Dr. David Spellberg, urologist

Dr. David Spellberg, urologist

By David Spellberg, MD

As a Urologist, I have read about horrible complications such as bleeding, abdominal pain, perforated organs, and sexual dysfunction associated with certain types of mesh products and some of the terrible suffering of mesh patients.

The Food and Drug Administration issued two warnings, one in October of 2008 and another in July 2011, alerting physicians and manufacturers of the risks of synthetic transvaginal mesh, including extrusion through the vaginal wall or into organs, chronic pain, infections, scarring, shrinkage, and neuromuscular problems. It also mentioned that a return of incontinence, prolapse, multiple surgeries, and other complications were “not rare”.

Unfortunately, those warnings were not heeded and now there are significant numbers of patients with lifelong problems. Many require multiple surgical procedures; oftentimes with worsening results as in many instances the mesh cannot be completely removed.

The need for transvaginal mesh occurs for women in those cases where the vaginal lining or epithelium becomes so thin and weak that they develop pelvic organ prolapse. This means the bladder, rectum, uterus and occasionally the entire vaginal canal can drop, which requires surgery to fix.

Prior to the use of mesh, many women would have their own muscle tissue from their abdominal wall or thigh used to support the fallen organs. This was a more complicated procedure with a more painful recovery and mesh was developed as a way to address those issues. Mesh was used to reinforce the weakened muscle and tissue, but it appears there were many unforeseen problems with certain types of mesh.

Now when there is a problem with the implanted  mesh and it needs to be removed, it is a more complicated procedure and many times the mesh itself has adhered to other tissue and is not able to be seen or completely removed.

One of the big problems has been the difficulty in visualizing mesh after it has been placed, especially if removal is needed due to complications. Unfortunately, current imaging techniques such as CT scans, MRI, and high definition ultrasound have not always been as effective as needed. Sometimes these imaging modalities are not able to actually see the mesh, making it impossible to know what needs to be removed.

In fact, many patients are just given pain medications, an anti-inflammatory  and even antidepressant medications because a complete diagnosis has not been made. It is unfortunate that many patients are being dismissed by their doctors as they are told “there is nothing that can be done.”

I was recently intrigued by a demonstration of the Niris 1300e OCT scanning system produced by Imalux Corporation (here).Niris optical system

The Niris is an OCT (Optical Coherence Technology). The OCT technology is not new, but has been around for many years. The Niris has been FDA approved for tissue surveillance, and is extensively used for cancer surveillance.

In the past few months Imalux identified and through studies showed the clinical validity of the Niris 1300e in identifying the precise location of mesh in patients. (See study here)

NIRIS two mesh imagesThe capability of the Niris 1300e was dramatically superior to a typical ultrasound machine in the identification of previously placed mesh, because in addition to its being less invasive to the patient, it has the ability to scan epithelial tissue where diagnostically significant alterations in tissue structure first occur.

Also, spatial resolution of 10 – 20 microns provides a useful tool in distinguishing between inflammation, benign lesions and/or dysplasia. Niris images are acquired at a minimum of 8 frames per second making surveillance using Niris practical and efficient.

As a physician, I was extremely impressed how simple the equipment is to be trained on and even more amazed at how reproducible and consistent the results are. Where ultrasound would be influenced by the experience of the user and the quality of the machine, the Niris 1300e was able to produce the same results in the hands of different users. In the past unfortunately, many patients may have had procedures to remove vaginal mesh only to find out that a partial removal was performed due to the difficulty in knowing where all of the mesh was placed.  I believe with this new application of OCT technology physicians treating patients with mesh problems could have an easier, less invasive and more effective way to deal with their complications.

I believe this technology may also be used in the future to help identify and be used as an adjunct factor in determining whether hormonal replacement is needed in para/post-menopausal women and as a great surveillance tool for cervical cancer.

The Niris system is able to generate consistent and accurate measurements of the vaginal epithelial lining, which as explained earlier tends to thin as women age. By keeping a record of the thickness of the lining, women and their physicians may be able to follow and determine if and when hormonal treatment is needed, along with monitoring for cancer in a more effective manner.

I believe with the use of the Niris technology, many future patients can avoid these types of problems, so hope is on the way.

[Editor’s Note* Op-Ed essays are the opinion of the writer. Some Opinion pieces may be sponsored and helping to support MDND.]