The Food and Drug Administration cannot possibly understand just how widespread mesh complications are unless you report to the agency. Mesh patient advocate, Jen Snowden, tells you how.
Simply put, Congress has not allotted enough money for the Food and Drug Administration to do its job as a watchdog over the thousands of medical devices on the market, says a former FDA professional.
Reactions are coming in reacting to the sudden death of surgeon, researcher, and tireless patient advocate, Dr. Robert Bendavid, MD.
Mesh News Desk is trying to clear up some of the confusion concerning the 2019 FDA decision about POP mesh, essentially removing it from the market. This applies to pelvic organ prolapse mesh only!
Even though the Food and Drug Administration began taking in mesh-related complaints in early 2000, nine years later the agency decided mesh to treat prolapse is not safe or effective and banned it.
Dr. Greg Vigna, MD, JD report that Boston Scientific is seeking the FDA approval of its mesh using the 522 orders which are an FDA-ordered review of complications.
Expert Panels often decide to approve drugs and devices, but how objective are the panelists when they have financial arrangements with those they are regulating?
After a conversation with someone familiar with medical devices, she thought mesh was off the market. It is not and is still used as a first-line treatment for incontinence, despite the problems.
Pelvic Organ Prolapse (POP) polypropylene mesh, which has injured so many, has finally been reclassified as "High Risk" after giving industry another 30 months until moving it from moderate risk.
The Food and Drug Administration's 510(k) clearance process for medical devices has been called a fast-track clearance for medical devices bypassing assurances of safety and efficacy.
When Money Mixes with Medicine, Industry Influences get a Foothold with the FDA due to financial influences.
A former FDA IT project manager left the agency to focus on patient safety but to do that, she needed the real numbers of complications for medical devices, something the FDA doesn't really have.
Family Tree of Meshes, Littman, shows the origins of pelvic mesh.
Pelvic meshes found detective in a court of law remain on the market and are regularly used, specifically polypropylene mesh used to treat incontinence in women.
Questions have been raised by readers - Is my doctor receiving funds from the industry that makes the mesh or medical devices he or she is using?
A Biomedical expert has been brought in as a consultant in some pelvic mesh cases. He shares that devices taken off the market soon find a way back on at the hands of industry.
Months after the U.S. Food and Drug Administration (FDA) warned a medical device could spread deadly uterine cancers, many hospitals and doctors are still using them.
Two days before an advisory panel was gathered to look at the controversial medical device called a morcellator, a gynecologist stepped down due to conflict of interest.
Fantastic researcher and friend, Suzanne McClain has always been the most competent person in digging through the U.S. Food and Drug data on the origins of mesh.
Some of the names in this story may sound familiar, primary among them Dr. Vincente Lucente, who consistently appears as an expert for industry, while he admits to profiting about $1.7M from JNJ.
American Medical Systems (AMS) has just received FDA clearance to market a new incontinence sling called RetroArc, used to treat incontinence.
The Food and Drug Administration has an unreliable way of tracking implanted medical devices. The agency knows it has a problem so it may follow the lead of consumer products.
Liz Reece is a 48-year-old woman from Oxfordshire, United Kingdom who had a mild case of incontinence. “I went into an Oxford hospital’s pelvic clinic…
Pinnacle Pelvic Floor Repair kit The first of nearly 15,000 federal lawsuits facing mesh manufacturer Boston Scientific (BCS) will begin November 3 ...
Clock, WikiCommons Mesh Medical Device News Desk, August 28, 2017 ~ The following story underscores the importance of recognizing injury as soon as…