Urinary Incontinence

Vaginal Mesh Complications
We’ll Clean Up Another Doctor’s Mesh

If you are reading this from somewhere on planet Earth, you are aware of the newspaper, radio, and television ads notifying you about the vaginal mesh litigation. Here is the condensed version of what happened and what is currently happening: Synthetic materials in the form of sheets have been used for decades to repair abdominal hernias. Approximately fifteen years ago gynecologists and urologists began to use the most common hernia mesh material, polypropylene, in the treatment of vaginal hernias, also known as Pelvic Organ Prolapse (POP). The general thinking was that this synthetic material would provide a more durable treatment.

Realizing that a growing number of expert pelvic surgeons were implanting mesh to treat POP, Medical device companies did some simple math. They multiplied the number of patients undergoing Pelvic Organ Prolapse surgeries being performed each year (by non-experts) by the profit per piece of mesh. The resulting dollar amount was apparently quite attractive. The device companies quickly developed POP “mesh kits” for general gynecologists and general urologists. These were designed to be “DIY” kits (do it yourself or see-on, do one kits). The manufacturers utilized a fast-to market FDA process known as a 510K. This process does not require elaborate clinical trials or testing. For the most part, it requires that the manufacturer demonstrate that their product is similar to other products already on the market. As you might imagine, this allows for quite a bit of finagling. The swarms of devices salespersons hit the streets, and soon tens of thousands of women would be treated with vaginal mesh kits.

The results have been devastating; it is our estimation that hundreds of thousands of women have been injured. The following is a discussion of the resulting injuries, how they occurred, and possible treatments. This discussion is a result of our review of over 100 medical papers, review articles, abstracts, legal documents, publically available corporate documents, and discussions with other national thought leaders. Please understand that although based on our research and review, some of the information contained herein includes our opinions.

 

Dr. Zipper Explains Vaginal Mesh Complications

 

Why Mesh Complications Occur

All surgeries are associated with known complications. When the devices and products used in a surgery have undergone rigorous clinical testing and have been proven to be safe and effective, complications should be those associated with human limitations. These limitations include the skill of a well-trained surgeon and a patient’s health. Most patients believe that they have a well-trained skilled surgeon and that the devices and products used in their surgery have been proven to be safe and effective in humans. If they were undergoing trans-vaginal mesh surgery, both of these assumptions were likely incorrect.

Polypropylene mesh (PPM) was never shown to be safe and effective for the treatment of Pelvic Organ Prolapse. Although PPM had been used for decades in the treatment of abdominal hernias, it was dangerous to assume that it would be fine to use in the vagina. There were numerous red flags. It had been well established that PPM undergoes substantial contraction after implantation. There was a very high incidence of chronic pain associated with abdominal mesh implantation. Many men and women undergoing abdominal hernia repair with PPM would eventually undergo surgery to treat complications or failures. The complications of PPM in the vagina would have much graver consequences.

  • There is evidence that mesh may contract up to 85% after implantation. Contraction of mesh around the vagina can pull on pelvic nerves. This will result in pelvic pain and pain with intercourse.
  • Mesh is a foreign body. Foreign bodies cause inflammation. There is evidence that mesh implantation behaves like a chronic wound with acute and chronic inflammation continuing for years. There is evidence that there is major loss of elasticity as scar tissue encapsulates mesh. Inflammation in the pelvis can lead to scarring, loss of stretch, and deformity.
  • Implantation of mesh in the vagina involves blind surgery with passage of mesh close to nerves vital to pelvic floor function, bowel function, and walking. The proximity of mesh to such vital structures can make removal difficult or impossible.

The majority of surgeons who would implant vaginal mesh were neither well trained or skilled vaginal surgeons. Unlike abdominal hernia surgery where the surgeon can see all of the anatomy, Vaginal Surgery is “blind surgery”. The surgeon is typically operating through a small incision in the vagina and can see very little. The surgeon must use his or her touch to build a 3-D picture in their mind. This is a skill that cannot be taught. Some surgeons can do it; most cannot. The original implanters of trans-vaginal mesh did not use kits. These were a small group of skilled expert surgeons implanting PPM that they shaped by their own design. When the device companies developed trans-vaginal mesh kits, these kits were marketed to general urologists and general gynecologists. These surgeons were most commonly trained in one-day courses (or sometimes not trained at all). The vast majority of these surgeons were not required to demonstrate any level of competence following their training. Additionally, their trainers underwent no competency testing. Are you beginning to see the red flags?

 

It’s a Big Mesh

Device companies mass marketed trans-vaginal mesh, a product never shown to be safe for implantation in the vagina. They offered one-day courses in trans-vaginal mesh implantation and no courses nor education on trans-vaginal mesh removal. Imagine this: Someone wants to sell you an aircraft. They get you crazy excited when they tell you that they can teach you to fly a plane in one day. They do it! In one day they teach you to take off and land. They never tell you how to land if your engines go out. Will anyone ever fly with you?

 

What The FDA Wants You To Know

FDA Notice to Public:

In 2008 the FDA issued a notice to the public, this notice informed the public of the growing number of complications being reported. In 2011 the FDA updated this notice. Here are some of the key notifications:

  • Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
  • Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
  • There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
  • While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.
  • Mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion.
  • Health care providers should recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications.
  • Health care providers should know that removal of mesh due to mesh complications may involve multiple surgeries and significantly impair the patient’s quality of life. Complete removal of mesh may not be possible and may not result in complete resolution of complications including pain.

Although the material used to perform sling surgery is made of the same polypropylene mesh (PPM), sling surgery was not part of the original or updated FDA warning. Although similar complications can occur with PPM slings, there is less mesh in a sling . This may be one of the reasons that complications of slings are less commonly reported. Nonetheless, many women do experience severe complications from a slings and all women considering sling surgery should be appropriately consented on these risks. Associated with polypropylene mesh implantation including, chronic foreign body reactions, chronic pain, chronic dyspareunia, and the potential for additional surgeries to repair these mesh-related injuries. Although less than one percent of our patients develop pain or mesh extrusion following sling surgery, please remember that complication rates vary by surgeon. You should always ask your surgeon about his or her experience and his or her personal (not national) success and complication rates.

 

The Ongoing Litigation (Mass –Tort)

Many of you may be familiar with the term class action lawsuit. A mass tort is similar. When there are numerous patients (in this case thousands) alleging that they suffered similar injuries caused by a defendant, their claims may be combined together in a mass tort action. While similar to a class action, a mass tort is different in that each injured plaintiff brings an individual claim against the defendant for the injuries they suffered as a result of the company’s action or inaction. Presently there is a mass tort for all patients who have been implanted with vaginal mesh that have made similar allegations, allegations that the manufacturing companies sold defective mesh devices and failed to provide them and their doctors with sufficient information about the severe complications associated with these mesh devices.

 

Our Treatments for Mesh Extrusion

 

Our TreatmentsMesh Extrusion (18%): This is the term most commonly used to describe post-surgical exposure of mesh. This can occur because the vaginal incision separates or secondary to erosion through intact vaginal mucosa. This is one of the most common complications. 18% is an estimation of the incidence of this complication. However, as we continue to advise you, complications vary by surgeon. As a national referral center for mesh complications, we have become familiar with surgeons who may have over 50% extrusion rates.

Symptoms Of Mesh Extrusion:

 

Vaginal Discharge, Vaginal Bleeding, Vaginal Odor, Male Pain / Partner getting scratched by mesh during sex, Sharp Vaginal Pain

 

Treatment Of Mesh Extrusion

Although there is a small amount of data to demonstrate spontaneous healing or healing aided by the use of vaginal estrogen cream, it is our experience that this rarely occurs. Your best chance at cure is surgery.

Trans-Vaginal Mesh Excision. We make a small incision around the exposed material. The vaginal lining surrounding the exposed material is typically inflamed or infected. We hence always remove the affected tissues. We remove the exposed mesh and also approximately 1 cm of non-exposed mesh. It is our opinion that this mesh is colonized by bacteria and needs to be removed. Additionally, we do not want mesh anywhere near the incision we will be closing. Although some physicians do this in their office, we are of the strong belief that the best result occurs when this is performed in the operating room where we have great lighting and can keep you comfortable. The success of this procedure is predicated on both removing infected mesh, inflamed mucosa, and closing the incision without tension. In order to do this we sometimes mobilize surrounding healthy tissue (flap surgery). Trans-vaginal mesh excision is an approximately fifteen minute procedure. The following day you can drive and return to work.

Robotic Mesh Excision. This is our procedure of choice when your mesh extrusion is high up in the vagina. We make a series of small, fingernail sized, incisions in your abdomen, and utilize the da Vinci Robot to excise the exposed vaginal mesh. We remove an additional one centimeter of mesh. It is our opinion that this mesh is colonized by bacteria and needs to be removed. Additionally, we do not want mesh anywhere near the incision we will be closing with the robot. We have over a 90% success rate with this outpatient surgery. You can drive and return to work the next day.

 

Our Treatments for Mesh Pelvic Pain

 

Mesh Pelvic Pain & Dyspareunia (12%). This is the most devastating of the complications. Pelvic pain associated with mesh most commonly begins weeks, months, or years following implantation. The physical properties of polypropylene mesh predispose it to colonization with bacteria and contraction. As the mesh contracts it can pull on or compress nerves in the pelvis. Additionally, the mesh can lose its elasticity. This means the muscles and tissues of the vagina can no longer stretch normally with physical activity or intercourse.

Symptoms Of Mesh Related Pelvic Pain:

 

Pressure or pulling sensation in vagina or pelvis, Rectal Pressure or pain with defecation, Pain radiating down your legs, Pain with walking or running, Dyspareunia (Pain with intercourse), and Groin pain

 

Treatment Of Mesh Related Pelvic Pain

Although some patients will benefit from pelvic floor physiotherapy, approximately 75% of patients referred to us for mesh related pain undergo surgical intervention. When considering pelvic floor physiotherapy, we urge you to find an expert physiotherapist. There are many physical therapists that dabble in pelvic floor physiotherapy. You will need a physical therapist who specializes in pelvic floor pain and who is trained in vaginal therapy. Dr. Sherri Loraine, PhD, DPT is our director of pelvic floor physiotherapy and has provided great relief to many patients referred to our center.

Physical Therapy

When considering pelvic floor physiotherapy, we urge you to find an expert physiotherapist. There are many physical therapists that dabble in pelvic floor physiotherapy. You will need a physical therapist who specializes in pelvic floor pain and who is trained in vaginal therapy. Dr. Sherri Loraine, PhD, DPT is our director of pelvic floor physiotherapy and has provided great relief to many patients referred to our center.

Trans-Vaginal Mesh Release

We will perform a gentle but thorough vaginal examination. Almost always we can identify the area or areas of mesh associated with your pain. Gentle pressure on these areas often duplicates your pain. The vast majority of the time we find that the pain is caused by an area of mesh that has contracted and is under tension, pulling on your muscles and nerves. We will then take you to the operating theater and, under general anesthesia, create an incision over the previously identified area of mesh. We very carefully expose the mesh and cut the tight band of PPM. The release of tension is immediate and obvious. Many patients tell us that they notice an improvement the moment they awake from surgery. The mesh lies extremely close to nerves that are vital to walking. Unfortunately this proximity to important nerves can sometimes prohibit a successful surgery.

Robotic Mesh Release

Gentle office examination is used to help identify areas of mesh under tension. When such areas are difficult to reach through a vaginal incision, or if you have failed a previous vaginal surgery to treat your mesh pain, or if your mesh lays too close to vital or blood vessels of the pelvis to allow a blind vaginal surgery, we will perform a robotic release. You will be taken to the operating theater and placed under general anesthesia. We will then make a series of fingernail-sized incisions in your abdomen. We will then utilize the da Vinci robot to macroscopically identify and cut the areas of tense mesh. The release of tension is immediate and obvious. Many patients tell us that they notice an improvement the moment they awake from surgery. The majority of patients experience significant relief with Robotic Release.

 

Our Treatments for Mesh Infection

 

Mesh Infection (10%). Mesh related infections may occur in different forms. There is now evidence to suggest that the majority of vaginal meshes become colonized by bacteria at time of implant. Early infection may lead to mesh extrusion. However, we now know that this bacteria can form a film that allows the bacteria to live on the mesh for months or years. Some patients may hence develop late infections. This may result in mesh extrusions or abscesses (pockets of puss) months or even years after your original surgery. Additionally, there is data to suggest that chronic infection contributes to contraction of the mesh with resultant pain. Although some patients with mesh related infections may have intermittent fevers and elevated white counts, many patients will have only local symptoms.

Symptoms Of Mesh Infection

 

Vaginal Discharge, Vaginal Odor, Pelvic Pain, Dyspareunia (pain with intercourse), Mesh Extrusion.

 

Excision Of Infected Mesh

Mesh is considered a foreign body. Infections of foreign bodies are very difficult to treat. Foreign bodies often have tiny spaces that create great hiding spots for bacteria. These hiding spots may be so small that antibiotics cannot penetrate. Even the simple adherence of bacteria to a foreign body makes treatment difficult. Secondary to this, simple antibiotic treatment is often not effective.

Surgical Excision Of Infected Mesh

We utilize both trans-vaginal and da Vinci Robotic approaches to the surgical excision of infected meshes. Our goal is to identify all areas of inflamed vaginal and pelvic tissue, remove the mesh beneath this tissue, and remove as much of the surrounding mesh as possible. Severely infected and necrotic pelvic tissue is also removed. We believe that the success of this procedure is predicated on the removal of the colonized mesh. Once the colonized mesh is removed antibiotic therapy is typically effective. Vaginal mesh infection is a serious complication and has even led to necrotizing fasciitis. Hence, antibiotic therapy is tailored to bacterial cultures and also to include coverage for bacteria known to cause serious infections. Additionally, antibiotic therapy is typically continued for many weeks following the excision of infected mesh.

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