Frequently Asked Questions (FAQ)

LIMITED GUARANTEE FOR MESH PELVIC RECONSTRUCTIVE SURGERY

1. What is the limited guarantee? Saint Luke’s Hospital of Bethlehem, Pennsylvania d/b/a St. Luke’s Hospital & Health Network (St. Luke’s) and The Institute for Female Pelvic Medicine & Reconstructive Surgery (IFPM) have agreed not to bill eligible patients or their insurance companies (if applicable) for any charges associated with pelvic reconstructive surgery utilizing mesh at St. Luke’s performed by physicians employed by IFPM, if:

• St. Luke’s or IFPM fails to follow a specific care plan; or

• an eligible patient experiences any of three specific undesired outcomes.

In addition, St. Luke’s and IFPM have agreed not to bill eligible patients or their insurance companies (if applicable) for charges associated with readmission to St. Luke’s within thirty (30) days following the date a patient undergoes the pelvic reconstructive surgery utilizing mesh at St. Luke’s as a direct result of an adverse outcome caused solely by an IFPM urogynecologist’s technical portion of the surgery performed at St. Luke’s.

2. Why are St. Luke’s and IFPM offering the limited guarantee? The care plan is designed to improve patient outcomes, and the limited guarantee is intended to demonstrate the desire of St. Luke’s and IFPM to follow certain practices and procedures in furtherance of improved patient outcomes. However, St. Luke’s and IFPM cannot guarantee specific outcomes for patients. For example, the three undesired outcomes are atypical, but they may occur from time to time. In addition, any failure to follow the care plan or the occurrence of an undesired outcome or a readmission is not intended to constitute an acknowledgement of fault or wrongdoing by St. Luke’s, IFPM or IFPM’s physicians.

3. What is the Mesh Pelvic Reconstructive Surgery Care Plan? St. Luke’s and IFPM have developed and implemented at St. Luke’s a multi-faceted care plan intended to direct the pre-operative and inpatient process for eligible patients who undergo pelvic reconstructive surgery utilizing mesh at St. Luke’s.

4. Will the plan still be followed if a patient of IFPM does not want to participate in the guarantee? Yes. We expect that the plan will be followed for every patient of IFPM who undergoes pelvic reconstructive surgery utilizing mesh at St. Luke’s.

5. What are the three specific undesired outcomes? The three undesired outcomes are: (a) rectal injury requiring fecal diversion and/or additional procedures related to rectal injury; (b) urethral injury that is not repaired during the surgery; and (c) prolonged voiding dysfunction requiring retention of a foley catheter by a patient for more than thirty (30) days following the date the patient undergoes the surgery.

6. Why did we choose these outcomes? We believe that these should typically be preventable when pelvic reconstructive surgery utilizing mesh is performed by a qualified surgeon.

7. If an IFPM patient is readmitted following pelvic reconstructive surgery utilizing mesh, will the patient and her insurance company (if applicable) be charged by IFPM and St. Luke’s? It depends. St. Luke’s and IFPM have agreed not to bill eligible patients or their insurance companies (if applicable) for charges associated with any readmission to St. Luke’s within thirty (30) days of the procedure as a direct result of an adverse outcome caused solely by an IFPM urogynecologist’s technical portion of the pelvic reconstructive surgery utilizing mesh performed at St. Luke’s. This does not include a readmission caused by an adverse outcome if the adverse outcome is not caused solely by an IFPM urogynecologist’s technical portion of the surgery.

8. What are some examples of adverse outcomes not caused solely by an IFPM urogynecologist’s technical portion of a pelvic reconstructive surgery utilizing mesh? If an eligible patient experiences an adverse outcome associated with the use of the graft insertion (mesh) requiring mesh revision, or infection, erosion, chronic inflammation, acute or chronic pain, pain with intercourse, fistula, disturbance in bowel or bladder function, or if an eligible patient experiences other adverse outcomes unrelated to the mesh insertion, such as a heart attack, stroke or pulmonary embolism during or following the surgery requiring readmission, the adverse outcome would not be caused solely by an urogynecologist’s technical portion of the surgery and thus the adverse outcome resulting in the readmission would not be covered by the limited guarantee.

The adverse events listed in the prior sentence are only examples and are not intended to include all adverse events not caused solely by an IFPM urogynecologist’s technical portion of a pelvic reconstructive surgery utilizing mesh.

9. Who is eligible for this limited guarantee? The limited guarantee applies only to patients (a) of IFPM; (b) who have had no prior reconstructive pelvic surgery; (c) who do not have at the time of surgery neurological disease that adversely impacts bladder function; (d) who undergo the surgery at St. Luke’s; (e) who sign a patient acknowledgment; and (f) with respect to patients who experience a readmission to St. Luke’s within thirty (30) days of the procedure as a direct result of an adverse outcome caused solely by an IFPM urogynecologist’s technical portion of the pelvic reconstructive surgery utilizing mesh performed at St. Luke’s, who are readmitted to St. Luke’s for treatment. IFPM will notify a patient prior to surgery if the patient has a co-morbidity factor which makes the patient ineligible to participate in the limited guarantee.

10. Which surgeons are offering this guarantee? IFPM currently includes only the following physicians: Vincent Lucente, M.D., Miles Murphy, M.D. However, IFPM may hire or engage additional physicians from time to time. Also, the above named physicians may cease practicing through IFPM. Accordingly, the patient should confirm that her physician is employed or engaged through IFPM at the time of surgery to ensure that the limited guarantee applies.

11. What happens if an eligible patient is readmitted to a different hospital other than St. Luke’s? If an otherwise eligible patient is admitted to a hospital other than St. Luke’s as a direct result of an adverse outcome caused solely by an IFPM urogynecologist’s technical portion of the pelvic reconstructive surgery utilizing mesh performed at St. Luke’s, the patient is not eligible to participate in the limited guarantee.

12. Does the limited guarantee apply to materials used in the surgery? No. Pelvic reconstructive surgery utilizing mesh typically involves the placement of synthetic mesh through small incisions to provide durable support for pelvic organs. The limited guarantee does not apply to the surgical mesh inserted during the surgery. For example, the limited guarantee would not apply if the surgical mesh erodes or if other complications develop from the mesh insertion. Each IFPM patient is given a copy of the labeling from the surgical mesh manufacturer prior to surgery. The labeling includes important information concerning certain risks the patient assumes in connection with the mesh placement. The limited guarantee does not apply to adverse outcomes associated with the mesh itself.

13. What should an IFPM patient read in order to understand the FDA notification concerning pelvic reconstructive surgery utilizing mesh? The U.S. Food and Drug Administration (FDA) issued an alert on October 20, 2008 relating to serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence, which each patient contemplating the surgery should read. Prior to undergoing the surgery, each IFPM patient must acknowledge that she was advised of the FDA alert. In addition, IFPM issued a position paper in response to the FDA alert, which is available from IFPM to its patients contemplating the surgery upon request to IFPM.

14. What does an eligible patient need to sign to participate in the limited guarantee? In order to be eligible for the limited guarantee, a patient must execute prior to the surgery a patient acknowledgement in the form delivered by IFPM. The patient acknowledgement includes a verification by the patient that certain portions of the mesh pelvic reconstructive surgery care plan have been performed, such as a discussion between the physician and the patient concerning other treatment options. The patient must also agree to follow her pre- and post-surgical instructions.

15. Does the guarantee cover all services related to the surgery? Certain third parties other than St. Luke’s and IFPM, including certain affiliates of St. Luke’s, may provide services in connection with a pelvic reconstructive surgery utilizing mesh performed at St. Luke’s, the treatment of an undesired outcome or treatment provided during a readmission. For example, an anesthesiologist may provide and bill for professional services performed in connection with the surgery or a cardiologist may provide consultative services during a patient’s recovery at St. Luke’s. The limited guarantee is not intended to, and does not, preclude these professionals from billing a patient or her insurance company for services provided, including such professionals employed or engaged by St. Luke’s or its affiliates.

16. How does a patient make a request not to be billed under the guarantee? If an eligible patient believes that she or her insurance company (if applicable) should not be billed for the pelvic reconstructive surgery utilizing mesh or a readmission, the patient must deliver written notice to IFPM within ninety (90) days following the date of the surgery at the following address:

The Institute for Female Pelvic Medicine
& Reconstructive Surgery
3050 Hamilton Blvd, Suite 200
Allentown, PA 18104
Attn: Kimberly Pammer

A patient must provide a detailed written description of the reasons why she or her insurance company (if applicable) should not be billed. If requested by IFPM, the patient must submit to one (1) or more physical examinations by a physician employed or engaged by IFPM, so that the physician may adequately evaluate the patient and determine whether the limited guarantee applies.

17. Can the guarantee terms change? Yes. The terms of the limited guarantee may change from time to time. Patients should revisit the terms and conditions prior to undergoing the surgery. The latest terms and conditions and care plan posted at [NOTE: Insert link] at least five (5) days prior to the date of surgery applies to a patient.

18. What if there is a dispute? In the event of a dispute concerning an alleged failure to follow the care plan, an alleged occurrence of an undesired outcome or an alleged readmission arising under the limited guarantee, the dispute will be submitted to a panel consisting of Michael Patriarco, M.D., John Willis, M.D. and Joseph Merola, M.D., who serves as the Chief of Obstetrics at St. Luke’s. The panel will consider in its sole discretion information it deems relevant in making a determination, which decision will be final. If requested by the panel, the patient must meet with members of the panel, so that the panel may review the patient’s assertions. The patient may be required to answer questions from the panel. If requested by the panel, the patient must undergo a physical examination by all or select members of the panel. The panel may review the patient’s medical records, including any physical examination conducted by IFPM. In the event of a disagreement among members of the panel, a decision by a majority of the members of the panel will control.

19. Can I use the terms of the guarantee in a medical malpractice claim against St. Luke’s, IFPM and/or the IFPM physicians? No. A failure to follow the care plan, the occurrence of an undesired outcome or a readmission covered by the limited guarantee is not an acknowledgement of fault or wrongdoing by St. Luke’s, IFPM or IFPM’s physicians and cannot be considered an admission of liability by St. Luke’s, IFPM or IFPM’s physicians. The limited guarantee cannot be used as evidence in any legal proceeding alleging professional negligence or misconduct. In fact, the standards set forth in the limited guarantee may be a higher standard than the applicable standard of care required by law.

THESE FREQUENTLY ASKED QUESTIONS ARE INTENDED TO ASSIST YOU IN YOUR INTERPRETATION OF THE TERMS AND CONDITIONS APPLICABLE TO THE LIMITED GUARANTEE. HOWEVER, YOU SHOULD READ THE TERMS AND CONDITIONS CAREFULLY. IN THE EVENT OF A DISPUTE BETWEEN THESE FREQUENTLY ASKED QUESTIONS AND THE TERMS AND CONDITIONS, THE TERMS AND CONDITIONS SHALL CONTROL.

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