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Pelvic organ prolapse

Instead of living with POP, live better without it.

What is prolapse?

Up to 50% of women will experience pelvic organ prolapse.1

Pelvic organ prolapse (POP) is the dropping of the pelvic organs caused by the loss of normal support of the vagina. It occurs when there is weakness or damage to the normal support of the pelvic floor causing pelvic organs (the vagina, cervix, uterus, bladder, urethra, intestines or rectum) to drop down. Women with POP may feel or see a bulge coming out of the opening of their vagina. 2

Experiencing pelvic organ prolapse can be challenging — it can interfere with your activities, intrude on your personal life, and cause some serious discomfort.2 However, there are effective solutions3 that can repair POP at the source, so you can get back to living the life you want.

Find your path to prolapse relief

No two people walk the same path to a diagnosis or solution. Every woman’s prolapse journey is different, and they may reach these steps at different paces and during different times in their lives.

Do I have prolapse?

Are the symptoms you’re experiencing more than just an inconvenience? Learn about the signs and causes of pelvic organ prolapse.

What is prolapse?
Causes of prolapse

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Selecting the right kind of doctor

The right doctor will listen to you and put your needs first. But how do you find them?
Finding the right provider

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What are my options?

It is important to understand your body and learn about all of your treatment options, both non-surgical and surgical, to help find a solution that is right for you.
Explore options

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Is a surgical procedure right for me?

Find out about stopping symptoms at the source.
Learn about your
surgical options

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Preparing for surgery

What to know leading up to your procedure, how to prepare and plan.
Getting ready

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What to expect after surgery

Find out more about post-op downtime and what to expect after heading home.
Healing and heading home

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Types of prolapse

There are several different types of pelvic organ prolapse, with different names depending on the organs involved.4

Female pelvic anatomy without prolapse

Anterior Vaginal Wall Prolapse (Cystocele)

occurs when there is a loss of support to the front wall of the vagina. The bladder drops down and may cause a bulge in the vaginal opening.

Posterior Wall Prolapse (Rectocele or Enterocele)

occurs when there is a loss of support to the back wall of the vagina. The rectum or intestines drops down and may cause a bulge in the vaginal opening.

Apical Prolapse (Vaginal vault or Uterine)

occurs when there is a loss of support to the uterus and the top part of the vagina after a hysterectomy. These types of prolapse are often associated with the loss of anterior or posterior vaginal wall support.
While you may have obvious symptoms of prolapse, only your doctor can confirm which type of prolapse you’re currently experiencing.

Female pelvic anatomy without prolapse

Female pelvic anatomy without prolapse
Female pelvic anatomy without prolapse. (Left) Cystocele prolapse (Right)

Symptoms of prolapse

While it is not life-threatening, women with prolapse experience symptoms that impact their day-to-day lives and keep them from experiencing moments to the fullest. But these symptoms won’t always seem obvious. As prolapse progresses, the symptoms may become more apparent and painful. If you are experiencing prolapse, you may feel:

  • Pressure in the pelvic region, vaginal discomfort, pain or bleeding4
  • Pulling or aching in the lower abdomen or pelvis, a bulge coming out of the vagina4
  • Pain or discomfort during sex5
  • Difficulty urinating or having a bowel movement4

Symptoms of prolapse

While it is not life-threatening, women with prolapse experience symptoms that impact their day-to-day lives and keep them from experiencing moments to the fullest. But these symptoms won’t always seem obvious. As prolapse progresses, the symptoms may become more apparent and painful. If you are experiencing prolapse, you may feel:

  • Pressure in the pelvic region, vaginal discomfort, pain or bleeding4
  • Pulling or aching in the lower abdomen or pelvis, a bulge coming out of the vagina4
  • Pain or discomfort during sex5
  • Difficulty urinating or having a bowel movement4

What causes prolapse?

Pelvic organ prolapse can drastically impact your lifestyle. Things that can cause the muscles in the pelvis to become stretched or weakened include:

  • Pregnancy and childbirth2
  • Genetics2
  • Smoking2
  • Pelvic Floor Injury2
  • Chronic constipation2
  • Chronic coughing2
  • Obesity2
  • Menopause2
  • Nerve and muscle diseases2

What causes prolapse?

Pelvic organ prolapse can drastically impact your lifestyle. Things that can cause the muscles in the pelvis to become stretched or weakened include:

  • Pregnancy and childbirth2
  • Genetics2
  • Smoking2
  • Pelvic Floor Injury2
  • Chronic constipation2
  • Chronic coughing2
  • Obesity2
  • Menopause2
  • Nerve and muscle diseases2

Understanding treatment options

There’s nothing simple about dealing with prolapse, but there are treatment options. Your physician may recommend some of these non-surgical options as a first step to relief:

  • Vaginal pessary: a removeable device placed in the vagina to support the pelvic floor and support the prolapsed organ. Your physician will fit and insert the pessary, which must be cleaned frequently and may have to be removed before intercourse.6
  • Kegels: an exercise you can do on your own or with the guidance of a pelvic floor therapist to help strengthen your pelvic floor muscles.7
  • Biofeedback therapy: a technique that uses different types of devices to give information on how well pelvic muscles are contracting. This information can help improve awareness and control of pelvic floor muscles.7

Non-surgical options may involve long-term treatment, ongoing maintenance and continued expenses, and may not address the underlying condition.

Non-surgical options aren’t the only approach.

You have the option of surgical solutions backed by over 15 years of experience and clinical data with firsthand testimonials from those who’ve undergone POP procedures and experienced successful outcomes.

The type of surgery you get depends on the type of prolapse you have. Not every solution is right for every person – treatment decisions must be unique to each individual’s medical history, symptoms and lifestyle.

Finding the right doctor who will recommend the right procedure based on your needs will help make sure you’re on the right path.

Learn more about prolapse procedures

What are the outcomes?

Women experiencing POP deserve a clinically proven and effective solution that lasts.
Prolapse repair procedures have effective outcomes.

0 %

of patients were “satisfied”
or “very satisfied”8

0 %

of patients stated they
would definitely “do it all over again” if they had the chance8

0 %

stated they “would definitely recommend to a friend”8

Patient spotlight

Laurie’s story

Laurie first heard the words “cystocele,” “rectocele” and “pelvic organ prolapse” before her symptoms started, during a regular annual exam with her gynecologist.

Where should you start?

 

Important safety information

Restorelle® M, L, XL, Y and Y Contour Polypropylene Mesh
Important Safety Information

Restorelle is a polypropylene mesh device intended to treat uterine or vaginal vault pelvic organ prolapse in women. Restorelle is surgically implanted through a small incision in the abdomen to act as a support to weak or damaged muscles of the uterus or vaginal vault (top of the vagina). Once implanted, the mesh is permanent and not intended to be removed.

Restorelle M, L, XL, Y and Y Contour is indicated for use as a bridging material for sacrocolposuspension/sacrocolpopexy (transabdominal placement via laparotomy, laparoscopic, or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Restorelle M, L, XL, Y and Y Contour is not for females who have the following conditions:

  • Pregnancy or desire for future pregnancy
  • Potential for further growth (e.g., adolescents)
  • Pre-existing local or systemic infection. Treat the infection with the appropriate antiseptics and/or antibiotics to eliminate the infection before placing the Restorelle M, L, XL, Y and Y Contour mesh
  • Taking blood thinning medications (anticoagulant therapy)
  • Any condition, including known or suspected pelvic pathology, which could compromise implant or implant placement
  • Sensitivity/allergy to polypropylene

Check with your Physician on the warnings, precautions and risks associated with the use of this mesh. The effectiveness of Restorelle Y Contour has not been validated by a prospective, randomized clinical trial. A thorough assessment of each patient should be made to determine the suitability of a synthetic mesh procedure.

Check with your physician on:

  • alternative prolapse treatments that may be appropriate
  • the reason for choosing a surgical mesh procedure
  • the postoperative risks and potential complications of transabdominal mesh surgery
  • the mesh to be implanted is a permanent implant
  • some complications associated with the implanted mesh may require additional surgery; repeat surgery may not resolve these complications
  • serious adverse tissue responses or infection may require removal of the mesh and complete removal of the mesh may not always be possible
  • individuals who have varying degrees of collagen laydown that may result in scarring

As with all surgical procedures, patients with certain underlying conditions may be more susceptible to postoperative bleeding, impaired blood supply, compromised/delayed healing, or other complications and adverse events.

The risks and benefits of using Restorelle M, L, XL, Y and Y Contour should be considered in patients with: • Age-related underlying conditions • Autoimmune disease • Coagulation disorder • Connective tissue disorder • Debilitated or immunocompromised state • Diabetes • Pelvic radiation therapy or chemotherapy • Physical characteristics (e.g., body mass index) • Smoking-related underlying conditions • Urinary tract anomalies.

Any future pregnancy could negate the benefits of this surgical procedure. Patients should report any bleeding, pain, abnormal vaginal discharge or sign of infection that occur at any time.

Adverse events are known to occur with transabdominal synthetic mesh procedures and implants. Adverse events following mesh implantation may be new onset (de novo), persistent, worsening, transient, or permanent.

Adverse events may include but are not limited to: • Abscess (acute or delayed) • Adhesion/scar formation • Allergy, hypersensitivity or other immune reaction • Bleeding, hemorrhage or hematoma • Bowel Related (Bowel obstruction, Constipation and/or defecatory dysfunction, Fecal incontinence and/or anal sphincter incompetence, temporary inability to pass food and waste through the intestine (ileus)) • Reopening of surgical incision (dehiscence) • Delayed wound healing • Extrusion, erosion or exposure of mesh into the vagina or other structures or organs • Formation of abnormal connection or passageway that forms between two structures in the body (fistula) • Infection • Inflammation (acute or chronic) • Local irritation • Mesh migration • Tissue death (necrosis) • Pain Related (new onset (de novo) and/or worsening painful intercourse (dyspareunia), Neuromuscular symptoms (acute or chronic), Pain (acute or chronic), Partner pain and/or discomfort during intercourse) • Perforation or injury of soft tissue (e.g., ligaments, muscles, nerves, vessels), structures, or organs (e.g., bowel, rectum, bladder, urethra, ureters, vagina) • Fluid buildup at site of surgery (seroma) • Suture erosion • Urinary Related (Bladder storage dysfunction (e.g., increased daytime frequency, urgency, nocturia, overactive bladder, urinary incontinence), Ureteral obstruction, Urinary tract infection, Voiding symptoms (e.g., painful urination (dysuria), urinary retention, incomplete emptying, straining, positional voiding, weak stream) • Vaginal Related (new onset (de novo) or worsening prolapse in untreated compartment, abnormal wound healing (granulation tissue formation), Palpable mesh (able to be felt by patient and/or partner), Recurrent prolapse, Sexual dysfunction, Vaginal discharge (abnormal), Vaginal scarring, tightening, rigidity, shortening and/or contracture.

The occurrence of adverse events may require one or more revision surgeries, including removal of the mesh. Complete removal of the mesh may not always be possible, and additional surgeries may not always fully correct the complications. There may be unresolved pain with or without mesh explantation.

This treatment is prescribed by your physician. Discuss the treatment options with your physician to understand the risks and benefits of the various options to determine if a transabdominal mesh procedure is right for you.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

PM-07280 / Feb 2024


Axis Tutoplast®
Important Safety Information

Axis Tutoplast® Processed Dermis is processed from donated human tissue. The US FDA regulates Axis Tutoplast Processed Dermis as a human cell and tissue product and restricts it to homologous use.

Homologous use means Axis Tutoplast Processed Dermis can be used by a qualified healthcare professional to repair, replace, reconstruct or supplement soft tissue. For your procedure this may include supplemental support and reinforcement of soft tissue, such as graft placement below the urethra (suburethral) in stress urinary incontinence
(SUI) procedures, and support and reinforcement of fascial structures (a type of connective tissue) in the pelvic floor in pelvic organ prolapse procedures. The implant is provided sterile.

WARNINGS
The same medical/surgical conditions or complications that apply to any surgical procedure may occur during or following implantation. Discuss the associated risks and potential complications of this procedure with your physician. As with any human tissue implant, the potential for transmission of infectious agents may exist. A small number of patients may experience localized immunological reactions to the implant. Successful treatment is dependent upon the patient’s host tissue response. In order for this procedure to be successful, Axis Tutoplast Processed Dermis will need to be integrated and remodeled with your own tissue.

PRECAUTIONS
Axis should only be used by a qualified physician familiar with the implant and the surgical procedure. Please let your doctor know if you are not feeling well since poor general health or any conditions such as limited blood supply, compromised healing, or an active infection should be considered before use.

Tutoplast is a registered trademark of Tutogen Medical GmbH.

PM-25857 05/2023

References:

  1. Barber, M. D., & Maher, C. (2013). Epidemiology and outcome assessment of pelvic organ prolapse. International urogynecology journal, 24(11), 1783–1790. https://doi.org/10.1007/s00192-013-2169-9
  2. (n.d.). Pelvic Organ Prolapse. Voices for PFD. Retrieved December 2, 2022 from https://www.voicesforpfd.org/pelvic-organ-prolapse/
  3. (n.d.). Pelvic Organ Prolapse: Surgery. Voices for PFD. https://www.voicesforpfd.org/pelvic-organ-prolapse/surgery/
  4. (n.d.). Pelvic Organ Prolapse: Symptoms and Types. Voices for PFD. https://www.voicesforpfd.org/pelvic-organ-prolapse/symptoms-types/
  5. Gupta, P., Payne, J., Killinger, K. A., Ehlert, M., Bartley, J., Gilleran, J., Boura, J. A., & Sirls, L. T. (2016). Analysis of changes in sexual function in women undergoing pelvic organ prolapse repair with abdominal or vaginal approaches. International urogynecology journal, 27(12), 1919–1924. https://doi.org/10.1007/s00192-016-3066-9
  6. (n.d.). Pessaries. Voices for PFD. https://www.voicesforpfd.org/about/pessaries/
  7. (n.d.). Physical Therapy. Voices for PFD. https://www.voicesforpfd.org/about/physical-therapy/
  8. Culligan, P. J., Lewis, C., Priestley, J., & Mushonga, N. (2020). Long-Term Outcomes of Robotic-Assisted Laparoscopic Sacrocolpopexy Using Lightweight Y-Mesh. Female pelvic medicine & reconstructive surgery, 26(3), 202–206. https://doi.org/10.1097/SPV.0000000000000788