Featured

Johnson & Johnson Loses Pelvic Mesh Class Action – What’s next?

I’m sure those of you who are implanted with pelvic mesh are fully aware of the ruling against Johnson and Johnson in the Shine Class Action last Thursday 21st November. I don’t want this message to be a repeat of the news stories that have already clearly explained the long 7 year wait for this outcome. Just search the internet for “Johnson and Johnson class action” and you will find articles taking up at least 6 pages of Google.

If you are not caught up on the news, here’s a link to the ABC story.

I need to clarify the ABC’s story as there is a paragraph that is misleading. It states ” She (Justice Anna Katzmann) said the devices, which were banned in 2017…”. These devices that Justice Anna Katzmann is referring to in this particular statement does not represent all of the Johnson and Johnson mesh devices. The devices that have been removed in 2017-2018 are the prolapse mesh kits that were implanted transvaginally and the single incision Mini sling.

Here is a table of the Johnson and Johnson devices that remain on the market today…

There are other pelvic mesh devices that are still on the market and they include prolapse meshes that are implanted via the abdomen, as well as other manufacturer brands of midurethral slings that are implanted transvaginally. Midurethral slings are otherwise known as TVT, TVT-O and TOT. Common names that surgeons like to deceive women with are, sling, tape or ribbon so that women don’t know they are actually about to be implanted with mesh. Dirty tactics hey!

Folks, we have all been deceived right throughout the senate inquiry. The government has been deceived. The media have been deceived and the women suffering have been deceived. Who has deceived us all? The TGA and RANZCOG, and the surgeons who run both establishments. With regards to pelvic mesh devices, the TGA is led and instructed by RANZCOG. The TGA responds to RANZCOG’s decisions. I know this. I was told this at the TGA meeting that I went to in Canberra back in 2016. Who runs RANZCOG? The Urogynaecological surgeons that insist on continuing to implant pelvic mesh devices into the vaginas of our precious women of Australia.

How have we been deceived? Well, during the senate inquiry, the TGA and RANZCOG surgeons focussed so much on the transvaginally implanted PROLAPSE mesh devices and they all agreed that these devices need to be removed from market and that they need to stop implanting them in women, that the midurethral sling which also causes significant damage to the woman’s body, got overlooked. The surgeons all got on board with the mesh clinics and the mesh committees, looking like they were doing their job. But they weren’t doing their job to protect women. What they WERE doing was making damn sure that their precious midurethral slings didn’t disappear off the market along with the prolapse meshes. As stated, these slings which are also known as TVT, TVT-O, & TOT are still being implanted by surgeons at the mesh clinics around Australia to this day.

The TGA have released a statement yesterday 26th November which you can read here

Nowhere in this statement does the TGA say that they will be removing the Johnson and Johnson mesh devices that were found to be defective and not fit for purpose by a court of law. Do you want to know why? Because the surgeons want the TGA and women of Australia to continue to believe that the midurethral sling is safe and effective and the risks are a mere 1%. By “risks” they mean possible loss of organs, nerve damage, infections, never having sex again, loss of being able to be the mother in the capacity that our children need, loss of being a wife in the capacity that our husbands need, loss of jobs, loss of extra income that helped to support that huge mortgage, loss of the old self; the self who loved to hike and dance and walk without pain, loss of mental stability; increase of anxiety and depression and suicidal thoughts. Wow, what a sacrifice to make, just to stop peeing our pants when we sneeze or jump or run.

These surgeons have invested two decades of their time learning from the manufacturers about the benefits of pelvic mesh devices because they can make so much more money in one day, than they could from the “old fashioned” native tissue repair. Why would they want to give that up! Most don’t even know how to do native tissue repair anymore. No-one is teaching them. The mesh implants are a quick 45 minute operation as opposed to a 4 hour native tissue repair operation; the hospital stay for a mesh implant is one day as opposed to 4 days with the native tissue repair; sometimes a patient can even go home on the same day after a mesh implant. Hospitals also love this device; saves theatre time and bed space.

So, What’s next?

I am not talking about what’s next as in payouts for the women. That moment will come in February next year when Justice Anna Katzmann will award damages. I am talking about what’s next for the obligations and responsibilities of the TGA, RANZCOG and our Minister for Health Greg Hunt?

What’s next, is that the TGA MUST remove ALL Johnson and Johnson mesh devices from market effective immediately. The proof is out there now, although I have to say that all of the injured women who presented their accounts of their destroyed lives at the senate inquiry should have been proof enough. The judge has stated in a court of law (meaning her judgment upholds the law), that all of these devices are defective and not fit for purpose. Minister Greg Hunt must hold the TGA and RANZCOG to account.

If Minister Greg Hunt, the TGA and RANZCOG continue to allow the implantation of pelvic mesh devices into women, they are all complicit from this day forward in the risk of putting women’s lives and health in danger.

This will be a human rights violation and the Human Rights Commission must step in and stop the madness.

Featured

The Bleeding Edge

In recognition of Patient Solidarity Day, the Health Consumers’ Council is hosting a screening of The Bleeding Edge by Academy Award nominated filmmakers Kirby Dick and Amy Ziering. The film documents an investigation into the medical device industry and shines a light on the perils of the relentless pace of innovation.

When: Thu. 13 December 2018 from 
6:30 pm – 9:30 pm AWST

LOCATION

Luna Cinemas
155 Oxford Street
Leederville WA 6007

Get your $10 Tickets here

America has the most technologically advanced health care system in the world, yet preventable medical harm has become one of the leading causes of death, and the overwhelming majority of high-risk implanted devices never require a single clinical trial.

In THE BLEEDING EDGE, Academy Award nominated filmmakers Kirby Dick and Amy Ziering (THE INVISIBLE WAR, THE HUNTING GROUND) turn their sights on the $400 billion medical device industry, examining lax regulations, corporate cover-ups, and profit driven incentives that put patients at risk daily.  Weaving emotionally powerful stories of people whose lives have been irrevocably harmed, the film asks: what life-saving technologies may actually be killing us.

The Bleeding Edge can  be watched on Netflix

Find Support Australia Wide

Facebook Groups

Australia

https://www.facebook.com/groups/AustralianPelvicMeshSupportGroup/

https://www.facebook.com/meshawarenessaustralia/

western australia

https://www.facebook.com/groups/wapelvicmesh/

gold coast and surrounds

https://www.facebook.com/groups/381211482304982/

new south wales

https://www.facebook.com/groups/284184732101402/

Websites

www.WAmeshawareness.org

www.meshawareness.org

Why laproscopic removal is not a good choice

Vaginal mesh is placed extra peritoneal. Outside the body cavity and away from bowels. Although laparoscopy is touted as minimally invasive, that is only to abdominal surgery. 

Vaginal surgery is less invasive than laparoscopic and robotic surgery. 
Robotic surgery is laparoscopic surgery aided by a computer to help the surgeon move the robotic arms. When mesh is placed vaginally and attempted to be removed laproscopically, the surgeon must place small 5mm to 12 mm incisions and ports in the abdomen. This does add a risk of injury to the bowel blood vessels as the trocars are inserted. 

Then the peritoneum must be cut and the bladder and vagina or rectum and vagina must be separated. Bear in mind that the instruments are inserted thru the abdomen. This port creates a fulcrum and the angle vertically thru the abdominal wall limits the instruments that are operating on the horizontal orientation of the vagina. 

While all this is going on you are tipped head down pelvis up so your bowels are out of harms way. The surgeon is operating standing at your side with thin 5mm to 10 mm instruments thru your abdomen to reach 17 to 25 inches from your vagina. 

Or, You can find a vaginal surgeon who can forgo all that and go directly thru the vagina to the mesh. Remember mesh was placed vaginally. The thin laparoscopic instruments were never designed for the structural stiffness of the mesh. Laparoscopic instruments were designed to be thin and delicate since bowel is always present. 

Additionally, laparoscopic surgery uses energy sources. Electricity to cut tissue and stop bleeding which generates heat. 

Mesh is plastic. Heat melts plastic. 

Due to the nonspecific delicate instruments used in laparoscopic and robotic surgery, in order to remove mesh in laparoscopic surgery, robotic energy must be used. 

The instruments are too weak. 

Removals done with the use of electricity will look blackened or burned with no clear edges or ends. And The small blood vessels need to be cauterized. 

Liberal use of energy will either melt the mesh, create a thermal injury in the tissue that will kill it days later and may result in a hole in the rectum or the bladder or in order to avoid melting the mesh, or more tissue will be removed and the chance of a hole and a Fistula will increase. 

Also, Mesh in the groins from a TOT and mesh under the skin and muscles from a TVT can NOT be accessed by laparoscopy. They need an incision.
You can do all that or have the mesh removed Vaginally with sharp dissection using more durable instruments designed specifically for Vaginal surgery. 



Written in response to inquiries about Laparoscopy By D.K. Veronikis M.D.

Your choice. 

Best chance is 1 surgery. Get out as much as possible. Preferably all of it from a surgeon with a known track record. 

You only have 1 chance to get it done right. 

Each surgery adds scar and risk of injury. 

Choose wisely.

Dr Veronikis Gives Answers

Dionysios K. Veronikis, MD, FACOG, FACS

Mesh removal is by far the most complicated and technically demanding procedure(s) a gynecologic surgeon can perform secondary to the scarring/adherence of the mesh on the delicate pelvic organs, the distorted anatomy, previously operated vaginal tissues and the mesh arms that penetrated the pelvic floor muscles.

Therefore, it is imperative that you do your own research and pursue mesh removal surgical treatment with a master vaginal surgeon, with a proven track record of successful and safe mesh removals, who is tenured in the treatment of vaginal prolapse and incontinence; and is able to remove the mesh without tissue destruction utilizing a tissue sparing removal technique by obtaining the needed surgical exposure.

Above all, it is the surgical skill set, experience and judgement of the surgeon that will make the difference for the outcomes of each particular patient and the quality of life.

When did you begin removing mesh?

I started removing mesh in 1994 while I was a fellow (1994-1997) at Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts with my mentor,Dr David Nichols. At that time it included mesh slings, mesh sacrocolpopexy as well as other uses of mesh in Gynecologic Surgery. Then, with the introduction and popularity of the TVT slings that began to be implanted, shortly after 1999, mesh complications requiring surgical management and removal procedures began to increase due to the increased  utilization of mesh with erosions and exposed mesh, as well as the failure of the sling to cure incontinence. The removal of prolapse mesh kits followed in 2005-2006 with an increased complexity due to the body and the arms of the prolapse kits and anchors.  Due to this vast experience, I have learned a tremendous amount during the last 12 years regarding mesh removal;

  • How mesh behaves in tissue
  • How the tissue responds to mesh implantation
  • How to dissect mesh strips and sheets of mesh from the thinned, exposed areas while preserving the vaginal tissue while at the same time eliminating organ injury
  • How to set up the mesh removal/explants so that I am able to remove the arms from the pelvic floor.

How many mesh removals have you performed?

I have performed over 2000 mesh removal surgeries to date that include every type of sling, prolapse mesh kit, sacrocolpopexy mesh including anchors and titanium screws.

Are you able to remove mesh off the bone?

Yes. This is actually a lesser challenge for me, as the bone serves as a solid backstop. It is much harder to remove mesh from the soft tissue walls of organs such as the bladder and rectum; it is very difficult to remove mesh from major arteries and, especially, veins.

Can you explain in detail, your surgical process of a mesh removal?

The best and invariably, the only chance to remove the mesh is with the first surgery while the mesh implant is intact and uninterrupted where the continuity can be followed.  I approach every surgery with the philosophy to resolve with one surgery the patient’s symptoms and pain created by the mesh implant and to do so to remove the mesh completely. When performing a vaginal mesh removal surgery, the trajectory of the initial implanted mesh, in addition to the type of mesh device, dictates and mandates the course and approach of the removal. The location of the mesh (vagina, abdomen, pelvic floor, groins and legs), in proximity to fragile nerves, bladder wall, rectal wall and major blood vessels, in addition to whether the mesh is exposed or eroded into an organ are always essential elements that must be considered in removing mesh with the required skill to manage all that is required at that surgery.

Another complex and difficult area of mesh removal is if the mesh is adhered to the bones. However, the more challenging side of mesh removal is locating the mesh that has been placed deep in the obturator and adductor muscles also called the groin areas in transobturator slings [1 arm in each groin] and Anterior Prolapse mesh kits [2 arms in each groin]), as these arms traverse from inside the vagina/pelvis to the outside of the pelvis and past and through the leg muscles. The depth of mesh placement in the posterior pelvis with Posterior Prolapse mesh kits (levator muscles) is another significant consideration. Frequently, removing mesh arms from the prolapse mesh kits requires dissection in the pelvis that is 11-12 cm deep in the pelvis.

Complete removal is a definition that must be understood in proper clinical context. For example, removing a mesh product that has defined ends, such as anchors will be complete if the product is removed from anchor to anchor. If the mesh implant is intact, meaning the implant is still in one piece, has never been trimmed, cut or partially excised, there is a greater chance that all of the mesh can be removed.

If the implant does not have defined ends such as slings, then the only way to know if it was removed is by finding the ends; A retropubic sling from the vaginal to the abdominal ends and a transobturator sling from the vaginal to the groin ends.

When one has undergone a previous mesh removal, by one or more attempts, it is difficult to know what percentage of mesh has been removed, and what amount still lies within the patient especially with a transobturator sling where only the groin mesh is remaining, which is very common with transobturator partial removals as the transobturator arms are very hard to remove for most surgeons, but I am able to remove them.

With previous partials, assurances can be made that more mesh can be removed however,there are no guarantees. To date, with the exception of one patient who had undergone a prior removal, I have found, and removed, additional mesh in every partial removal case.

In cases with intact prolapse mesh kits (Anterior or Posterior), the entire mesh removal process requires additional knowledge and significant surgical skill. These large kits involve multiple arms that extend from the inside of the pelvis to the outside of the pelvis through the leg muscles. Often times, these arms are imbedded into the muscles of the legs for anterior mesh kits.  The volume of the mesh is tremendous; having an obtuse curvilinear trajectory, the arms can coalesce to each other, or adhere, to the bone.

Invariably, regarding intact kits, the vaginal portion of the mesh can be removed and the mesh arms can be followed and dissected free, as far as possible into the pelvis, then groin incisions to find the other end of the mesh kit arms is required, due to the depth and pelvic path curve that the mesh has been placed.

Do you agree that partial removals lead to more problems?

I absolutely agree that partial removals are problematic. I do not proceed into a mesh removal surgery with the mindset to do a partial removal. Usually, there is pain from the arms and vaginal pain and many times exposure of the mesh in the vagina. Therefore, to resolve all the symptoms and best chance to resolve the pain, I approach every surgery with the philosophy to remove all mesh, and to do so in a complete manner. Partial removals, especially with pain from the arms, frequently do not relieve the patient’s symptoms. As mentioned the lateral arms in the levator muscles and the groins are mainly the cause of the pain. In prolapse kits, when the mesh “belly” is removed off of the bladder or rectum, and detached from the arms, the arms then become more rigid, acting like a “poker” that can further irritate the tissues – this causes pain with motion as well as with coitus and even at rest.

Are you able to remove difficult arms of the mesh in the deeper areas of the pelvis?

Yes I am and I do. Again, previous partial mesh removals add a significant variable, as the mesh arm end must be found. In the intact prolapse mesh kits with arms, the body of the mesh acts as a, “handle”, allowing the continuity of the remaining mesh and arms to be identified by this process for the arm removal which I easily direct. I have innovated and developed a surgical approach that allows me to maintain surgical exposure deep in the pelvis to visualize and dissect the mesh arms.

Please explain how you are able to find the mesh, including the implants that have been partially removed. Do you use the translabial ultrasound?

I do not find the translabial ultrasound offers any benefit whatsoever. It is not used in surgery and cannot help pin point the mesh during surgery.  The implant log defines the mesh product.  That single piece of documentation is the most essential data.

To date, I have performed all mesh removals without the need for any ultrasound.  Surgical mesh removal requires acute clinical acumen and surgical skill.

For nearly two decades, and intensely over the last decade, I have reviewed the operative reports and pathology reports to determine how much mesh was removed by a previous surgery when the pathology report exists. I have tremendous success in removing mesh that has been missed, or left behind. 

Are you able to, or have you removed mesh from the retropubic space and/or pubic bone?

Absolutely, retropubic slings require vaginal and abdominal incision to identify the ends for full removal especially after partial.

Transobutraror slings are much more difficult to remove than retropubic slings and require groin incisions. In comparison to transobturator slings, removal of retropubic slings is straightforward.

Are you able to or have you removed the anchors from single incision slings?

Yes I am able to remove the anchors. I have removed the Miniarc, Adjust and Solyx slings, including the anchors. I also remove the arms with anchors from Anterior and Posterior Elevate anterior prolapse mesh kits.

Do you remove mesh Robotically or Laparoscopically?

I do not remove mesh robotically or laparoscopically. All Anterior and Posterior vaginal prolapse kits and slings are extraperitoneal and are simply under the vaginal wall. Although, peritoneal entry with a laparoscope can access the retropubic space by cutting the peritoneum (which must be closed) but will not easily access the mesh placed vaginally between the bladder and vagina or rectum and vagina or mesh in the rectus muscles; neither will it help in accessing the arms in the levator muscles.

For sacrocolpopexy mesh I prefer the open approach. My experience has been that the sacrocolpopexy mesh is invariably wrapped around bowel. I prefer to use my hands directly and my tactile sensation with sharp dissection especially whenremoving bowel from mesh and adhesions.

For TOTs, do you make the incisions in the inner thigh area or the vagina?

Both are mandatory for transobutrator slings, TOT’s. This is also required for Anterior prolapse mesh kits; there are two arms in each groin.

Regarding sacrocolpopexy mesh, what are the complications and how do you maintain the repair so that the vaginal vault remains in its proper position?

In addition to common pelvic pain, mesh exposure in the vagina, mesh erosion in the bladder and in the rectum, I have found ureteral kinking, bowel obstruction and mesh on the iliac vessels. Once the mesh has been removed, the suspension will no longer be effective – meaning the tissues are not typically in a position to be resuspended. This requires a staged repair. After healing, I can offer them vaginal reconstruction. In every mesh removal I prepare the tissues and the surrounding tissue areas for optimal healing as well as for future reconstructive surgery. I view the mesh removal as the initial step to restoring the woman’s quality of life; therefore I am very careful to set the stage for future repair.

What diagnostic equipment do you have and use?

I have urodynamic and cystoscopy equipment that is used to assess and determine how well the bladder; sphincters and urethra are storing and releasing urine. I also have an ultrasound machine that I predominantly use to evaluate the anal sphincter muscle in women who suffer from fecal incontinence.

Do you use the Interstim for women who may have chronic pain caused by severe nerve damage?

My area of expertise and focus is on surgical management. I would like to be a master of many things, but I am content in mastering surgery. Thus, although I am familiar with the Interstim, I do work with specialists who are experts in this area as the management after the interstim requires expertise that I simply do not have and I believe my time is best served surgically.

Do you do nerve blocks or vaginal trigger point injections when indicated?

Yes I do with a combination of drugs including BOTOX.

Recognizing that there are different areas and degrees of prolapse, and varying degrees of difficulty in removing mesh, are you more likely to remove the pelvic mesh and perform the prolapse repair during the same initial surgery, or address the prolapse repair during a second surgery?

Every patient is different. I always view each patient as an individual.

The huge variability of mesh and mesh implant placement defies generalizations about any one approach. Mesh placed in the urethra, the bladder or the rectum and mesh exposures will not permit reconstruction during that mesh removal surgery, except for repairing the hole that remains in the urethra, bladder and rectum.

Generally, mesh removal is very time consuming and requires hours of mesh removal surgery especially in prolapse mesh kits and in patients that have pain. The level of dissection makes it impossible to adequately reconstruct a complete post-hysterectomy prolapse in a patient in whom I am removing previously placed anterior and posterior mesh kits with arms in the pelvic floor and a transobturator sling with groin pain. This requires a staged approach. Resolve the pain and make sure that the tissues and nerves have healed.

If the pain continues, is it the new repair sutures or the mesh removal?

Chronic erosion or exposure of mesh requires observation of this process and elimination of any infection before opening up new/additional surgical areas that can get infected.

Patients with incontinence and urinary retention and pain with intercourse from a sling are best served by a restoration back to a functional quality of life. Then perhaps re-evaluation may result in additional surgery if needed as about 50% will not leak or leak so little that these patients do not require or desire any additional surgery.

I believe this time interval allows for determination of symptoms and their resolution or persistence; evaluation of residual physiology and anatomy after mesh removal and healing in my opinion is a much better option and waiting until the tissue heals and then proceeding with reconstructive surgery.

Every woman is a unique individual and generalizations cannot be made. A woman who has a TOT, TVT or a mini sling and even a prolapse mesh kit, that has pelvic pain, pain with coitus, leg pain and continued incontinence may also have uterine prolapse or vaginal prolapse that was just not repaired completely at the time of sling/mesh kit placement. Yet again, I have also seen women that once the mesh was removed require no additional surgery.

When reconstructive surgery is indicated, I believe in repairing all the defects at one time for the maximum best outcome.

Lastly and very important, in patients who have undergone partial mesh removals, it can be difficult/impossible to find the remaining mesh and the possibility exists and is very real that the remaining mesh may not be able to be found, although this is rare in my experience.

Activating your pelvic floor from ground zero!

After my full removal of a TVT-O by Dr Veronikis in October 2014, I tried to strengthen my pelvic floor. I spent a few months doing the exercises and during that time, a friend told me about a website called Whole Woman.

I became very confused about what to do with my pelvic floor after reading the information on that site. I stopped doing my pelvic floor exercises and instead, changed my posture. I know I should have done a lot more than that but honestly, I couldn’t afford their program so I just made do with the information that I had at the time, which wasn’t a lot!  

This video explains their fundamental principles and practices. Please have a look and do let me know in the comments below what you think about this practice.

HOWEVER, I am now going through a struggle with this information because I went to a physiotherapist on Friday 23rd November due to severe pelvic pain. She found that my adductor muscles (this muscle is affected because my TVT-O was implanted through the obturator fossa) and glutes (gluteus maximus) are extremely tight and they are doing all the work to support my pelvis and my back! She said that strengthening my pelvic floor will support my pelvis and take the tension off my adductors and glutes and SHOULD reduce my pelvic pain. 

A friend on the Australian Pelvic Mesh Support Group on Facebook sent me a link to a video for pelvic floor strengthening which I have added below. Please have a look at the links and videos I have added and make your own mind up. I am going to try the pelvic floor strengthening in the video below and see if it makes a difference to my pain.

I do NOT recommend pelvic floor exercises whilst mesh is still in your body. I also do not recommend physiotherapy whilst mesh is still in your body. These exercises are for women who have had full mesh removal or who do not have a mesh implant at all. I am sorry if you still have mesh and you are having complications. I have always only recommended one surgeon, Dr Veronikis in St Louis.

Please contact Dr Veronikis directly if you would like more information about his incredible mesh removal skills. I have seen many, many pictures of his removed meshes and I can honestly say that I have not seen any other pictures on the internet from surgeons that equal his calibre.