“For the want of a nail the shoe was lost,
For the want of a shoe the horse was lost,
For the want of a horse the rider was lost,
For the want of a rider the battle was lost,
For the want of a battle the kingdom was lost,
And all for the want of a horseshoe-nail.” Benjamin Franklin
Polypropylene has been found to be responsible for more deaths than just mesh patients as a recent examination of MAUDE reports to the FDA reveals. Meanwhile the plastic surgical mesh continues to be sold to patients.
The FDA’s recent announcement that it would reclassify only one application for pelvic mesh is a disaster for anyone wanting to do no harm because in its statement the agency promoted the use of synthetic surgical mesh for other pelvic applications. The only way to protect women from harm and avoid severe and devastating complications is to pressure the FDA to take all synthetic surgical mesh off the market—for good. A failure rate of forty percent (between 37.8 and 44.2%) and an erosion rate of 41.5% percent (see Figure 1. Lee, SY) represents an unacceptable iatrogenic mass casualty no matter how you toss the dice. It’s not the application (vaginal vs abdominal) or the surgical technique that’s harming many thousands of patients, it’s the material itself: the polypropylene.
Polypropylene begins its life as crude oil, like any plastic product. Polypropylene is made up of a combination of ingredients combined to produce a product that will resist temperature change and keep its tensile strength when shaped into strands. Microscopically, polypropylene is a polymer—a large molecule composed of many repeating subunits. When polypropylene is stretched into a fiber, its strength is dependent on the quality of ingredients, the width of the strand, and the shape the strand.
Polypropylene is a favorite child of plastics scientists for containers, automobile parts, rugs, and countless other applications often illustrated on this blog. Patients are told the device is inert, completely safe, does not react with the body yet, it is the same material that is used to make thousands of household products, like scouring pads. Imagine taking Scotch-Brite Scrub pad and stuffing it into your most private spot.
Polypropylene reactions: Although marketers call mesh inert, when polypropylene materials come in contact with human tissue, both sides of the interchange suffer in very dramatic ways. Plastic mesh reacts, degrades, shrinks, curls, rolls, or migrates in a woman’s body. The human host is vulnerable to allergic reactions, foreign body responses, organ injury and migration of the material. If a patient reacts badly, she is in an alarming predicament: it is nearly impossible to take pelvic mesh out.
Allergic reactions to polypropylene are said to be rare and it is nearly impossible to predict who will react. Allergists disagree on what testing method to use to diagnose an allergy to polypropylene. Foreign body responses are much more common. A few pathologists took a look at hernia mesh and all of the samples they examined demonstrated rejection responses.
Although allergists believe that polypropylene carried a low allergic response, they say the longer it is left in the body, the more likely a reaction will occur. The skin is said to spit out a suture sometimes but it is nearly impossible for a body to spit out pelvic mesh.
The same material used in transvaginal mesh was once declared unfit for the human body. In 2013, lawyers uncovered emails showing that CRBard, tried to deny the company knew it was unfit until prosecution lawyers forced them to divulge secret company emails. On Thursday this week, Mostlyn Law filed an injunction against Boston Scientific alleging the corporation smuggled a resin which it added to pelvic mesh products between 2011 and 2012.
Recently, I looked at who died from mesh and tripped onto a little known fact–one polypropylene suture, Prolene, was involved in one tenth of the deaths from Ethicon Corporation products—a quarter of all suture-related deaths reported to MedWatch. Over the past decade, Prolene failures were found in 39 of 417 Ethicon product deaths yet the FDA never warned the public about the suture and there is no evidence that the agency is even aware of the problem. MAUDE event descriptions characterized failures leading to deaths from breaks in the suture or knots which unraveled. Reading the stories, I could only imagine the surgeon’s umbrage. After many hours of high-risk surgery where he carefully applied his many years of training and masterful skills to save his patient’s life, he lost his patient—through no fault of his own. A piece of polypropylene suture broke or failed. “All for the want of a nail.”
Until polypropylene is removed from all medical devices, sadly, women and men will continue to suffer and die.
Peggy Day is working on a book to combine all these stories. This is an excerpt from Pelvis in Flames: Your Pelvic Mesh Owner’s Guide. Your input is welcome to help make Pelvis in Flames the book you need to read.
If you’d like to join an online support group and learn about erosion, partial removals, surgeons, or just find out that you are not alone, join my group, Surgical Mesh or check the list of support groups here.
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