to Report Product Failures

Jun 10th, 2013 | By
FDA Asks Consumers to Report Product Failures

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 supplements.
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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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Day 21: Linda Gross v. Ethicon Expert Says Prolift Did Not Injure Gross

Feb 11th, 2013 | By
Day 21: Linda Gross v. Ethicon Expert Says Prolift Did Not Injure Gross

February 11, 2013 ~  The trial of Linda Gross v. Ethicon started late in the day around noon on Day 21 of the proceedings.  Apparently legal arguments were taking place off camera and out of the ear of the jury. The case has now gone to Ethicon to refute the evidence presented so far. Remember
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Why We Are Here ~ To Put a Face on Adverse Events

Jan 31st, 2013 | By
Why We Are Here ~ To Put a Face on Adverse Events

January 31, 2013 ~ Quite simply put the reason we are here at Mesh Medical Device News Desk (MDND) is to calculate the human toll of complications from the unregulated world of medical devices. Most Americans do not understand that the vast majority of medical devices 75-90% approved in the U.S. bypass any safety and
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Day 11: Linda Gross v Ethicon: Medical Director Signs off on Prolift

Jan 26th, 2013 | By
Day 11: Linda Gross v Ethicon: Medical Director Signs off on Prolift

January 26, 2013 ~ It was Day 11 in the Linda Gross v. Ethicon trial that brought Dr. Charlotte Owens, Worldwide Medical Affairs Director for Ethicon to the stand via videotaped deposition. Her story was remarkable for the safety and efficacy information that did not make it into the Clinical Expert Report. It was her
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Boston Scientific Under Investigation for Transvaginal Mesh Sales

Nov 8th, 2012 | By
Boston Scientific Under Investigation for Transvaginal Mesh Sales

November 8, 2012 ~  A required report by Boston Scientific reveals a number of states plan to initiate an investigation about how Boston Scientific sells mesh. The information is contained in the company’s quarterly regulatory filing with the Securities and Exchange Commission, (here), issued November 6. In the report, the Natick, Mass.-based medical device company admits
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Open Letter to Surgeons Who Have Implanted Mesh

Nov 7th, 2012 | By
Open Letter to Surgeons Who Have Implanted Mesh

November 7, 2012 ~ The following is an essay by a mesh survivor who does not want to be identified. Her Open Letter to Surgeons is an important reminder that doctors have a commitment to put his/her patient first! Each of you who blatantly disregarded your patient’s pain and suffering has broken the oath, “First,
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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.