“As Urogynecologic/Female Pelvic Medicine and Reconstructive Surgeons, our armamentarium to repair the female pelvic floor has been significantly impacted by the recent removal from the market of synthetic mesh kits used for transvaginal repairs. As such, surgeons have searched for other options in order to achieve high success rates for prolapse repairs. Early results with the EnPlace system, during a postmarket clinical study, are encouraging as a minimally invasive, mesh-free and dissection free approach for pelvic floor procedures. The EnPlace system could be an excellent component (for those women who do not want or have tried a pessary) for the patient who desires a rapid and less restrictive recovery, or who cannot tolerate a prolonged procedure. We will continue to follow our patients, however  EnPlace is becoming an important part of our POP treatment algorithm.”

G. Willy Davila, M.D. F.A.C.O.G.
Urogynecology/Reconstructive Pelvic Surgery Medical Director,
Women & Children’s Services at Holy Cross Medical Group Ft. Lauderdale, FL

There has been an escalating and spirited debate regarding the use of transvaginal mesh for pelvic organ prolapse (POP) reconstructive surgery.
The following synopsis provides a brief clinical history an background, to help explain the current landscape and important new (mesh-free) technology in the Women’s Pelvic Floor Health arena.

Data from three trials[2-4] compared native tissue repairs with a variety of total, anterior, or posterior polypropylene vaginal mesh kits for pelvic organ prolapse in multiple compartments. While no difference in awareness of prolapse was identifiable between the groups (RR 1.3, 95% CI 0.6 to 1.7) the recurrence rate on examination was higher in the native tissue repair group compared to the transvaginal polypropylene mesh group (RR 2.0, 95% CI 1.3 to 3.1). The mesh erosion rate was 35/194 (18%), and 18/194 (9%) underwent surgical correction for mesh erosion. Assuming all the patients that underwent mesh erosion correction were the patients diagnosed with mesh erosion – these trials show that half of the patients who were diagnosed with mesh erosion required repeat surgery to resolve the situation. The reoperation rate after transvaginal polypropylene mesh repair of 22/194 (11%) was higher than after the native tissue repair (7/189, 3.7%) (RR 3.1, 95% CI 1.3 to 7.3).

In early 2016, the FDA increased its scrutiny into vaginal mesh implants and reclassified surgical mesh for transvaginal repair of pelvic organ prolapse as Class III, requiring submission of premarket approval (PMA) applications, the agency’s most stringent device review pathway. (Device classification depends on the intended use and indication of the device. Any potential risk from the device is a factor in class designation.  Class I devices are low risk and Class III devices are greater risk.)

Also in 2016, a meta-analysis by Maher et al[6] was published in the Cochrane review. The paper reviewed 37 randomized control trials (RCTs) which represented n = 4,023 women. The authors concluded that, “While transvaginal permanent mesh is associated with lower rates of awareness of prolapse, repeat surgery for prolapse, and prolapse on examination than native tissue repair, it is also associated with higher rates of repeat surgery for prolapse or stress urinary incontinence or mesh exposure (as a composite outcome), and with higher rates of bladder injury at surgery and de novo stress urinary incontinence. The risk‐benefit profile means that transvaginal mesh has limited utility in primary surgery. While it is possible that in women with higher risk of recurrence the benefits may outweigh the risks, there is currently no evidence to support this position.[6]”

The concern over pelvic floor mesh gathered global momentum. In November 2017, the Australian Therapeutic Goods Administration (TGA) completed an extensive clinical review and concluded that the risks of pelvic floor mesh outweighed the potential benefits and removed the products for sale in Australia. Similarly, in December 2017, the United Kingdom’s National Institute for Health and Care Excellence (NICE) guidelines were published, recommending that mesh should no longer be used to treat prolapse in the UK. By July 2018, pelvic floor mesh was no longer available in the UK. This growing trend to eliminate products such as mesh, heavily impacts the millions of women (globally) who may benefit from pelvic floor treatment.

On April 16, 2019[7], the FDA ordered all manufacturers of transvaginal surgical mesh (for repair of anterior compartment prolapse (cystocele)) to immediately stop selling and distributing their products. The FDA determined that the manufacturers have not demonstrated reasonable assurance of safety and effectiveness for these devices.

In 2013, POP Medical Solutions, Ltd. began product development and conducted extensive cadaveric and engineering labs to answer the question, “Could pelvic ligament fixation be conducted with a small, single-incision, no mesh implant and no dissection?” That early development created the “NeuGuide” platform and a unique, novel surgical instrument was born. After preclinical cadaveric and animal trials showed promising results, a First-In-Woman (“FIW”) study was performed in Israel (n = 15), including post-hysterectomy patients (n = 6), which is a difficult population to treat. By 2016, the NeuGuide system received FDA clearance and, in 2018, after receiving CE Mark, a 15-site, global Post-Marketing Study was initiated to measure the results of this novel approach for pelvic floor ligament fixation[10]. In 2019, the company changed its name to FEMSelect, Ltd.

FEMSelect now introduces the revolutionary new system to provide Female Pelvic Medicine and Reconstructive Surgeons with an option for truly minimally invasive pelvic floor ligament fixation: The FEMSelect EnPlace.

The EnPlace system is a meshless, truly minimally invasive anchoring device for attaching sutures to the sacrospinous ligaments with a small incision and no deep dissection. By utilizing a patented Finger Guide, which also provides a direct working channel for the surgeon –anchor placement can be both quick and precise. Since the working channel is part of the Finger Guide, the surgeon can rely on delivering an anchor to an exact location, every time.

Several studies were performed to validate and test the efficacy and durability of the EnPlace system (formerly called the “NeuGuide”).

In a preclinical study,[8] the pull-out force of the device was tested by performing measurements both on a porcine model and human cadavers. In the porcine model the mean pull-out force was 34.13±4.32 N. None of the measured forces were below 20 N (1 N is the force applied by 100 grams of weight to a surface it is placed upon), 35.68±9.28 N and none of the measured forces was below 20 N. No statistically significant difference was noted between the pull-out forces in the porcine and the cadavers (p=0.60).

Results of the first 10 patients of the FIW study were published (Weintraub, et al 2017)[9] confirming EnPlace safety and efficacy. There was no injury to the bladder, rectum, pudendal nerves, or significant pelvic vessels and no febrile morbidity was recorded. At six months, results included 0/10 cases of centro-apical recurrence. Patients remain satisfied with the procedure and had favorable quality of life scores. The UDI-6 questionnaire (Urogenital Distress Inventory assesses symptom distress and quality of life in women suffering from urinary incontinence) was used to assess the quality of life of the patients and showed improvement in all domains. (Figure 2) Although the sample size was small, the improvement in urge and overflow incontinence related domains were demonstrated to be statistically significant.

The initial 15 “FIW” patients are now out, nearly four- ears. The FIW investigators are diligently examining the follow-up data, intending to submit and publish the findings in a Peer Review setting. The “FIW” patients represent an important series to show the durability of the EnPlace fixation platform.

The 15-center, global Post-Market Approval study began in February 2018 – measuring success with 30 patients who required treatment for only uterine prolapse, to measure that the EnPlace system provides an acceptable approach for pelvic floor ligament fixation. Six-month data on the initial patients is very encouraging and the initial abstract was accepted for presentation to the combined AUGS/IUGA (American and International Urogynecologic associations) conference (September 2019). As the initial phase of the Post-Market study (n = 35) was completed, a second phase was developed to address more real-world patients who present with multiple pelvic floor symptoms and potentially requiring concomitant procedures for anterior/posterior repair or a mid-urethral sling for stress urinary incontinence. Coincidentally, the second phase of the study began approximately six-weeks before the FDA’s ruling to remove transvaginal mesh from the market. The expanded protocol allowed access to a larger patient population and subsequently, the second arm of the study (n = 30) will complete enrollment by August 2019.

The options for treatment of Pelvic Organ Prolapse have changed dramatically since 2011. The recent FDA ruling to remove transvaginal mesh from the Women’s Health arena is a significant change for both physicians and patients and yet, few options remain to help the millions of women who require treatment for this debilitating and often, painful condition.

The FEMSelect EnPlace stems from years of Urogynecologist-based development and provides a minimally invasive option for ligament fixation.  The EnPlace™ is rapidly being evaluated as a potential leading option in the Women’s Health arena.

1. Maher, C., et al., Surgical management of pelvic organ prolapse in women. Cochrane Database of Systematic Reviews, 2013. 2013(4).
2. Withagen, M.I., et al., Trocar-guided mesh compared with conventional vaginal repair in recurrent prolapse: a randomized controlled trial. Obstet Gynecol, 2011. 117(2 Pt 1): p. 242-50.
3. Iglesia, C.B., et al., Vaginal mesh for prolapse: a randomized controlled trial. Obstet Gynecol, 2010. 116(2 Pt 1): p. 293-303.
4. Halaska, M., et al., A multicenter, randomized, prospective, controlled study comparing sacrospinous fixation and transvaginal mesh in the treatment of posthysterectomy vaginal vault prolapse. Am J Obstet Gynecol, 2012. 207(4): p. 301 e1-7.
5. Maher, C., et al., Surgery for women with anterior compartment prolapse. The Cochrane database of systematic reviews, 2016. 11: p. CD004014.
6. Maher, C., et al., Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. The Cochrane database of systematic
   reviews, 2016. 2(2): p. CD012079-CD012079.
7. FDA, Urogynecologic Surgical Mesh Implants, https://www.fda.gov/medical- vices/implants-and-prosthetics/urogynecologic-surgical-meshimplants.
8. Tsivian, M., et al., Introducing a true minimally invasive meshless and dissectionless anchoring system for pelvic organ prolapse repair. Int Urogynecol J, 2016. 27(4): p. 601-6.
9. Weintraub, A.Y., et al., Safety and short term outcomes of a new truly minimally invasive meshless and dissection-less anchoring system for pelvic organ prolapse apical repair. Int Braz J Urol, 2017. 43(3): p. 533-539.
10. https://www.clinicaltrials.gov/ct2/show/NCT03436979?term=neuguide&rank=

Answers about pessary use to relieve symptoms of pelvic organ prolapse

Millions of women around the world have pelvic organ prolapse. However, the number of women who are talking about it is much less! That’s likely the reason why there is so much confusion and so little understanding about the various treatments for this common disorder.

While prolapse is not life-threatening, that doesn’t mean any woman should simply suffer with the discomfort and reduced quality of life that it can cause. One method to help relieve your symptoms is a pessary, which may provide temporary support of prolapse or pelvic floor organs.

Because pessaries don’t get a lot of press (and most women are hesitant to boldly introduce the topic over a cup of coffee), we’ve prepared the following questions and answers to address your concerns.

What exactly is a pessary?

A pessary is a soft, removable prosthetic device that is custom-fitted and inserted into the vagina during a standard office visit to your doctor, often a urogynecologist. After insertion, the pessary supports the areas of your pelvis that have been affected by prolapse.

Pessaries are latex-free, come in various shapes and sizes, and are safe to use. Your doctor will determine which type to use to help with your specific degree or type of prolapse. After a short training session, most women can competently remove the pessary and reinsert it by themselves.

Is a pessary the primary option for supporting prolapse?

The most suitable option for supporting prolapse depends largely on the level of discomfort and severity of the prolapse. Using a pessary is one way to experience relief. Other ways to cope include:

• If it isn’t too bothersome, many women choose to do nothing.
• For mild cases of prolapse with manageable symptoms, helpful therapies include pelvic floor muscle exercises, dietary changes, and physical therapy.
• If the prolapse is more disruptive, traditional options include wearing a pessary or having surgery.

A new device for use in vaginal surgery  is EnPlace™, an innovative and minimally invasive approach for pelvic floor ligament fixation, which recently received FDA clearance for pelvic floor ligament fixation. In comparison to a pessary, EnPlace™ offers a more permanent way to support prolapse.(Learn more about EnPlace at femselect.com)

What are the different kinds of pessaries?

The two main types of pessaries are categorized as support and space-filling. Both kinds are usually made from medical-grade silicone, which is highly durable and nonabsorbent. The frequency of when your pessary must be changed or replaced depends on the type, and your doctor will provide personalized instructions.

What is the fitting process?

It’s essential to stress that you must visit a trained and experienced medical professional to fit your pessary, because if it is fitted improperly – not only will it fail to improve your symptoms, but it can also cause vaginal damage.

What happens? First, a collapsed pessary is inserted into the vagina and placed just beneath the cervix. A few sizes and shapes may need to be tried before the perfect fit is found. Then, your doctor may inflate it using a bulb (depending on the type). Once it is snug in place, you should not notice it at all. Because the fitting and insertion process is not too uncomfortable, no anesthesia is usually required.

Before you head home, your doctor will teach you how to insert, remove and clean the pessary on your own. About a week later, you’ll need to return for a follow-up exam to confirm that the fit is still tight and healthy. Future check-ups will be needed throughout the next months, in addition to a comprehensive annual exam.

Can a pessary cure prolapse?

No. Unfortunately, a pessary is not a cure or repair for pelvic organ prolapse. However, it can alleviate your symptoms and enable you to return to enjoying your regular lifestyle – exercising, taking care of your family, and working normally, for example.

How long is a pessary worn for?

It depends on why you’re wearing it. A pessary can be worn temporarily until you have surgery to treat the prolapse, or it can be worn long-term if you don’t want (or cannot have) surgery. Keep in mind that while a pessary is a safe long-term treatment, it does need to be replaced every three to six months – either by yourself or by your doctor.

What are the advantages of using a pessary?

A pessary lifts your pelvic organs, thereby reducing the symptoms of prolapse. The benefits of this specific therapy include:

• It is less invasive than surgery
• It has significantly lower risks than surgery
• It is relatively inexpensive

What are the downsides of using a pessary?

Every medical treatment has its pros and cons. With pessaries, the most common possible side effects are: vaginal discharge – often foul-smelling, vaginal irritation, urinary tract infections, and stress-incontinence (leaking a small amount of urine during exercise or sneezing). Because pessaries are removable, these side effects can usually be resolved quickly upon consultation with your doctor.

While serious complications from a pessary are rare, many women become frustrated with these annoying side effects and they discontinue wearing it after about two years, on average.

Can a pessary be worn during sexual intercourse?

With most types of support pessaries, you can have intercourse with it in place – although some women prefer removing it. Note – a properly fitted pessary should not be felt by either partner.

Can a pessary fall out?

If it’s not fit correctly or if you strain excessively, a pessary can fall out. But no worries… it can’t end up anywhere else in your body or “get lost” inside you.

Is it hard to care for a pessary?

With clear instructions from your doctor, you should be able to remove, clean, and replace most types of pessaries efficiently by yourself–although some kinds may require a visit to your doctor every few months for cleaning. To clean the pessary at home, use mild soap and water and rinse it off well before reinserting it. This maintenance routine will need to be done either daily or weekly. To reduce the risk of vaginal irritation, your doctor may also prescribe an estrogen cream to apply while the pessary is out.

Interested in learning more about the available therapies to relieve the discomfort of pelvic organ prolapse? If you want to avoid invasive surgery and you’re uncertain whether using a pessary is right for you, consult your physician, and contact us for more information about EnPlace™ – a minimally invasive and mesh-free device for pelvic floor ligament fixation.

A healthy and well-functioning pelvic floor keeps the pelvic organs (bladder, uterus, vagina, small intestines, and rectum) in place. Sometimes, the pelvic floor weakens or becomes injured, causing what’s known as pelvic organ prolapse (POP), a condition in which the pelvic floor fails to sustain its function. The muscles that support the pelvic organs weaken, and a “prolapse” occurs — the organs sag into the vaginal canal or the anus and in some cases, the organs stop working.

The Association for Pelvic Organ Prolapse Support estimates that at least 50% of the world’s female population will experience pelvic organ prolapse (POP) at some point in their lives. Considering a female population of almost 4 billion in 2019, POP is definitely a pandemic requiring our attention. Women who experience the following have a higher risk of developing the POP:

• Vaginal Childbirth
• Obesity
• Advanced age
• Family history of POP
• Sustained pressure on the abdomen

POP affects a woman’s daily life so significantly that it requires immediate treatment. Treated on time, POP can be fully reversible, so it pays to be familiar with its symptoms and work out a plan with your doctor.

The Symptoms of POP

Voices for PFD, an organization that helps women with pelvic floor disorders, says some women have no symptoms at all. Others, however, may feel the following:

• Pressure or fullness in the pelvic area – Often, this sensation feels worse when you’re standing or coughing. And it grows worse as the day goes on. The pain subsides when you’re lying down but the prolapse is still there.
• Feeling something falling out of the vagina – In some cases, you might feel like you’re sitting on a ball or be forced to push the prolapse back in place to function.
• Backache – This may be a sign that the small intestine or the uterus has prolapsed.

• Painful intercourse – This might signal prolapse (enterocele, rectocele, cystocele or uterine prolapse).
• Urinary problems – These include leaking urine and a frequent urge to urinate. A woman may find it difficult starting the stream of urine or emptying the bladder. Sometimes, urine leaks during intercourse. These issues might indicate cystocele.
• Bowel movement problems – Some women need to push on the vagina to move their bowel. During intercourse, some experience leaking of stool. And in serious cases, women must place their fingers into or around the vagina in order to move the bowel.
• Constipation – A sign of rectal prolapse (rectocele).
• Bleeding or discharge from the vaginal opening – Exposed skin may bleed and leave a mark on pads and underwear.
• Problems inserting tampons – Since the organs are prolapsing, the tampons might not settle comfortably in the vaginal canal. In some cases, tampons can even be expelled out the vagina.
• A bulge of tissue at the vaginal opening – The prolapse could be so advanced that women can see a bulge at the opening of the vagina.

Treatment of POP

Currently, there are three types of remedies for POP. Bear in mind that the treatments depend on the severity of the symptoms.

1. Physical – Kegel exercises can strengthen the muscles of the pelvic floor.
2. Mechanical – Medical professionals can advocate the use of a pessary, a small device inserted into the vagina to support prolapsing organs. This should be fit and usage of it should be instructed by medical professionals.
3. Surgical – Surgery can repair or remove the prolapsing organ.  There are a variety of surgical options so this should be discussed with a medical professional.  POP  Medical has developed a minimally invasive surgical option. The EnPlace device and procedure is an innovative surgical system that involves no mesh implant and a minimal incision, so the recovery period – is short (only a few days).

When you’re at risk for POP, it’s best to have yourself checked by a physician, particularly a urogynecologist or urologist who specializes in treating pelvic floor symptoms.  Early diagnosis makes treatment easier and mitigates the damage that the condition can cause. Schedule a consultation with your physician if you notice these symptoms.

Contraindications

EnPlace Implant is NOT intended for use on the following:

Do not use the EnPlace device on patients undergoing anticoagulation therapy.

Do not use the EnPlace device on patients with an autoimmune disease affecting connective tissue.

Do not use the EnPlace device on patients under 18 years.

Do not use the EnPlace device on patients with pre-existing conditions that pose an unacceptable surgical risk.

Do not use the EnPlace device on patients with known Nickel or Ni / Ti allergy.

Do not use the EnPlace device on pregnant women or those considering future pregnancy.

A woman’s pelvic floor refers to the group of muscles and connective tissues that form a hammock across the pelvis and are responsible for holding the uterus, bowel, bladder, and vagina in-place so they can function properly. Sometimes, the pelvic floor muscles can weaken either spontaneously or due to an injury (frequently obstetric), which can lead to certain urinary, fecal or sexual disorders.

What is Pelvic Organ Prolapse?

One pelvic floor disorder (PFD) caused by significant pelvic floor weakness is pelvic organ prolapse (POP). When your pelvic muscles and tissues lose their ability to support one or more of your pelvic organs, the organs will press against or drop into and outside the vagina.

Different types of POP include:

• Uterine Prolapse. Uterine prolapse can cause the uterus and cervix to move down into the vagina and even come out of its opening.
• Vaginal Vault Prolapse. When the vaginal apex and walls lose support after a hysterectomy (surgical removal of the uterus), the vaginal vault can drop through the opening.
• Cystocele or Dropped Bladder. This most common type of POP occurs when the bladder falls into or out of the vagina.
• This occurs when the rectum swells into or out of the vagina.

What are the Common Risk Factors?

Vaginal childbirth is one of the most common risk factors for POP since the delivery process stretches and strains the pelvic floor. Multiple vaginal childbirths, babies weighing more than 8.5 pounds, vacuum or forceps’ delivery, and rapid labor, all increase the risk for POP.

While at lower risk, women who have never had children or had a cesarean or C-section delivery can also get prolapse.

Moreover, chances of getting POP increase as you age. In fact, PFD is more prevalent among older women, particularly those between the ages of 60 to 80.  In line with this, hormonal changes during and after the menopause period can trigger this disease.

Family history may also be a contributing factor to the development of POP.  A woman whose mother had a pelvic floor disorder is at risk for developing these disorders herself.

How Can You Reduce Your Risk? 

Some risk factors are beyond your control, such as aging, family history, or complicated vaginal delivery, however, there are ways in which you can minimize the possibilities of getting this disorder. Kegel exercises and other physiotherapeutic techniques are good ways to regain muscle strength in your pelvis and help balance the pelvic floor. While reverse Kegels can help relax and release the pelvic floor muscles, standard Kegels help contract and release the pelvic  .

Maintaining a healthy weight can also help lessen your risk for POP since it has been proven that women who are overweight or obese have a higher risk for POP.

A healthy diet also plays an important role in achieving a healthy body. Foods rich in fiber help prevent constipation and straining during bowel movements which exerts stress on the pelvic floor.

If you’re a smoker, quitting will also reduce your risk of POP since chronic cough often caused by smoking can put stress on the pelvic floor muscles.

When you experience any of these symptoms it is critical to seek medical advice, so it does not get worse.  There are treatments and creating a treatment plan early in the course of the disease will improve the outcome.