By Elizabeth Akincilar, MPT, Cofounder, PHRC Merrimack

 

In May 2015 a Delaware jury ordered Boston Scientific, a medical device company, to pay a woman $100 million for pain complications following vaginal mesh placement for treatment of pelvic organ prolapse. A few months prior to that a Texas woman was awarded $73 million for similar complications. Some think that these cases are just the tip of the iceberg because many more similar cases are pending. Many companies like Johnson & Johnson have pulled some of their mesh products from the market altogether, whereas others continue to offer them.

 

The Offender: Mesh

 

Utilization of graft, traditionally a piece of living tissue that is transplanted surgically, has been used in pelvic floor reconstruction for over a century. In the beginning, grafts used in surgery to treat incontinence and prolapse were associated with a fair amount of complications. Things started to change when general surgeons began using synthetic grafts, or mesh, for hernia repairs and began getting much better outcomes. It wasn’t long before pelvic surgeons recognized the opportunity to improve their surgical outcomes and began using similar mesh products for pelvic floor conditions.

 

Fast forward to 1998 when the tension-free vaginal tape (TVT) mid-urethral synthetic (MUS) sling was introduced. This was a serious game changer for pelvic surgeons. Not only did it become the current gold standard for treatment of stress urinary incontinence (SUI), but it paved the way for the US FDA approval of transvaginal mesh prolapse repair. In 2010 approximately 210,000 synthetic slings were placed in the USA.² Success rates were estimated at 51-99% for retropubic (behind the pubic bone) and transobturator (TOT) slings^4-6.

 

Because of the success of the MUS slings, medical device marketing teams recognized a HUGE opportunity. It has been estimated that the prevalence of pelvic organ prolapse in women over 60 was 41.1%!¹ Surgery for prolapse is performed twice as commonly as for continence surgery. That’s like 30 million potential patients!!! As you can imagine, transvaginal mesh ‘kits’ started coming out of the woodwork. CHA-CHING!!!!! In 2010 approximately 75,000 women underwent transvaginal mesh placement for POP.²

 

The Complaints

 

Unfortunately, using mesh in surgeries for both incontinence and pelvic organ prolapse had some serious repercussions.

 

One study reviewed the complication rates for mid-urethral synthetic (MUS) slings for urinary incontinence between 1995 and 2007, and reported 4.3 – 75.1%  for retropubic slings, and 10.5 -31.3% for transobturator (TOT) MUS. The retropubic approach had a higher occurrence for bladder injury versus the TOT approach which reported more groin pain. However, pelvic pain and pain with intercourse has been reported in up to 24% following MUS slings. Another major concern after MUS surgery is urinary function. Some women report severe difficulty or inability to urinate or urinary frequency after MUS surgery. Overall, voiding dysfunction rates are estimated to be between 2.8 and 38% following a retropubic sling and 0-15.6% with the TOT approach⁷.

 

Early on, the results of transvaginal mesh looked promising for the treatment of pelvic organ prolapse (POP) in a few short-term studies. They were introduced to reduce recurrence as well as improve durability. Many companies began to market ‘mesh kits’ to simplify their placement transvaginally. However, serious complications started to emerge. Now it’s thought that the studies were not rigorous enough and many of the complications surfaced after the duration of the trial protocols.  

 

The complications included mesh extrusion, also called erosion or exposure, as well as infection and pain. Mesh extrusion is when the mesh is exposed within the vaginal canal. The Society of Obstetrics and Gynecology of Canada reported a mesh erosion rate of 5-19%. Another study from the Society of Gynecologic Surgeons reported an erosion rate of synthetic mesh to be 10.3%. The symptoms of mesh erosion include vaginal discharge, vaginal pain, pain with intercourse, or pain experienced by the sexual partner. Pain with intercourse, or dyspareunia, has been reported at rates of up to 38% following transvaginal mesh placement⁸. Mesh actually causing infectious complications is relatively rare.

 

The Contributing Factors

 

It is unclear exactly what the contributing factors are of these devastating complications. Some ideas include poor surgical technique, deficient training, infection, patient factors, or an inherent defect of the synthetic material. In addition, there are still lots of unanswered questions regarding vaginal tissue, the aging process and how the mesh affects the vaginal wall healing and inflammatory responses. Other potential risk factors include concomitant hysterectomy, advanced patient age, smoking and diabetes mellitus.

 

What actually leads to the pain after mesh placement is likely multifactorial. It is thought to be a combination of nerve or muscle damage/entrapment and/or tension on the vagina or surrounding structures as a result of retraction (shortening) of the mesh, scarring, or chronic inflammatory response to the mesh.

 

The FDA’s response

 

Some of these complications were found to be irreversible and debilitating which lead to two FDA notifications in 2008 and 2011. In 2008 the FDA released a Public Health Notification in response to the complications related to surgical mesh. In 2011 the FDA Safety Communication stated that the complications ‘are NOT rare’ and the ‘transvaginally placed mesh in POP repairs does NOT conclusively improve clinical outcomes over traditional non-mesh repairs’. Their aim was to educate the public and healthcare providers about mesh and provide recommendations for informed decision-making. In fact, the FDA published a list of questions patients were encouraged to ask their surgeons prior to undergoing vaginal mesh placement as well as recommendations following surgery. Here’s a few examples of the pre and post mesh placement questions recommended by the FDA. You can find the complete list of the recommended questions.

 

Recommended preoperative questions:

 

1. Why do you think I am a good candidate for surgical mesh?
2. What are the pros and cons of mesh in my particular case?
3. How likely is it that my repair could be successfully performed without surgical mesh?
4. If surgical mesh is to be used, how often have you implanted this particular product? What results have your other patients had with this product?
5. What can I expect to feel after surgery and for how long?
6. If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?

 

Recommendations for postoperative care:

 

1. Notify healthcare provider if you have any of the following:
   1. Persistent vaginal bleeding or discharge
   2. Pelvic or groin pain
   3. Pain with sex
2. Post-operative pelvic floor physical and occupational therapy
   1. Many women with pelvic organ prolapse can benefit from pelvic floor physical and occupational therapy to improve their musculoskeletal function, decrease certain pains, and help restore  normal bladder, bowel, and sexual function. Often times, pre and post-operative physical and occupational therapy is not offer to patients and it should be. Click for more information.

 

 

Treatment Options

 

For complications with a MUS sling in some women, either complete or partial removal of the sling is the only effective treatment. Removing the sling can be challenging for the surgeon and the extent of tissue damage is often unknown. Other possible treatment strategies include pelvic floor physical and occupational therapy, pain medications, and nerve blocks.

 

In women experiencing vaginal mesh exposure, treatment options include observation, use of topical estrogen or antiseptics, systemic or topical antibiotics, office-based trimming of the extruded material, and partial mesh excision or total mesh excision. Medical management alone with antibiotics, antiseptics and topical estrogen yield low success rates. Office-based mesh excision can be challenging due to limited visualization and discomfort for the patient. A more formal mesh excision, often a total excision, is preferred.

 

One study looked at 481 patients who underwent vaginal mesh revision. After mesh excision/revision surgery, 73% reported an improvement in pain, 19% experienced no change in pain, and 8% reported an increase in pain. Patients with prior chronic pelvic pain were significantly less likely to experience improvement in pain symptoms.³

 

Mesh excision has possible complications of its own. If the mesh was placed closer to the front of the vagina, excising it can injure the bladder or urethra. If the mesh was placed towards the back of the vagina, removing it could cause damage to the bowel.

 

The Mesh Hunter

 

Gynecologist and pelvic surgeon, Mark Conway, MD, commonly surgically excises vaginal mesh for women experiencing pelvic pain. During a brief interview, he gave us his two cents on mesh. Full disclosure, he has served as a plaintiff’s expert witness on mesh liability cases.

 

How do you determine who is a good candidate for surgical mesh removal?

Essentially, any patient with mesh that has pain is a potential candidate for surgical excision. However, an examination is essential. Upon vaginal exam, if palpation of the mesh causes pain, especially if it reproduces the pain the patient is complaining of, that is a good indicator that removing it would likely decrease or eliminate the pain.

 

How many surgical mesh removals have you performed?

200-300

 

What are the greatest challenges in surgically removing mesh?

It is easier to remove a completely intact mesh versus one that has been previously surgically revised. The transobturator mesh is more difficult to remove because the material is much more difficult to get to. Also concerning the TOT mesh, it can be very difficult to locate in the groin.  Another challenge is removing mesh that goes through the sacrospinous ligament, as is used in some repairs for pelvic organ prolapse. Lastly, mesh can get fibrotic and adherent, essentially stuck, to the bladder, urethra and bowel, which can be challenging to remove.

 

What are the greatest risks involved in mesh excision?

Bleeding can be a risk because the area is so vascular. Also wound infection and damage to the urethra, bladder and/or bowel are also risks.

 

How often have your patients already undergone a surgical mesh removal before consulting you?

80% of the patients that come to see me have already undergone at least one surgical mesh revision, and often they are on their 3rd or 4th procedure. In fact, patients are often told that their mesh had already been removed or can’t be removed any further, yet I am almost always able to find and remove additional mesh.

 

Do you utilize mesh in SUI and/or POP treatment?

I do not utilize transvaginal mesh for POP. I only perform a laparoscopic approach. I don’t place midurethral slings, but I will refer patients to a urologist to have it done.

 

Although surgeons and clinicians are recommended to report mesh and device complications, adverse events are underreported and the reporting process can be time consuming and is completely voluntary. Until a national registry exists, recognition of device-associated complications will be further delayed and not reported in the literature, thus exposing even more patients to these risks. Until then, I encourage women to do their homework before considering a mesh placement procedure. Find a surgeon who has performed many of these procedures and utilize the FDA’s recommended list of questions before you commit to surgery.

 

 

1. Hendrix SL, Clark A, Nygaard I, Aragaki A, Barnabei V, McTiernan A. Pelvic organ prolapse in the Women’s Health Initiative: gravity and gravidity. Am J Obstet Gynecol. 2002;186(6):1160–1166
2. US Food and DRug Administration (2011) FDA safety communication: update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse 13 May 2013.
3. Danford JM et al. Postoperative pain outcomes after transvaginal mesh revision. Int Urogynecol J (2015) 26:65-69.
4. Serati M, Ghezzi F, Cattoni E, et al. Tension-free vaginal tape for the treatment of urodynamic stress incontinence: efficacy and adverse effects at 10-year follow up. Eur Urol 2012;61(5):939-46 17.
5. Ward K, Hilton P; Group UaITT. A prospective multicenter randomized trial of tension-free vaginal tape and colposuspension for primary urodynamic stress incontinence: two-year follow-up. Am J Obstet Gynecol 2004;190:324-31 •• First randomized controlled trial between TVT and Burch colposuspension. .
6. Ogah J, Cody J, Rogerson L. Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev 2009;4:CD006375 19. B
7. Kasturi S, Hale DS. “J” cut of sling for postoperative voiding dysfunction following synthetic midurethral slings. Int Urogynecol J 2011;22(8):933-6
8. Bako A, Dhar R. Review of synthetic mesh-related complications in pelvic floor reconstructive surgery. Int Urogynecol J Pelvic Floor Dysfunct 2009;20(1):103-11

 

 

What is GYROTONIC®?
When I first heard a colleague talk about gyrotonic about 4 years ago, I was like “GYRO WHAT? To me it sounded like some form of geriatric exercise, so I asked her more about this type of exercise and she gave me the low down. ‘Gyro’ in greek actually means spiral or circle, and tonic means tone or invigorate. I then decided to sign up for some classes to check it out. I walked into a studio in Boston and to my surprise, I stumbled upon a small room with about 7 of these large pieces of equipment. All of the gyrotonic towers were intriguing to me, as they are handcrafted, and each one looks like a unique, wooden masterpiece. Growing up, I was a competitive swimmer and ended my career in college. I was always looking for an exercise similar to swimming where I would not have to jump in a freezing cold pool and expose myself to chlorine. When I started my first session with gyrotonic, I knew I had to become a certified instructor. Not only was I so happy to have found a fluid and rhythmical movement that reminded me of swimming, but I also really enjoyed having a one-on-one session where my super knowledgeable instructor had all eyes on me. If I did something wrong or engaged a muscle incorrectly, she was able to modify the exercise for me. I was coming back from a right hip injury, and gyrotonic was the best way I could have eased back into safe exercising because of the personalized treatment.

 

**Photo taken at GYROTONIC® Boston Central

 

EVERYONE is familiar with pilates and its popularity in the exercise world, however not many people are familiar with gyrotonic. As a gyrotonic instructor, I am often asked the question “What is gyrotonic?” and “How does it differ from pilates?” Gyrotonic is a unique movement method that incorporates simultaneous lengthening and strengthening of muscles. It helps to stimulate circulation and improve joint mobility and coordination. Gyrotonic exercise includes spiraling, circular movements, and more rhythmical movements, making it feel more like dancing, swimming, yoga, and Tai Chi. Most conventional strengthening regimens are more linear or isolated movements that do not include functional everyday movements. As humans, we do not move in a single plane, so it is important to do strengthening and exercise in more of a circular plane in order for it to carry over to activities of daily living. The whole idea of gyrotonic is to strengthen/stabilize muscles while lengthening the muscles and allowing the joint to move through a natural range of motion without compressing the joint.

 

Finally, special attention is focused on spinal motions to increase mobility and stability of the spine and pelvis. We, myself included, are so used to sitting all day long, whether it be in the car or at work. With prolonged sitting, we lose the mobility in our spines. This rigidity in our spines can cause a forward head and rounded shoulder position, and in turn can displace the center of gravity, and cause the pelvis to work extra hard to maintain an upright position.

 

Specialized Equipment: The gyrotonic expansion system is a pulley tower that provides smooth, even support and resistance. There is also an adjustable bench and rotating handle unit that can be adjusted to fit individual body types. The gyrotonic tower supports the natural range of motion of joints and allows for functional three dimensional movement.

 

 

GYROTONIC® and persistent pain: It is often difficult finding a form of exercise that allows movement and release of endorphins, especially when you are experiencing pain. Gyrotonic is a specifically gentle form of exercise similar to yoga, however, the equipment allows you to take away some of the effects of gravity and allows you to experience less impact. The equipment also adapts to your body so that you can be as comfortable as possible doing the gentle motions.

 

Exercises: Here are some basic exercises that incorporate the gyrotonic principles without use of the gyrotonic expansion system. These are simple exercises to do while at your work desk and will help to improve sitting posture. Take note that these exercises should be done without any pain. If you experience any pain, please stop the exercise.

 

Step 1 – Finding your sit bones:

This simple exercise is REALLY important in order to find a “balanced” or more upright sitting posture. Sitting in a firm chair, make sure you have your feet supported by the floor about hip distance apart. Take your hands and place your palms face up underneath the bony part of your bottom. As you do this, see if you are shifting your weight to one side more than the other. You should feel equal pressure in both of your hands. If you are leaning to one side, shift your weight and find that nice balanced position.

Upright Seated Posture                        Poor Seated Posture

 

Step 2 – Seated Figure 8:

This is a great exercise for releasing tension in the pelvis/hips/low back. This aids as a gentle hip/back stretch by incorporating sitting posture and balance. It also helps to improve postural support and balance, which is SO important when sitting at a desk all day. Start by finding your sit bones and feel your feet grounded on the floor about hips distance apart. Maintaining a neutral spine, start by shifting your torso forward so that you have more weight on the front of your sit bones/thighs. Then, shift your weight over to your right sit bone and then back onto your right posterior sit bone or your right buttocks muscle. Next, allow your weight to come forward through the center and then repeat on the left side. You want to think of making a circle around each sit bone so that it makes a figure 8 shape. Here is a video to better help guide the exercise.

 

Step 3 – Spinal Motions on Chair: This exercise helps improve mobility in the spine.
Arch/Curl: Maintaining a seated position like the above exercises, lift your chest toward the ceiling and open your palms so that they face forward. Come back to neutral and then go into the curl. Curl: Tuck your chin and curl your upper back and lower. Try to maintain an elongated spine reaching through the top of your head. Try to prevent too much hunching or collapsing by vacuuming your lower belly towards your spine in order to prevent any compression in your spine. Repeat this arch and curl motion 5 times.

  

Seated Arch                                           Seated Curl

 

Side Arch: Start in a neutral spine with arms by your side. Slowly, side bend your torso to the left, keeping your palms facing forward. Do not compress your left side, instead think of the left side bending but also elongating and maintaining space in the left hip. Come back to neutral and repeat on the right side. Perform this exercise 5 times on each side.

  

Right Side Arch                                      Left Side Arch

 

Spiral (rotation): start in a neutral spine and rotate body to the left. An emphasis of the rotation should be placed through the rib cage. Come back to neutral and then switch sides, rotating to the right side. Repeat exercise 5 times on each side.

  

Right Spiral                                              Left Spiral

 

Wave: Start in a neutral spine position and spread feet a little further than hip distance. Lift spine into arch position and then slowly bend forward at the hips. Once you get closer to your thighs, start to tuck your tailbone and curl your low back. Think of the curl starting from the lowest part of your back and then ending with a tuck of the chin. This should create a wave-like appearance and it feels wonderful!

 

Want to give it a try? Here is how to find a gyrotonic studio near you!

Find a gyrotonic studio near you!

Help!!! My pants are on FIRE!! Wait, what? Well, at least that’s what it feels like to a lot of people with pelvic pain. Because nerve pain can feel just like that – burning, tingling, like fire ants in your pants. In this post we are going to talk about how mediation can help.

 

Why is this sensation so common in people with pelvic pain? Let’s circle back to our old friend, the pudendal nerve. The pudendal nerve is special. It has nerve fibers that control how the muscles move, it regulates incoming skin sensations AND it has fibers that are linked to the fight or flight nervous system, a.k.a. the sympathetic nervous system.¹

Heart pounding, breath racing and blood pressure spiking are all signs of an activated sympathetic nervous system.

Fight or flight mode is on. It’s not always a bad thing to be in fight or flight mode. It has helped us survive over the centuries,but sometimes it gets turned on and stays on,that’s when it becomes a problem. And the pudendal nerve can get triggered via a mechanical problem, such as an overuse injury, surgery, compression, etc.,² but it can also get triggered when we are in constant fight or flight mode. (For more information on the pudendal nerve, please click here for our collection of archives on the topic).

 

Luckily we have an “antidote” to the sympathetic nervous system, its calming counterpart,the parasympathetic nervous system. It is the lesser known but equally as important,rest and digest part of the nervous system. Deep breathing, decreased heart rate and increased digestion are all signs the parasympathetic nervous system is in control.³ One way to activate the parasympathetic nervous system is through meditation.

 

Whether you are chanting the same word over and over again or being guided through a body relaxation, most styles of meditation have the same central focus – being present and deep breathing. Across gender, race and age, meditation is a research proven way to decrease the dominance of your fight or flight nervous system. One study showed that mindful meditation significantly reduced blood pressure, sympathetic nerve activity and heart rate, compared to the control group, in African-American males with kidney disease.⁵ Another study demonstrated that guided meditation significantly reduced heart rate, sympathetic reactivity and cortisol levels, compared to the control groups, in healthy adult males who were brand new to meditation.⁶ Even people that have never practiced meditation before can benefit from its positive effects. Meditation is a real, studied and effective way to reduce stress.

 

The verdict is still out on exactly HOW meditation really taps into the rest and digest nervous system, but one factor that contributes to the relaxation response of meditation is slow, deep breathing. Research shows that when we inhale AND when we breathe slowly, the fight or flight nervous system is inhibited.⁷ Slow, deep breathing is under the control of the rest and digest nervous system. Just ten minutes of slow, deep breathing significantly lowered blood pressure, heart rate and respiratory rate in people with hypertension.⁸ Breathing slowly will make you relax. So simple!

 

Let’s put this all together now. The pudendal nerve has branches of the fight or flight nervous system. Meditation decreases stress and sympathetic activation. Deep breathing inhibits the fight or flight system AND kicks in the rest and digest nervous system. When your pelvic floor is acting up, it will literally help to take a deep breath and meditate. Even though it might be the last thing you want to do when you’re in pain,you can help put out the fire in your pants by slowing down, breathing deeply and taking some time to meditate. It’s not “just in your head,” it’s in your nervous system.

 

Stop. Don’t Panic. Breathe. Meditate. Not sure how? There’s an app for that (insert eye roll). But seriously, there are several that we recommend here at PHRC, but our top FREE choices are Calm and Headspace. Give it a try and let us know what you think!

 

1. Pelvic Pain Explained by Stephanie A. Prendergast & Elizabeth H. Rummer
2. Cortisol as a Marker of Stress by A. I. Kozlov and M.A. Kozlova
3. The Pelvic Floor by Beate Carriere and Cynthia Markel Feldt
4. http://medical-dictionary.thefreedictionary.com/parasympathetic
5. Mindfulness meditation lowers muscle sympathetic nerve activity and blood pressure in African-American males with chronic kidney disease by Jeanie Park, Robert H. Lyles, and Susan Bauer-Wu
6. Effect of Meditation on Stress-Induced Changes in Cognitive Functions by Amit Mohan, MD, Ratna Sharma, PhD, and Ramesh L. Bijlani, MD, SM
7. Self-Regulation of Breathing as a Primary Treatment for Anxiety by Ravinder Jerath, Vernon A. Barnes, Kyler Harden
8. Effects of mental relaxation and slow breathing in essential hypertension by Rajeev M. Kaushik, Reshma Kaushik, Sukhdev K. Mahajan, and Vemreddi Rajesh