Importance of Patient Safety | Informed Consent | Centers of Excellence | Complications with Vaginal Mesh | Frequently Asked Questions | SUI Pre-Op | POP Counseling

Importance of Patient Safety

The reason for increasing the attention on patient safety was triggered by the Institute of Medicine (IOM) which issued two landmark reports over a decade ago on how much medical errors were costing our country in terms on money and lives. The importance of eliminating medical errors continues to be a high priority for all healthcare providers, especially hospitals that are no longer being reimbursed for expenses associated with events occurring in the hospital that never should have happened, such as a new pressure ulcer, urinary tract infection, etc.

Informed Consent

According to the American Medical Association (AMA), informed consent “is a process of communication between a patient and physician that results in the patient’s authorization or agreement to undergo a specific medical intervention.”

The patient needs not only to be informed of risks, but also to be able to discuss those risks to facilitate shared decision –making regarding plans for treatment or intervention. The starting point for understanding and participating in the shared decision making process is education.  An educated patient is undoubtedly a safer patient. Health Care Professionals should discuss and disclose with the patient:

• The patient's diagnosis;
• The nature and purpose of a proposed treatment or procedure;
• The risks - and the likelihood associated with those risks - and expected benefits of a proposed treatment or procedure;
• Alternatives;
• The risks and benefits of the alternative treatment or procedure;
• The risks and benefits of not receiving or undergoing a treatment or procedure;
• The self-care treatment the patient will be expected to provide following a procedure;
• What to expect immediately after the treatment or procedure, e.g., short-term pain and how to manage it;
• The signs of complication and when to contact/follow-up with a health care professional or even the Emergency Department

The patient should ask for evidence of training in the procedure and verify that the doctor is Board certified. The patient should understand what is involved in a hospital’s credentialing of providers at its facility.

If the patient lacks the mental capacity to understand or the physical ability to participate in the process of discussion, an appointed family member or close friend should serve as the patient’s representative.  When the provider provides the patient with a recommended plan of action, the provider should also disclose information about his or her experience in performing the recommended procedure as well as alternative intervention. In addition, the provider should disclose any possible factors influencing recommendations being made to the patient, such as financial benefit from companies making the recommended device or drug. A financial benefit could include such roles as that of a paid consultant to the company or a substantial personal investment in the company.

The patient should fully comprehend their treatment or procedure plan. The patient should give full consent in favor of the agreed upon plan and authorization for all elements of the procedure or treatment. The exceptions for authorization and consent include emergency, incapacity, patient waiver, when a patient becomes a threat to one’s self or others, and national waivers (vaccinations).

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Centers of Excellence in Continence Care

To support improvement in the standard of care, it is NAFC’s mission to help women identify such experts through NAFC designated Centers of Excellence in Continence Care that demonstrate not only appropriately trained, experienced, and credentialed experts but also satisfaction in outcomes and care by a majority of their patients. This initiative is unfolding, as three Centers have been named thus far in continence care for women.  The current process of designation requires extensive applications by an interdisciplinary team connected with a tertiary care hospital, evidence of sufficient surgery volumes to demonstrate competence by two or more surgeons, a two-day site visit with extensive, personal interviews with all key players, and a survey of patients of a sample size to be considered of statistical significance. The designation process generally requires 12-18 months of time to complete and must be renewed every 3 years.  To identify those physicians who are part of a team of such designated experts, look for the gold seal signaling a Center of Excellence beside the name of the individual listed in NAFC’s Find An Expert database on the homepage of this web site.

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Complications Associated With Vaginal Mesh

FDA Public Health Notification:
On October 20, 2008, the U.S. Food and Drug Administration sent an alert to health care practitioners in regards to complications associated with surgical mesh used to treat pelvic organ prolapse and stress urinary incontinence. The altert contained information about adverse events that have been reported to the FDA and recommendations to reduce the risks. The notification can be read in full here.

FDA Safety Communication:
On July 13, 2011, the U.S. Food and Drug Administration issued a safety communication, updating its 2008 Public Health Notification about the complications with surgical mesh. The FDA is issued this update to inform the public that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. The safety communication can be read here.

FDA Update on Review Process Regarding Urogynecologic Surgical Mesh Implants:
On January 4, 2012 the U.S. Food and Drug Administration issued an update in regard to its Safety Communication about Surgical Mesh. The entire update can be read here. Based on assessment of Medical Device Reports (adverse event reports) submitted to the FDA, evaluation of the published literature, and the September 2011 Obstetrics-Gynecology Devices Panel meeting, the FDA is considering the recommendation that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) be reclassified from Class II to Class III.

The class to which your device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to market. If your device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing. For Class III devices, a premarket approval application (PMA) will be required

FDA Urogynecologic Surgical Mesh Implant Website Now Includes SUI Information
On March 27, 2013 the FDA updated the Urogynecologic Surgical Mesh Implant website to include more information for patients about stress urinary incontinence (SUI). The information about SUI can be found here.

NAFC’s Position Statement on FDA Communication:

NAFC supports the position statements of AUGS and ACOG as they reinforce NAFC's own position statement. On August 2, 2011, NAFC issued their position statement in regard to the July 2011 FDA Safety Communication about surgical mesh. Below is the statement.

1. As every patient is unique, the individuality of the patient and her input must be considered.
2. The patient needs to be educated well enough to understand for her diagnosis and treatment options. These should be discussed openly with the doctor so together they can agree on a course of action.
3. The medical societies must establish standards for surgery and training of doctors treating pelvic organ prolapse (POP) and stress urinary incontinence (SUI).  Patients should be educated to see proof of such training and be offered options in care.
4. NAFC does not support the withdrawal of mesh from the marketplace.  Women who have already had mesh implanted surgically have no reason to have it removed unless they are witnessing severe complications.
5. Long term analysis of data for improved knowledge is necessary.
6. NAFC encourages open dialogue with all parties – industry, providers, payers, and patient advocacy groups – on issues patient safety and patient access to innovation for continuously improved quality outcomes in care.

• FDA Public Health Notification (10/20/2008)
• FDA Safety Communication Update (07/13/2011)
• FDA NAFC Position Statement (08/2/2011)
• AUGS and ACOG Joint Committee Opinion on Vaginal Placement of Synthetic Mesh for POP (11/21/2011)
• Committee Opinion #513 "Vaginal Placement of Synthetic Mesh for Pelvic Organ Placement" is published in the December 2011 issue of Obstetrics & Gynecology. (12/2011)
• Update regarding Transvaginal Mesh Sales (07/2012)
• AUGS Position Statement on Restriction of Surgical Options for Pelvic Floor Disorders (03/2013)

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Frequently Asked Questions

Many patients have asked questions about the FDA Communication. With our help, American Medical Systems, Inc. (AMS), a member of NAFC's Industry Council and a marketer of both midurethral mesh slings and the newer slings prepared this "Frequently Asked Questions" document for a consumer that is designed to assist with questions patients may have about the FDA communication. The FAQ document is designed to be completely brand neutral resource for use by all parties.

FAQ regarding Transvaginal Mesh for Pelvic Organ Prolapse

FAQ regarding Sling Surgery for Stress Urinary Incontinence

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SUI Pre-Op Counseling and Discussion

The patient needs not only to be informed of risks, but also to be able to discuss those risks to facilitate shared decision –making regarding plans for treatment or intervention. Health Care Professionals should discuss and disclose with the patient the alternatives to a treatment or procedure.  Patients should be well informed of alternatives and made known that the doctor is well trained in performing alternative treatments or procedures. The informed consent should include authorization for inter-operative cystoscopy to watch for perforation of the urethra or bladder if a standard mesh sling procedure is being performed. The patient should ask their health care professional if they are a candidate for a mini-sling procedure as it offers the possibility of fewer complications and only one incision. Health care professionals should label the medical record with the unique device identifier (UDI) for the device ultimately implanted in case of recall or other FDA notifications.

1. What are the possible complications with traditional bladder neck and Burch suspensions (i.e., tissue-to-tissue repair without mesh)?
   • Greater interoperative bleeding
   • Greater risk of bowel/bladder injuries
   • Deep vein thrombosis  (DVT) and pulmonary embolism (PE)
   • Abdominal wound healing complications
   • Greater post-op voiding dysfunction
   • More post-operative pain
   • Recurrence of incontinence
2. What are the adverse effects from standard, mid-urethral mesh slings? For definitions of these terms please click here.
   • Groin or leg pain
   • Mesh erosions (perforations) and mesh exposure into the vagina
   • Infection (UTI)
   • Urinary problems (retention)
   • Organ perforation
   • Recurrence of incontinence
   • Bleeding
   • Dyspareunia
   • Neuro-muscular problems
   • Vaginal scarring
3. How are complications with standard, mid-urethral mesh slings typically handled?
   • Risk of exposure decreases with surgeon experience
   • Dyspareunia is usually related to superficial placement and can be corrected
   • Most complications can be easily treated
     • Topical estrogen application
     • Minor surgical excision or in-office trimming of exposed mesh

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POP Counseling and Discussion: Type of Prolapse

• Severity
• Prior prolapse surgery and the risk of recurrent prolapse (progressive: the number and degree of recurrence rate increases overtime)
• Medical co-morbidities that present additional risk factors
• Concomitant pelvic symptoms (e.g., pelvic pain prior to surgery at baseline)
• Patient risk factors (smoking, diabetes, hysterectomy, )
• Complication of disease
• Individualized care plan

Best suited for mesh for POP:

1. Cystocele – anterior vaginal wall prolapse
2. Prior prolapse – prior surgery for prolapse

Mesh exposures do increase in time but are not usually serious enough in the large majority of cases to return the patient to the operating room.

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