Patient Frequently Asked Questions

Note: Please consult your physician to discuss your questions and medical care.

Table of contents


Questions related to FDA Notification

Q: I heard the FDA issued a notification regarding synthetic vaginal mesh used for pelvic organ prolapse. I’m not sure if that was used in my pelvic organ prolapse procedure. What should I do?

For patients who have had vaginal mesh surgery for pelvic organ prolapse, are satisfied with their surgery and are not having complications or symptoms, there is no need to take any action other than routine check-ups and follow-up care. Patients with complications or symptoms after surgery should notify their health care provider. If you’re still concerned and not sure if your doctor used mesh feel free to call the health care provider who performed your procedure to get more information.

Q: I have had a procedure for pelvic organ prolapse and I am certain that synthetic vaginal mesh was placed. Can this be reversed? Should I have a procedure to correct it?

For patients who have had vaginal mesh surgery for pelvic organ prolapse, are satisfied with their surgery and are not having complications or symptoms, there is no need to take any action other than routine check-ups and follow-up care. Patients with complications or symptoms after surgery should notify their health care provider. Non-surgical treatment options that may help alleviate your symptoms. Depending on your symptoms, your health care provider may recommend that removal of the mesh is necessary.

Q: I was recently diagnosed with pelvic organ prolapse and my doctor mentioned synthetic vaginal mesh as a treatment option. What should I do?

Pelvic organ prolapse can be treated in several ways depending on the exact nature of the prolapse and its severity. You and your physician should review the benefits and risks of ALL potential treatment options. Treatment options include non-surgical options (i.e. diet, fitness routine, pessary and physical therapy), non-mesh surgery (i.e. native tissue or biologic graft vaginal repairs), abdominal or laparoscopic mesh procedures and transvaginal mesh placement. No one approach has proven to be superior in all cases. Your physician will discuss with you all your options and recommend the procedure that best meets your needs.

Q: I had a sling placed for urinary incontinence. Isn’t that a mesh? Should I be concerned?

The sling can be made of synthetic mesh material (polypropylene).


SUI Questions: Diagnosis

Source: https://www.mypelvichealth.org/FrequentlyAskedQuestions/Surgery/tabid/130/Default.aspx

Q: What are some of the symptoms of Stress Urinary Incontinence (SUI) ?

Stress urinary incontinence is the involuntary loss of urine during physical activity, which may include but is not limited to: coughing, laughing, or lifting.

Incontinence occurs when the muscles that support the urethra (the tube that carries urine out of the body) are weakened or damaged. This can happen as a result of childbirth, trauma, hormone changes and many other reasons. You don’t have to live like this. This type of incontinence can be treated both surgically or nonsurgically.SUI Conditions

Q: What type of stress urinary incontinence do I have?

One condition is called hypermobility, (“hyper” means too much and “mobility” refers to movement) which can result from childbirth, previous pelvic surgery or hormonal changes. Hypermobility occurs when the normal pelvic floor muscles can no longer provide the necessary support to the urethra. This may lead to the urethra dropping when any downward pressure is applied, resulting in involuntary leakage.

Another condition is called intrinsic sphincter deficiency, usually called ISD. This refers to the weakening of the urethral sphincter muscles or closing mechanism. As a result, the sphincter does not function normally regardless of the position of the bladder neck or urethra.

Remember, millions of women are going through exactly what you are going through. Seeing your physician and knowing your options are the first steps.

 


SUI Questions: Treatment Options

Source: https://www.mypelvichealth.org/FrequentlyAskedQuestions/Surgery/tabid/130/Default.aspx

Q: What are some treatment options?

Stress urinary incontinence can be treated in several ways, depending on the exact nature of the incontinence and its severity. You and your physician may discuss:


SUI: After Surgery

Source: https://www.mypelvichealth.org/FrequentlyAskedQuestions/Surgery/tabid/130/Default.aspx

Q: How will my surgery be performed?

Your minimally-invasive sling procedure is estimated to only take 30–45 minutes.SUI Sling Options

Your doctor will determine the type of anesthesia you will have during the procedure. Once the anesthesia takes effect, your doctor will begin the procedure. A small incision will be made in the vaginal area. Next, the synthetic mesh is placed to create a “sling” of support around the urethra. When your doctor is satisfied with the position of the mesh, he or she will close and bandage the small incisions in the groin area (if applicable for your sling type) and the top of the vaginal canal.

Q: How can a mid-urethral sling system help my incontinence?

A mid-urethral sling system is designed to provide a ribbon of support under the urethra to prevent it from dropping during physical activity, which may include but is not limited to laughing or lifting. Providing support that mimics the normal anatomy should prevent urine from leaking or reduce the amount of leakage.

Q: What are the types of sling options?

Many surgical options have been developed, the difference being how the mesh material is placed under the urethra. Your doctor will recommend which anchoring location is right for you.


SUI Specific after Surgery

Source: https://www.mypelvichealth.org/FrequentlyAskedQuestions/Surgery/tabid/130/Default.aspx

Q: What should I expect after surgery?

Before your discharge from the hospital, you may be given a prescription for an antibiotic and/or pain medication to relieve any discomfort you may experience. You will be instructed on how to care for your incision area. At the discretion of your physician, most patients resume moderate activities within 2 to 4 weeks, with no strenuous activity for up to 6 weeks.

Q: When will I stop leaking?

Most women see results right after the procedure. Talk with your physician about what you should expect.


PFR Questions: Diagnosis

Source: https://www.mypelvichealth.org/FrequentlyAskedQuestions/Surgery/tabid/130/Default.aspx

Q: What is Pelvic Prolapse?

Pelvic prolapse is a condition that occurs when an organ becomes displaced, or slips down in the body. You may have heard women refer to their “dropped bladder” or “fallen uterus.” This problem afflicts over 3 million women in the United States.

Q: What are some of the symptoms?

Symptoms of pelvic prolapse can include:

Q: Is there more than one form of prolapse? What are the forms or types of vaginal wall prolapse?

If your health care provider has diagnosed you with pelvic prolapse you may have one or possibly more than one of the following prolapse types.

CystocelePFR
A cystocele forms when the upper vaginal wall loses its support and sinks downward. This allows the bladder, which is located above the vagina, to drop. When a cystocele becomes advanced, the bulge may become visible outside the vagina. The visible tissue is the weakened vaginal wall; the bladder is right behind the skin but cannot be seen. The symptoms caused by cystoceles can include pressure, slowing of the urinary stream, overactive bladder and an inability to fully empty the bladder.

Rectocele
A rectocele forms when the lower vaginal wall loses its support, allowing the rectum to bulge upward. This creates an extra pouch in the rectal tube. Larger rectoceles can bulge right through the vagina. Rectoceles may cause difficulty with bowel movements including the need to strain more forcefully, a feeling of rectal fullness even after a bowel movement, increased fecal soiling and incontinence of stool or gas.

Enterocele
An enterocele forms when intestines bulge downward into the top of the vagina. The symptoms can be vague, including a bearing down pressure in the pelvis and vagina, and perhaps a lower backache. They can exist alongside vaginal vault prolapse in women who have had a hysterectomy.

Apical Prolapse
Apical prolapse is a weakening of the support structures at the top of the vagina (called the vault or apex). For women who have their uterus intact, this is referred to as uterine prolapse. When this happens, the apex sinks downward toward the vaginal opening. When the apical prolapse becomes advanced, the bulge may become visible outside the vaginal opening. The symptoms may include pressure, pain, bladder infections and difficulty urinating.


PFR Questions: Treatment Options

Source: https://www.mypelvichealth.org/FrequentlyAskedQuestions/Surgery/tabid/130/Default.aspx

Q: What are some treatment options for vaginal wall prolapse?

Vaginal wall prolapse can be treated in several minimally-invasive ways, depending on the exact nature of the prolapse and its severity.

You and your physician may discuss:


PFR Questions: Surgery

Source: https://www.mypelvichealth.org/FrequentlyAskedQuestions/Surgery/tabid/130/Default.aspx

Q: What types of materials may be used in surgical repairs?

There are several surgical materials which could be used to facilitate your repair. Types of materials include a thin, light synthetic mesh, tissue or soft graft replacement. These materials will be used to reinforce the vaginal wall back into place and stabilize your pelvic support structures. Your physician will recommend the material which is right for you.

Q: How will my surgery be performed?

Your surgical repair can be performed in a few basic ways:

  1. through minimally-invasive vaginal incisions
  2. through traditional abdominal incision
  3. through a laparoscopic approach

Hospitalization and recovery times vary for each procedure type.


PFR: After Surgery

Source: https://www.mypelvichealth.org/FrequentlyAskedQuestions/Surgery/tabid/130/Default.aspx

Q: What should I expect after surgery?

Before your discharge from the hospital, you may be given a prescription for an antibiotic and/or pain medication to relieve any discomfort you may experience. You will be instructed on how to care for your incision area. At the discretion of your physician, most patients resume moderate activities within 6 to 8 weeks, with no strenuous activity for up to 12 weeks.


PFR Glossary

Apex
The roof, or top of the vagina (also known as vault).

Cystocele
Condition in which weakened pelvic muscles cause the base of the bladder to drop from its usual position down into the vagina.

Enterocele
Condition in which weakened pelvic muscles cause the base of the intestines to bulge downward into the vagina.

Pelvic Floor
The muscles and ligaments at the base of the abdomen that support the uterus, bladder, urethra, and rectum.

Pelvic Floor Reconstruction
The surgical correction, or improving, of prolapse and incontinence.

Pessary
Device for women that is placed in the vagina to provide support for pelvic descent or prolapse of pelvic organs.

Prolapse
When one of the pelvic organs descends abnormally. Types of prolapse include: cystocele, enterocele, rectocele, uterine and vaginal vault.

Rectocele
Condition in which weakened pelvic muscles cause the rectum to bulge into the space normally occupied by the vagina.

Uterine Prolapse
Condition in which weakened pelvic muscles cause the uterus to drop from its usual position down into the apex of the vagina.

Vaginal Vault Prolapse
Condition in which weakened pelvic muscles cause the vaginal vault (apex) to drop towards the vaginal opening.

Vault
The roof, or top, of the vagina (also known as apex).


General Questions after Surgery

Q: How long will I be in the hospital?

Depending upon the type of surgery you have, you may be sent home on the day of surgery or you may stay for one or more nights. Your doctor will decide when you go home.

Q: When will I be able to get out of bed after surgery?

As soon as possible! Getting out of bed early lowers the risk of blood clots and improves how quickly you will return to normal eating.

Q: How soon after surgery can I have food?

There are usually no dietary restrictions for outpatient procedures and most vaginal surgery. Your appetite is your best guide. It is OK if you do not eat a regular meal. Do not force yourself to eat or you may vomit. You may be given medicine to help with nausea. If you are thirsty you should drink water. If you had a long abdominal surgery, your doctor may choose not to feed you for a short time. Doctors check how well your intestines are working by listening with a stethoscope, by feeling your abdomen to check for swelling and by asking you whether you have passed gas from below or had a stool.

Q: Will I need to use a catheter after surgery?

Following incontinence and prolapse surgeries, some women have difficulty emptying their bladders completely. In this case, a small tube called a catheter is commonly used to drain the bladder. The catheter is inserted into the bladder either through where you urinate (the urethra) or through a small incision on your lower belly. You may also be taught to insert the catheter into your own urethra. Physicians use these catheters to help rest the bladder and to determine how much is left in your bladder after you urinate.

Q: How long will I have to use a catheter after surgery?

The length of time you may need to use a catheter will vary. Return of normal bladder function is unpredictable. It may occur quickly after surgery or it may take a few days or weeks following the operation. This is entirely normal. Before you leave the hospital, you and your doctor will have designed the best plan for your temporary bladder problem.

If you are performing intermittent catheterization or you have a suprapubic catheter, you will be asked to keep track of how much urine is drained by the catheter. When the amount that you urinate is greater than that drained by the catheter, you are on your way to stopping the catheterization. A common time to stop using the catheter is when less than 100 mL of urine is left in your bladder after you urinate and the amount you urinate is at least 200 mL. Your doctor or the office staff will instruct you when to stop or when to have the catheter removed.

If you are sent home with a catheter in place, your doctor will have you return to the office in about a week to test if you still need the catheter. In some cases, visiting nurses may be sent to your home to do the testing and report back to your doctor.

Q: How will I receive pain medication after surgery?

Your pain medication will depend upon whether you are able to drink and eat after surgery. If you do not have nausea and can swallow them. If you can not drink or eat your pain medicine maybe placed directly through an intravenous catheter (IV). Sometimes, patients are given a small hand-held device called a PCA or patient-controlled analgesia that allows you to push a button when you want to receive pain medication. If you had an epidural for your surgery, the epidural catheter may be left in place in your back so that you can receive medication through this epidural catheter. Let your doctor or nurse know if your pain is not well controlled so they can change medications to make you more comfortable.

Q: Will I be on medication after discharge from the hospital?

You may be given a prescription for pain medication to take at home. Sometimes pain medications can cause or worsen constipation. To prevent constipation, increase fiber and water in your diet, try eating fruits, vegetables and prune juice. You can also take stool softeners and laxatives which you can buy in the pharmacy or grocery store.

Q: When will I have my first postoperative visit?

Your discharge instructions from the hospital should include when to make your first postoperative appointment. Depending upon the procedure, your doctor will want to see you within 2-6 weeks after surgery. When you return for your postoperative visit, your doctor will review your pathology report if there was tissue removed during surgery. He/she will examine you and answer any questions you may have about your recovery and your future activities. Make a list of your questions so that you do not forget them.

Q: When can I resume my normal activities?

You will receive detailed instructions describing what you should and shouldn’t do for the first 6 to 12 weeks after surgery. Everyone recovers differently. Remember that your condition, general health and operation may be quite different from a friend of yours. - When it comes to activity, use your common sense. If what you are doing causes pain or discomfort, especially at your incision or in the vagina, STOP! REST and try again in a week or two. Additional things to remember as you work toward getting back to your normal activities:


SUI:

Intended Use / Indications for Use

The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from hypermobility and/or intrinsic sphincter deficiency.

Contraindications

A mesh implant is contraindicated in the following patients:

Warnings/Potential Complications

As this product is intended for use by clinicians with adequate training and experience in the treatment of female stress urinary incontinence (SUI), the risks and benefits of a suburethral sling procedure in the following should be carefully considered:

The following complications have been reported due to suburethral sling placement, but are not limited to:

*Transobturator procedure only


PFR:

Considerations Prior to Surgical Repair

If you are considering pelvic floor reconstruction surgery your physician may ask you questions about your medical history, to ensure you are a candidate for this type of procedure. Some of these contraindications, warnings/potential complications, and adverse events associated with pelvic floor reconstruction are listed below as a reference to you. You should consult your physician for a complete understanding of this information and to determine whether this procedure is right for you.

Intended use / Indications for use

Mesh based transvaginal surgeries are indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended.

Contraindications

Warnings/Potential Complications

Adverse Events

Potential adverse reactions that are associated with gynecological surgical mesh include:
Abscess formation/Foreign body reaction; adhesion formation; allergic, hypersensitivity or other immune reaction; bruising, hematoma, hemorrhage; constipation; dehiscence and/or necrosis; dyspareunia; erosion/extrusion; Fistula formation; granulation tissue formation; infection/sepsis potentiation; inflammation (acute or chronic); mesh and/or tissue contracture; organ perforation; pain, discomfort, irritation; post-operative bleeding; recurrent prolapse; surgical site wound irritation, erythema, edema; ureteric injury; ureter obstruction; urinary incontinence; urinary retention; vaginal discharge; vaginal shortening or stenosis; vessel/nerve injury/perforation; wound dehiscence


Sources:

AUGS (American Urogynecologic Society)
https://www.mypelvichealth.org/FrequentlyAskedQuestions/Surgery/tabid/130/Default.aspx

BSC SUI Patient brochure (MVO1900 7/10)
http://www.bostonscientific.com/templatedata/imports/HTML/PFI_Patient/images/SUI_learn_more_pfi.pdf

BSC PFR Patient brochure (MVO1890 7/10)
http://www.bostonscientific.com/templatedata/imports/HTML/PFI_Patient/images/pelvic_floor_learn_more_pfi.pdf

WH-20601-AA