Posts Tagged ‘ FDA ’

Biomedical Expert on Regulatory Parellels of Pelvic Mesh to Breast Implants, Federal Preemption and There’s No Medical Grade Mesh

Jan 13th, 2016 | By
hyman cropped

MND, January 13, 2016 ~ Dr.William A. Hyman, a Biomedical expert has been brought in as a consultant in some pelvic mesh cases.  Dr. Hyman compares FDA’s reclassification of POP (pelvic organ prolapse) mesh to class III as a parallel to breast implant reclassification.  It forced them off the market, but they came back after anecdotal data,
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Broadly Covers Transvaginal POP Mesh Issue with MND Input

Jan 7th, 2016 | By
From VICE

Mesh News Desk, January 7, 2015 ~ Your editor, Jane Akre was interviewed for this January 5th story in “Broadly” a unit of the HBO show VICE. Read the story here.   Reporter Gabby Bess was seeking a comment on the new Food and Drug Administration rule that reclassifies mesh used for pelvic organ prolapse
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FDA Rules To Reclassify POP Vaginal Mesh as High Risk!

Jan 4th, 2016 | By
Uphold, Boston Scientific, still on the market

January 4, 2016 ~ An expert panel convened by the U.S. Food and Drug Administration (FDA) decided in September 2011 that mesh used to treat pelvic organ prolapse (POP) should be reclassified as high risk from its moderate risk (Class II) status. Today, the FDA announced POP mesh would finally be reclassified as a high
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Have You Filed Your FDA Adverse Event Report Concerning Surgical Mesh?

Nov 17th, 2015 | By
maude report nov 2014

MND, November 17, 2015 ~ This woman did one year ago. She found the MAUDE database inside the FDA.  Here is the URL for her anonymous report she made after receiving the Gynecare (J&J) Prolift mesh kit.  See it  here.   You can also go to MedWatch and report your adverse event. ADVERSE EVENT What
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Bill Would Have Essure Birth Control Removed from Market

Nov 4th, 2015 | By
Essure Facebook page

MND, Nov. 3, 2015 ~ There has been a lot of organized attention by consumers harmed by the Essure birth control device made by Bayer Healthcare Pharmaceuticals. Metal coils are implanted in the fallopian tubes with the goal of having them scar over, therefore preventing pregnancy. The coils contain polyethylene fibers and are held in place by stainless
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Transvaginal Mesh- Emerging or Resolving?

Oct 14th, 2015 | By
MTMP agency wrapping up mesh

Mesh News Desk, October 14, 2015 ~ As trial lawyers gather in Las Vegas for the twice-yearly Mass Torts Made Perfect, hosted by Levin Papantonio Law, one cannot help but notice the agenda for the last day – areas ahead for future litigation or areas that are waning. As you might have guessed, transvaginal mesh
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Drugwatch: How the FDA Has Let Women Down

Sep 29th, 2015 | By
How the FDA let women down  cover

Drugwatch, a publication of the Petersen law firm, goes above and beyond in this article ‘How the FDA has Let Down Women.” The agency has dropped the ball on women’s health issues from the power morcellator to the Essure birth control device, surgical pelvic mesh and on and on.  Reporter, researcher, Michele Llamas writes an
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Four Years Ago: FDA Where Are You on Pelvic Mesh Proposals?

Sep 11th, 2015 | By
FDA logo green background 240

MND, September 11, 2015 ~ It’s been four years this past week (September 8, 9, 2011)  that the FDA convened a panel of “experts”  to form the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee. Their goal was to discuss the five-fold increase in complications associated with pelvic mesh.   The FDA
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How to Post an Adverse Event with the FDA

Aug 30th, 2015 | By
Pacemaker, Courtesy WikiCommons, Steven Fruitsmaak

MND, August 30, 2015 ~When you have a new car that develops a “safety” issue i.e. braking, steering, airbags, wiring, engine cooling, unintended acceleration etc, the auto dealer reports the problems to the manufacturer, who by law, must report the issue to the National Highway Traffic Safety Administration within five days. But when a patient
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FDA Expert Panel Meets Sept. 24 Over Controversial Essure Birth Control Device

Jul 23rd, 2015 | By
Essure, ABC, Tampa

MND, July, 23, 2015 ~ The following is from the FDA’s website.  The issue of the controversial Essure birth control implant has made the headlines. Women claim they have been injured by the implant which is made by Bayer HealthCare.  The implant is placed through the vagina and into the fallopian tube to prevent pregnancy.
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