The FDA received nearly 9,000 complaints about predicate devices before approving a new TOT. Here is a list from the January 2007 application for FDA clearance for the Align Urethral Support. This list does not include many device-related problems like bleeding, infection, pain, dyspareunia (inability to have sex) or those on the list in the right hand column on this page.
The Align (Bard Avaulta) was approved anyway on March 21, 2007.
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Mostlyn Law alleged that Boston Scientific smuggled counterfeit resin containing toxic selenium and used it in mesh products after 2010. The FDA responded January 5, 2017 by requiring BSC to prove that the material is safe for human use and to analyze the contents of their own mesh.
In its response, FDA doesn’t recommend removal of the suspected counterfeit material claiming the removal surgery is more risky than keeping selenium in your body.
Counterfeit Class Actions:
“In addition to the mass tort docket, Boston Scientific said it also faces two class action lawsuits by plaintiffs who allege that the company used counterfeit or adulterated resin from China to make the mesh in its pelvic mesh devices and not brand-name, American-made mesh as specified in regulatory approval for the devices. It said one case was stayed to allow the Food and Drug Administration to issue a determination about the counterfeit allegations.The company said the U.S. Attorney’s Office for the Southern District of West Virginia has also requested information about resin used in the company’s pelvic mesh devices.” — Lexis Legal News Boston Scientific Has Pacts To Settle About 37
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Since the 1950’s, surgical mesh has been used for all types of internal repairs, particularly hernia repairs to strengthen the abdominal wall. In the 1970’s, gynecologist and urogynecologists began to develop and patent products which used surgical mesh to treat urinary incontinence (most often due to early bladder sagging) and later more pronounced pelvic organ prolapse. Gynecologists began to cut small pieces of hernia surgical mesh into precise shapes.
A company by the name of Versica Medical introduced a product called the “Vesica Bone Anchoring System”, which used sutures attached to small screws to urinary incontinence. Vesica’s system was one of the precursors to transvaginal mesh devices that followed, beginning with the ProteGen.
Below is a comprehensive list of transvaginal (pelvic) mesh products. Expect this list to be updated with more information like dates of use soon.
Too many surgeons are sending patients to have a CT (Cat Scan) and, when the radiologist says he/she can’t see mesh, tell the patient the mesh must have disappeared or dissolved when a CT cannot identify mesh. Plastic mesh does not dissolve. Sadly too many patients have their pain disrespected or disregarded when the problem is the doctor’s. Only specialized 3D Ultrasound with the right technician and radiologist (more on this coming in another blog soon) and specialized MRI’s with the skills to see it and read it can identify mesh.
Here is a graphic, courtesy of www.scbtmr.org that you can print out an take to your doctor.
How to see mesh with an MRI
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Transvaginal full-length or patch slings are implanted through both abdominal and vaginal incisions and secured with either absorbable sutures or anchors (miniature screws). The full-length sling is roughly two by seven-inches long. A patch is about one by two inches. Examples include: the Gynecare Prolift and the Gynecare Prolift+M.
Tension-free transvaginal tape is mainly used to treat SUI. The mesh is inserted through your vagina and two small incisions in your lower abdomen near your pelvic bone. To pull the mesh inside, using his finger to identify anatomical markers, the surgeon passes a specialized needle through the area above your pubic bone called the retropublic space, which contains highly vascular tissues and is close to your bowel and bladder. Sutures and bone anchors are not required because it relies on your own tissues to hold it in place. Example: Gynecare Exact.
The transobturator tape procedure eliminates the need for a needle to go into your retropublic space. One or two needles are placed blindly through your groin area. Your surgeon then uses a vaginal incision to help guide the tape under your bladder. Example: Boston Scientific Obtryx.
The mini sling procedure uses only one incision in the vaginal area under the urethra. The mesh is secured with two “self-retaining tips” which are punched into your obturator foramen, the site of many permanent nerve injuries. Some doctors say this reduces the risk for injuries but recent scientific literature reports an equal number of complications. Example: AMS MiniArc Single Incision Sling.
Properties of Synthetic Surgical Mesh
Synthetic materials are categorized according physical properties: composition (mono-filament or multi-filament), pore size, flexibility, and architecture (knitted or woven). Mesh used in pelvic reconstruction is different from hernia mesh in order to provide ease of use and the capability for the host tissue to grow into it while reducing your risk for erosion, infection, extrusion, and cancer.
Type I monofilament macroporous polypropylene mesh (preferred synthetic material) has a large pore size, greater than 75 micrometers, facilitates the infiltration of the mesh by macrophages, fibroblast and blood vessels (your body’s wound healing defenses). It is believed to cause less infection as your tissue grows into it. Lightweight Type I mesh has a lower density of polypropylene and is believed to cause less foreign-body response.
Type II monofilament microporous mesh – allows bacterial infiltration and it is harder for blood vessels and fibers to grow into because of the small pore size (smaller than 10 micrometers) resulting in a higher risk of recalcitrant infections.
Type III multifilament mesh – has small interstices, (less than 10 micrometers) and bacteria that is less than one micrometer can replicate within its interstices. It is less than optimal because it allows access to macrophages and limits your ability to fight bacterial colonization within the spaces. There is also an increased risk of bacteria adherence due to increased surface area of the mesh (biofilm).
Type IV meshes – are sub-microporous coated biomaterials with pores of less than one micrometer. They are generally avoided in pelvic reconstructive surgery.
“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. She welcomes any input you may have.
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, check the list of support groups here.
Subscribe to PelvicMeshOwnersGuide.com to learn more about pelvic mesh. I’d like to hear from you if you are helped by what you read here or if you need to know more about any particular topic. Comment below or email me privately at email@example.com.
I just responded to an extremely cocky Endo Pharmaceuticals sales representative. They aren’t the nicest, nor brightest. He was saying some pretty nasty things about one of the first surgeon to sound the alarm about mesh, Dr. Ostergard, and the women who get the mesh– how they are all just trying to have their big payday….HAH….as if.
My reply wasn’t as good as I’d wanted, but I believe he got the point.
Here is Sandra’s reply:
If you are a sales person for any of these medical devices, kits, etc, you really don’t want the truth now, do you? Do you have children? Or if you are a male sales rep, do you have a wife? Knowing how disabling this mesh (and all mesh) can be would certainly give me pause. I would love to believe that you all really do care, but to be honest, I doubt any of you really of you do—not until it hits home.
I do believe in order to obtain the jobs you have, you must have a basic idea of biology, and how things work. If not, you shouldn’t be in this field. As corrupt as it already is, you’re not doing anyone a favor.
Now, back to your wife, or God forbid your daughter, niece, or Mom. Would you want a surgeon with so little skill that she merely attended the weekend cadaver course to learn how to implant a product that is made of the same material as a hula-hoop? There is oil in them there mesh kits.
Do you know what polypropylene does to your system? Well, it’s not inert as the makers would want you to believe. No. It shrinks, it scars, it wraps itself around really important organs like your bowel or bladder. I had mine cutting through my urethra. The surgeon had to scrape it off my bladder and, for eight hours, he tried to get that crap out because very well meaning surgeons who can implant this crap were never given a single lesson on how to take it out. Not until only recently have just a handful of qualified surgeons been able to remove this crap.
Now, once again, I ask you this question: Look at your beautiful wife, daughter, or whichever female has ever meant anything to you. Would you seriously want this crap in any of them, knowing they have a 40% chance of erosion, foreign body reaction, pain that is equivalent to giving birth, having cancer, or wanting to die but knowing that dying would just hurt their babies more?
Think about what you’re doing to women. Please try to find that place where you were when you began working in this business and wanted to make a difference.
They called Dr. Ostergard a dinosaur. They tried to make him irrelevant. He’s not irrelevant. I wish that ten years ago, when I was brutally assaulted by a seemingly well-meaning surgeon, I had access to his papers. Ostergard knew the ramifications of using mesh. He tried to warn everyone yet he was laughed at. He is not laughed at all that much anymore. More enlightened surgeons are “getting it.” But, despite his warnings, Ostergard could not stop that money making machine from rolling out all over the U.S. and on into the world.
My surgeon was just “trying to help.” She had a miracle cure for me. “Hey,” she said, “it is the ‘gold standard,’” but she never mentioned what it was made of. I had the surgery because I trusted her. Then I trusted her while she operated on me unsuccessfully three more times to cut here, snip there—never removing it.
I finally found a real surgeon competent enough to remove this stuff. He likened it to removing gum from hair, or rebar from concrete. That eight-hour surgery has done little for my pain, but it’s out. My surgical report reads like someone has been brutally assaulted.
I no longer attend soccer games or honor assemblies. Once I was extremely active, now I lay in bed most of the time—only occasionally going out with my trusty walker. This is the face of mesh. It’s not too pretty. My kids will never have what I worked so very hard for them to have: A normal childhood, that’s all.
Now I ask you one more time. Could you do this to someone you love?
I can’t wait for the little pricks answer.
Were you told a bladder sling is an “easy” solution to a leaky, overactive bladder or pelvic organ prolapse? Easy for the surgeon, maybe, but not so easy for thousands of women. Today’s story about mesh trouble is about vaginal scarring, which can make sexual intercourse difficult, even impossible, cause deformities and increase pain.
Scar tissue, made of collagen, a fibrous tissue that replaces normal tissue after any injury and can adhere to skin, muscle, or connective tissue. It pulls on the surrounding tissue, making it taut and restricting blood flow. It causes pain when it impinges on nerves or restricts the flow of oxygen-carrying blood to an area. Merely cutting the vagina open and sewing it shut in order to implant mesh leaves scarring—adding polypropylene mesh separates the healthy tissues, causing it to struggle to heal and leaving more damage behind.
Anatomy of a vaginal scar: Even though plastic mesh has been implanted since 1998, scientists really don’t know what they are doing to your body, writing in 2013: “Meshes are widely used in prolapse surgeries to improve anatomical outcomes with little knowledge of the impact on the vagina. Like all organs in the body, the vagina is comprised of several protective layers: adventitia, subepithelium, and smooth muscle layers. Disrupting those important tissues causes scarring. The tissue surrounding the vaginal consists of key structural proteins: collagen, elastin and smooth muscle myosin. These help the vagina to move, stretch and maintain support for its own structure. The introduction of surgical mesh tho those proteins has the potential to send them into chaos. The more pliable the mesh, the less disorganization occurs in the protective layers. Softer meshes have been recently introduced but they continue to elicit a foreign body response (rejection activity) and encourage thinning of the protective environment which can lead to vaginal erosion. The 2013 study reported: “Possible mechanisms include the innate immune response and chronic microinjury from mesh micromotion.”
Treatment: Some doctors tell patients that if there is no pain, no dehiscence, no erosion, there will be no treatment. For women who have endured many surgeries trying to relieve mesh comlications, scarring is an enormous issue.
There are a number of treatments available. If the scar is due to infection, antibiotics can reduce infection and inflammation. Estrogen cream and pessaries can improve blood flow and nerve supply to your vagina and promote healthy healing.
The scar can be taken out and the area sewn closed again with newer and smaller sutures—like those used in plastic surgery. Lasers can be used in small areas to dissolve the abnormal tissue and some surgeons combine both modalities.
Physical therapy (PT) can make the tissue more flexible by massaging it or applying ultrasound. Scar tissue massage can be extremely painful and re-traumatizing. Some women cannot tolerate it. For those who can, many report that after months, they find it helps lessen scars.
If you’d like to join an online support group and learn about mesh problems, partial removals, surgeons, or just find out that you are not alone, check the list of support groups here.
Subscribe to MeshTroubles.com to learn more about pelvic mesh. I’d like to hear from you if you are helped by what you read here or if you need to know more about any particular topic. Comment below or email me privately at firstname.lastname@example.org.
Besides holding your healing process back, a surgical wound infection can make you very sick, disfigure you, create fistulas require more procedures and surgeries or make a mess of your plans for the future. Synthetic surgical mesh intensifies your risk of infection after surgery because it drags bacteria into the deep recesses of your body and then acts like an over-generous host, allowing several difficult and stubborn types of bacteria to grow and multiply on its surface. Manufacturers have adamant about changing the mesh composition rather than finding a more natural and less toxic remedy for SUI (stress urinary incontinence) and POP (pelvic organ prolapse).
A surgical site infection is a nosocomial infection (hospital-acquired) that can occur within 30 days after surgery. Mesh-related infections, the most common complication after mesh surgery, cause “significant morbidity,” which, in plain English, means it makes you sick, very sick and for a long time. Nosocomial infections come under careful scrutiny by the State and Federal agencies. Over 3 million people have mesh inside their bodies and many of them want it taken out. However, the danger of stirring up the “germ soup” surrounding mesh implants should be considered before planning pelvic mesh removal surgeries.
While wound infection is a complicated topic, today blog offers an overview and links to a few articles about pelvic infections from established medical journals. You are welcome to print them and take to your doctor.
Cause: The environment in your vagina is different from the what’s on your skin—where most surgeries begin. Even when the cut is made abdominally, through your skin, for transvaginal mesh surgeries, the connection with your vagina is made inside your body. That makes you more vulnerable to the kinds of bacteria that like to live inside your vagina. Some vaginal bacteria hate light and love warmth so when they get pushed inside the deep pelvic spaces they continue to thrive and cause trouble. They form a bacterial wall called a biofilm on the surface of the mesh where the body’s natural defenses can’t reach. There are often several different bacteria causing a post-op pelvic infection, and these may include: gram-negative bacilli, enterococci, group B streptococci, and anaerobes. (More on those in a later blog.)
Types of pelvic surgical site infections: The three most common post-operative pelvic infections are vaginal cuff cellulitis, pelvic cellulitis, and pelvic abscesses. The infections, in order of severity, can be superficial, deep, or within the organ space.
A superficial infection, vaginal cuff cellulitis, involves the skin and subcutaneous tissue (just under the skin). You may feel pain or tenderness, localized swelling, redness, or heat over the area. Deep infections, pelvic cellulitis, involve the fascia, muscle, etc. You may have thick, yellow or brown drainage the wound, a spontaneously dehiscence or your surgeon may deliberately open your wound to allow drainage, fever over 100.4F (>38°C) degrees, pain in the surgical area, or tenderness. Lastly, you may have a deep abscess, pelvic abscess, requiring drainage. Infections involving organs and spaces around organs produce purulent (containing pus) drainage from a surgical drain, abscess, and include the signs of infection above.
Tests used to identify the extent of the infection include a thorough examination by your surgeon, or radiological exams like ultrasound, CT (computerized tomography), MRI (magnetic resonance imaging), or exploratory surgery. Your surgeon will probably take a culture of the wound to find out which bacteria is causing the infection and to prescribe the right antibiotic(s).
Risk Factors: You may be at greater risk of developing a post-op infection if you have diabetes, especially if your blood sugar goes over 150 mg/dL just before and after surgery or your hemoglobin is over 6.5% just before surgery. Other risk factors include obesity, (BMI> 30), anemia, prior strokes, tobacco, steroid use (like prednisone), malnutrition, increased age, prior radiation treatment to the site, or vaginal infection. The longer you are in the hospital before your surgery, the higher your risk for post operative infection.
Let your doctor know if you’ve had any recent bacterial infections. When you minimize your risk factors, you lessen your chance of getting a post-op infection.
Pre-op antibiotics: Before the invention of a process of giving pre-op prophylactic antibiotics, as many as 33 percent of patients ended up with pelvic infections. After prophylactic antibiotics were introduced, the number of infections dropped to 2.7%. Before pelvic surgery, ask your surgeon what is the plan for your antibiotic prophylaxis.
The most common prophylaxis follows the American Journal of Health-System Pharmacy recommendations: Cefazolin be given within an hour before or hour after the first incision. If the surgery goes longer than 3 hours, they repeated doses. Larger doses to be given to women over 265 pounds (120 kilograms). Chart of antibiotic guidelines here: Table 1 and Table 2 If you are allergic or resistant to one antibiotic, other ones can be given. Table 3 is a list of recommended antibiotics for pelvic mesh surgery infections separated by depth of infection.
If you are suffering from a pelvic surgical infection, take gentle care of yourself. Plan to rest, and take plenty of non-caffeinated, low- or no-sugar fluids. Eat the foods your mother made you finish: fruits and vegetables, proteins. Take multiple vitamins. Gather around you your most nurturing friends and relatives and send any annoying visits out to run errands. There are several support groups you can join to gather encouragement as you go through the long and slow process of of healing. May it be rapid.
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Mesh is a moving, writhing, migrating, twisting, grasping, destructive device that continues to harm as long as it is inside the human body and leaves permanent damage behind when it is taken out. Thousand of people with mesh trouble are not finding any help or even sympathy inside the doctor’s office. One patient after another says that her doctor said her pain, nerve damage, difficulty urinating, prolapse, fatigue, etc., could not possibly be from her pelvic sling or hernia mesh because the mesh is “inert.” That is plain out not true.
In his letter to the New Zealand Parliament, Dr. Vladimir V. Iakovlev, MD, FRCPC, FCAP, anatomical pathologist and director of the Cytopathology Department at St. Michael’s Hospital in Toronto, Canada, debunks this fallacy through very credible research findings.
After placing about 230 explanted mesh, approximately 150 of them transvaginal mesh, under a microscope, he found degradation, nerve damage, curling of the edges of the mesh causing deformities (especially with TOT mesh), migration of the mesh into healthy organs causing vaginal, bladder, and bowel problems, shrinking of scar tissue causing deformity and over-tightening, and increasing changes in aging bodies.
In a departure from previous pathologists’ examinations, Dr. Vladimir V. Iakovlev, MD, FRCPC, FCAP looked at the connection between the complaints from the patient and how the mesh appeared under his microscope. Where patients complained of pain, he discovered tiny bundles of nerves had grown into the mesh and became entrapped, forming tiny traumatic neuromata, thus validating the experiences of hundreds of women who were told the pain was not coming from the mesh.
The outside of the implanted plastic mesh becomes brittle and leachable to surrounding tissue and can enter the bloodstream where it can release toxins. The part of the mesh that touches the woman’s bodily tissue—become brittle and more porous to the dyes put on it during the pathological examination. Iakovlev recommends the mesh be easily removable, especially in younger patients. Transvaginal mesh is known to be implanted in fertile women.
2. Compartmentalizing nature of the mesh.
Mesh is made by knitting or weaving together stands of polypropylene plastic which leave small openings in which new tissue grows. Each pore can act as a “tunnel’ or constriction point for the nerves and blood vessels which grow between the strands. As the mesh folds, it forms new “compartments” filled with living tissue which can become compartmentalized, a serious injury.
3. Device migration.
Contrary to a recent explanation by a mesh explant surgeon, mesh migrates. After implantation and a return to normal, every-day movements like walking, running, evacuating the bowel and bladder, or sexual intercourse, transvaginal mesh moves into and through the walls of the urethra, bladder and rectum. The damage has been found in the muscular layer of the organs, neural ganglia, nerves and arteries.
4. Device deformation (mesh curling/folding).
Bladder sling mesh edges curl into complex folds and every single explanted pelvic organ prolapse devices bunched up causing mesh exposure in mucosal tissue. The deformed mesh parts become encased in scar tissue forming “bulky, firm, and irregular structures.”
5. Scar contraction.
Scar tissue contracts bringing the mesh fiber with it as it matures and shrinks. The device can be pulled too tight or become deformed. Newer hernia mesh has been invented to minimize the forming of scars but the pores in those mesh are too large to be used for midurethral (pelvic) mesh slings.
6. Long term effects and risks.
With mesh being implanted in young folks, life-long risks are important and neglected topics. Can it be safely removed? While most physicians shy away from removing the parts planted deeply into the obturator spaces, removal should continue to be a major concern for decisions to receive an implant or for future research by professionals.
Subscribe to MeshTroubles.com to learn more about competent removal surgeons who will remove mesh from the obturator spaces.
This blog contains first-hand opinions about pelvic surgical mesh from a calliope of experience: from 8 years of meetings, phone calls, emails and social network with mesh victims, interviews with surgeons, years of front-line emergency nurse work and early work in biostatistics and medical research, to walking the mesh walk today. I’ve learned about the magnificent inner strength of women facing unparalleled and unimaginable pelvic injuries and, along with it physical, emotional, social and spiritual challenges that would buckle the knees of the bravest soldier. These women inspire me in their tenacity and unwillingness to let go of the true joy in their lives.
To those women, I dedicate this blog.