, Dec. 19, 2019
/PRNewswire-PRWeb/ -- More than 20 years and billions of dollars in profits since their introduction, medical devices designed to treat pelvic organ prolapse (POP) and stress-urinary incontinence (SUI) have condemned women worldwide to death or a debilitating life of chronic pain and injury – leaving most victims without recourse and mesh makers with "lessons learned" and no serious consequences.
SHREDDING MESH'S WALL OF SILENCE ABOUT FLAWED DEVICES & VICTIMS WITH CATASTROPHIC, OFTEN IRREVERSiBLE, INJURIES
In this book, authors Jennifer Banmiller
and Alicia Mundy
tear down the curtain of secrecy and deceit that enabled device makers to thrive while knowingly mutilating the millions of women who entrusted mesh to help, not harm, them. "Crystal Mesh" raises grave concerns about health care's lack of checks and balances and advises patients to become their own advocates.
"OFF LABEL" SHOULD MEAN "HANDS OFF" UNTIL TESTING
"Crystal Mesh" is a wake-up call. For many years, mesh, which is essentially plastic similar to fishing line, was used in the treatment of hernias. Multinational companies realized they could profit exponentially by commoditizing the vagina and expanding mesh's use to address embarrassing female situations. They positioned a slight drip of urine after laughing as a major issue for childbearing or mature women.
These companies identified a market segment of 13,000,000 baby boomers who would develop incontinence. They then paid medical consultant doctors millions of dollars to promote implantation of mesh worldwide. This brilliant marketing strategy proved immensely profitable by targeting human traits such as insecurity and greed.
TEFLON DONS IN FIGHT AGAINST MESH
For decades, pharmaceutical and medical device makers have funded and lobbied trusted regulatory agencies, medical associations and lawmakers in order to get their products to market, without randomized clinical trials or pre-market authorization, before their competitors can cash in on "new and improved" versions of products once approved and later recalled by the FDA.
Mesh makers need for speed to market left no time for clinical testing on women, despite warnings of potentially deadly side effects from their internal medical experts – making women victims to untested experimental products and surgeries by unskilled doctors in a culture of profit over people.
Sales representatives for medical device manufacturers persuaded doctors to conduct a 30-minute mesh procedure, that was outside their field of expertise, with false promises of safety and simplicity of technique. They recommended a speedy repetition of insertions as the key to mastering the procedure. No one was ever taught how to remove the mesh.
To this day, there is no protocol to remove mesh. According to Dr. Tom Margolis
, "Extirpation of vaginal mesh is akin to taking a hammer and chisel and trying to remove the rebar from a sidewalk while leaving the cement otherwise intact and not damaging the water mains and powerlines below. It is difficult, if not impossible, to remove all the mesh and do it safely."
BIG BULLIES, BAD MEDICINE, BIG PROFITS
Bullying by these same mesh makers forced medical associations, who relied on their money, to omit the word "experimental" from bulletins because experimental procedures are not covered by third-party insurance. They did not share horror stories about mesh from around the globe to any U.S. stakeholders – the FDA, medical associations, doctors and, especially, medical consumers – because this information would "kill" their business.
CASHING IN ON WOMEN'S REPRODUCTIVE SYSTEMS
Women continue to suffer punctured bladders, severed urethras, paralyzation and permanent limps due to nerve damage from the rasp-like vaginal mesh that migrates through vaginal walls to damage surrounding organs. Recently, doctors have also linked autoimmune diseases to mesh. As an added bonus, the penises of many victim's partners were slashed by the eroded mesh. Mesh was not only life-changing; it is life-destroying.
These harrowing stories are the human casualties in the rush for companies to sell medical devices based on flawed predicate products already banned by the FDA.
"Crystal Mesh" documents how greed placed profit over health and turned the essence of a woman into a high-worth commodity ripe to yield mind-altering profits. It also provides examples of how other countries and excellent physicians are helping women -- the veterans left behind in the "gold rush" of mesh. Most importantly, this chilling book reminds buyers to beware and patients to advocate for their own rights.
510(k) GOLDEN LOOPHOLE
During the 1990s, government deregulation was designed to stimulate economic prosperity and fast-track innovative products to consumers. Unfortunately, this climate of deregulation set the stage for major crises in the financial, housing and pharmaceutical industries. In the medical device arena, it created a golden loophole for new products to bypass the 510(k) requirements of the Federal Food, Drug, and Cosmetic Act.
If a product could be proved "substantially equivalent" to a device that had been previously "approved" by the FDA's Medical Device Office for marketing, the "new and improved" device could go be sold to the public, even if its predicate product was ultimately "banned" for safety reasons.
Clinical testing, usually performed on pigs, rats and human cadavers, was not required for a product that would be permanently implanted (without a procedure developed to extract it) in women seeking help with prolapse or stress urinary incontinence. For most of the women who developed serious complications, there is no way out. For more information, please visit http://www.crystalmesh.com. ###
SOURCE Jennifer Banmiller
and Alicia Mundy