New Hope for Mesh Patients

//New Hope for Mesh Patients

New Hope for Mesh Patients

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.]

By | 2013-02-19T21:48:27+00:00 February 19th, 2013|Op-Ed|10 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.


  1. Kathy February 21, 2013 at 10:56 am - Reply

    Just very thankful reading this Op-Ed that we may be moving forward in doctors addressing what we mesh victims are dealing on our own. We need the medical community to begin helping us figure out what mesh has done to our bodies and health. We have a difficult time walking. We miss being sexual. We are afraid. We feel alone. We are all very tired from trying to solve this on our own. The road has been very long.

    • Teresa October 29, 2017 at 7:45 pm - Reply

      I am suffering so very bad. 7 years now. The doctors, ER, & insurance will not help me. I am on Anthem (ACA) & no one will take that insurance that is qualified enough. Dr. Miklos & Morre said they will not help me & so Did UCLA Health where Dr Raz & Dr Kim are. I will die I am afraid because I am poor & do not have $150,000.00 -$200.000.00 required per surgery. My FNP will not even try to find me anyone & Anthem is not helping me either. I have emailed & Tweeted the Doctors & Travis Stork, Dr Phil, Robin McGraw Dr Oz, Steve Havey, Oprah, Mark Warner, Tim Kaine, Terry McAuliff, President Trump, VP Milke Pence ,the Today show, Kathie Lee & Hoda, 60 minutes, & just about every singer & celebrity, & preacher I can think of begging for help. I have also called .
      No one cares in the whole world & I am going to die. I can not sit up. I bleed. I can barely walk & I suffer so bad. I can not even take pain meds.
      Please Help me!
      Please pray for me!

      • Jane Akre November 2, 2017 at 1:25 pm - Reply

        Teresa, It seems you are facing many roadblocks. Perhaps there is a way to get your insurance to cover your needed medical expenses… write me if you want because I’ve not heard of this… Anyone else have anthem?

  2. Marian February 24, 2013 at 11:51 am - Reply

    Dr. Spellberg,

    Is this technology different than the translabial sonogram that Dr. Raz uses to visualize the mesh? If so, in what way?

  3. Jane Akre February 27, 2013 at 1:36 pm - Reply

    Dr. Spellberg Replies:

    The difference in technology is that the the Niris uses near infared light while ultrasound uses sound waves. Studies have shown that OCT has 10 times higher resolution than high frequency ultrasound, and 100 times the resolution of standard ultrasound.

  4. Matt Hermes February 27, 2013 at 2:58 pm - Reply

    Confirming Dr. Spellberg’s opinion, I note that OCT is being used in clinical trials of an Abbot synthetic vascular stent to evaluate the position and the degradation pathways of the implanted stent. The data I have read in the literature is far better than that obtained on synthetic implants by other methodologies.

    Dr. Matt Hermes

    Clemson University, Department of Bioengineering

  5. DebC April 6, 2013 at 8:25 am - Reply

    You mentioned that this testing:

    ”provides a useful tool in distinguishing between inflammation, benign lesions and/or dysplasia”

    As someone who has been suffering mesh complications after a TOT mesh implant in 2012, I’m finding this article very interesting. I was actually told I have minor hip dysplasia when I first started seeking help with severe groin/hip/leg pain after the TOT implant. I was referred to orthopedic doctors who were suggesting I may need major hip surgery. However, it was not clear at all if my pain was from the dysplasia or from the mesh damaging my obturator muscle/tissue. I had MRI & xrays, but things were still not conclusive.

    I wound up going to UCLA for full mesh removal 3 months ago. There they could do the translabial ultrasound prior to mesh removal surgery. Between that & the surgery it was found that the mesh had eroded through my tissue & attached to my pelvic bone. I also had severe inflammation & FBR. I am still trying to recover.

    I can see where having a test like this would be very helpful.

    Is there any kind of listing on what doctors/medical centers are now utilizing this new technology?

    • lynn June 12, 2013 at 10:10 am - Reply

      Hi Debc,

      How are you doing now? I have also made an appt for UCLA. I am so confused on whether to have the mesh out. I have had differing opionions from the specialist in the midwest. I had the complete Prolift graft back in 2008. I didn’t have any problems until 2012. Now I have vaginal erosion, groin/buttock pain…etc. My mesh has been in so long….I am worried about having it removed. Are you glad you had yours removed? Are you better?

      Thanks…just praying to make the right decision. I do not want another sugery to be worse off than I am now!

  6. lynn June 12, 2013 at 10:00 am - Reply

    Is this actually being used somewhere in the US for mesh complications? Where? What Dr? What medical center?

  7. Rhonda November 24, 2014 at 9:57 am - Reply

    I need answers please help. Doctor to remove the mesh implant

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