Surgical solutions for prolapse

Restore your normal

prolapse can be repaired

It’s time to get proactive about your prolapse

Prolapse can be repaired rather than just managed. And following surgery many women ultimately realize, “I wish I would’ve done it sooner.” It’s time you choose a solution that treats the source of the problem, instead of masking its symptoms. It’s time to find lasting relief.

Reconstructive surgical solutions are effective in repairing POP at the source of the symptoms, so you can get back to living the life you want.

Different prolapse procedure types

There are two approaches to POP repair.
Your physician will recommend a procedure based on your type of prolapse and your medical history.

Through the vagina (Transvaginal)

This approach includes various types of procedures where a surgeon corrects your prolapse through your vagina using your own tissue or a biologic graft, called an allograft (colpopexy).¹

female-pelvic-anatomy-without-prolapse

cystocele prolapse

transvaginal-pop-approach

Through the abdomen (Transabdominal)

This approach corrects prolapse via incisions in the abdomen that allow surgeons to attach surgical mesh from the vagina to tissue at the sacrum (sacrocolpopexy). This procedure can be done using a surgical robot or laparoscopic instruments.¹

female-pelvic-anatomy-without-prolapse

vaginal vault prolapse

transabdominal pop approach

What to expect before,
during and after surgery

Before surgery

You will likely have a pre-op visit with your doctor and possibly with your anesthesiologist. This is the time to ask questions you may have about your surgery and post-operative care. Your surgeon will review your medical history and recent experiences. You will have to provide a list of all medication and supplements you take. They will inform you of the correct preparations you should take prior to your procedure and medically clear you for your surgery.

Some physicians might recommend a “bowel prep” for the day before your procedure (a laxative or an enema). And if you are going to have anesthetic, you’ll be instructed not to eat or drink anything a minimum of six hours before your surgery.²

During surgery

During the surgery, your surgeon will place the synthetic graft (mesh) through an incision in your abdomen. If your surgeon uses a biologic graft (allograft) they will place it through an incision in the vagina.

If a synthetic mesh is used, your body’s tissue will grow through the holes in the mesh and the mesh will slowly become part of your body. Biologic grafts are typically absorbed by your body within 6 to 9 months.³

After surgery and into recovery

Although every pelvic organ prolapse patient’s recovery process is different, there are general, recovery guidelines that apply to most pelvic floor procedures.¹

It is common to spend one to four days in the hospital, depending on the type of surgery performed (outpatient or a brief stay in hospital).
Physical strain, sexual intercourse, and heavy lifting should typically be avoided for six weeks after surgery.
Patients often can resume other normal activities after two weeks or at the physician’s discretion.

Your physician will provide you with a specific details about your recovery process, and they may have other recommendations based on your individual needs.

Follow your physician’s recovery directions carefully. Even though you may not be feeling much pain from your surgical procedure, your body needs time to heal properly from the surgery and allow the mesh material to incorporate within your body’s natural tissue.

Contact your physician immediately if you have any problems after your surgery. It’s important to tell them if you have excessive bleeding, pain, abnormal vaginal discharge or signs of infection occurring at any time during your recovery. Your physician will give you a more detailed list of possible adverse events that can happen. Continue with your annual and other routine check-ups and follow-up care.

What are the outcomes?

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

0 %

of patients were “satisfied” or “very satisfied”⁴

0 %

of patients stated they would definitely “do it all over again” if they had the chance⁴

0 %

stated they “would definitely recommend to a friend”⁴

mesh

Let’s talk about mesh

Pelvic mesh is a woven sheet of synthetic
material designed to support organs via surgery.⁵

In 2019, the US Food and Drug Administration (FDA) ordered the sale and distribution of a specific type of synthetic mesh (known as transvaginal mesh) to be stopped.⁶ Similarly, POP surgeries involving synthetic mesh are no longer performed through the vagina (transvaginally), rather they occur through the patient’s abdomen (transabdominally). Learn more about synthetic mesh on the FDA website.

For over 15 years, transabdominal mesh has shown to be safe for POP repairs, with low rates of complications.⁷ Transabdominal mesh was created specifically for women’s bodies and is composed of a very thin, lightweight mesh made from a soft synthetic material designed to feel more natural.

FAQs

Prolapse 101

What is pelvic organ prolapse?

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.⁸

POP

pelvic organ prolapse is also known as “POP”

What are the symptoms of pelvic organ prolapse?

While some women do experience symptoms related to pelvic organ prolapse, many others may not notice any symptoms at all. It may also be difficult to identify prolapse symptoms as they often progress very slowly and you may not notice changes until you become symptomatic.⁹

Symptoms will often depend on which type of prolapse you are experiencing and the specific organ that is descending. Some common prolapse symptoms include pressure or fullness in the pelvic area, backaches, painful intercourse, urinary problems and constipation.⁹

Learn more about common symptoms of prolapse.

How common is pelvic organ prolapse?

Up to 50% of women will experience pelvic organ prolapse.¹⁰

What are the different types of pelvic organ prolapse?

There are three categories and five types of pelvic organ prolapse.⁹

Anterior Vaginal Wall Prolapse or cystocele

Posterior Wall Prolapse includes rectocele or enterocele

Apical Prolapse includes vaginal vault or uterine prolapse

Find out more about each type of prolapse and their signs and symptoms here.

What causes pelvic organ prolapse?

Pelvic organ prolapse can develop when events or activities happen that lead to increased pressure on the pelvic floor. Pregnancy and childbirth are the most common causes of pelvic organ prolapse due to the increased stress placed on the pelvic floor muscles.⁸

However, menopause, genetics, lifestyle (smoking), chronic constipation, previous vaginal surgery, chronic coughing or straining, heavy lifting, obesity and many other factors are connected to pelvic organ prolapse.⁸

Learn more about the causes of POP here.

Prolapse surgical treatment options

Can pelvic organ prolapse be successfully treated?

Yes, pelvic organ prolapse can be treated successfully.¹¹

There are many different treatment options available for pelvic organ prolapse. It is important to discuss your individual situation with a pelvic floor specialist who will discuss what options may be appropriate for your specific situation.

What are the treatment options for pelvic organ prolapse?

There are both non-surgical and surgical treatment options. The non-surgical options may include lifestyle changes, Kegel exercises, or vaginal pessaries (a removable device).¹¹

Depending on the severity of your pelvic organ prolapse symptoms and general health, surgery may be recommended. Surgical treatments are designed to repair the prolapse and support the pelvic organs with a biologic graft or synthetic mesh.¹¹

There are different types of pelvic organ prolapse surgeries, so it is important to discuss your options with your physician in detail to ensure that you find a treatment option that is right for you.

Learn more about treatment options.

What is prolapse surgery?

Prolapse surgery is a surgical procedure that uses a biologic graft or a synthetic mesh, and suturing it into place to repair the prolapse. The goal is to help keep the pelvic organs supported and in the correct place. The procedure can be performed through small incisions in either the vagina or abdomen.¹¹

How long does it take to recover from prolapse surgery?

Every patient’s recovery time is different. It is generally recommended that physical strain, sexual intercourse and heavy lifting should be avoided for six weeks after surgery, but the patient may resume other normal activities after two weeks or at the surgeon’s discretion. However, each patient and surgery is different. Your doctor will be able to provide you with your own individual recovery plan.

What are the risks associated with prolapse surgery?

Every surgery carries some level of risk. Prolapse repair surgery may not be suitable for every patient, and a thorough discussion between you and your doctor will enable both of you to determine if this treatment is right for you.

This surgery is not suitable for patients with the following:

Pregnancy or desire for future pregnancy
Potential for further growth (e.g. adolescents)
Pre-existing local or systemic infection
Taking anticoagulant therapy
Any condition, including known or suspected pelvic pathology, which could compromise implant or implant placement
Sensitivity/allergy to polypropylene

Other potential complications include pain, bleeding, infection, injury to blood vessels or nerves, bladder, urethra or bowel injury during mesh placement—which may require additional surgery. Complications can be temporary or permanent. For a detailed list of the potential risks please see the Important Safety Information.

Ask your doctor for more information about potential risks and complications, as well as your specific treatment plan.

What type of doctor performs the surgery?

Typically, prolapse repairs are performed by urogynecologists, urologists, or gynecologists.

Learn more about finding the right doctor to fit your needs.

Prolapse surgical treatment cost and coverage

How much does this cost? Will insurance cover the prolapse procedure?

Most insurance plans, including Medicare, cover these procedures. Consult your insurance carrier to find out the specific criteria for coverage. The reimbursement specialist at your physician’s office may also be able to help you get answers.

So, what’s the next step?

For more information about pelvic
organ prolapse, download the brochure

download

For more details about surgical options using allografts, download the brochure

download

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