Interactive Pelvic Organ Prolapse - Quantification (POP-Q) Program Disclaimer
Use of Interactive Pelvic Organ Prolapse Quantification (POP-Q) Program The Interactive Pelvic Organ Prolapse Quantification (POP-Q) Program is designed to assist qualified Healthcare Professionals in counseling patients about pelvic organ prolapse and related conditions.
The resources offered in this program are intended for use solely by Healthcare Professionals to aid in visually presenting pelvic organ prolapse exam results to patients. The information presented here is not for use as a guide to treatment decisions about the care of individual patients. It is not medical advice or a substitute for medical advice. This program does not replace the responsibility of the treating physician for patient treatment.
The information presented in the Interactive Pelvic Organ Prolapse Quantification (POP-Q) Program is adapted from medical consultation and peer-reviewed publications. Boston Scientific (BSC) makes a reasonable effort to assure that the information presented is current and accurate. But it cannot guarantee or take responsibility for the accuracy or sufficiency of the information provided by medical consultants or peer-reviewed publications. The responsibility for treatment decisions and for ensuring the accuracy of a diagnosis and treatment information rests with the treating Healthcare Professional.
Neither BSC nor Visible Body makes any warranty, express or implied, or representation of any kind regarding the Interactive Pelvic Organ Prolapse Quantification (POP-Q) Program or the information presented in this program. The Interactive Pelvic Organ Prolapse Quantification (POP-Q) Program is provided "AS IS." Visible Body and BSC expressly disclaim liability for any and all claims arising from use of the Interactive Pelvic Organ Prolapse Quantification (POP-Q) Program or the content of this program.
Intellectual Property Rights
The materials made available in this program are the intellectual property of Visible Body and/or third parties. Visible Body reserves all copyright, trademark, and other intellectual property rights to these materials.
As a registered user of the Pelvic Floor Institute, you are permitted to display and view this program and the materials presented here for internal purposes only. You are not permitted to copy, paste, reproduce, publish, modify, translate, resell, redistribute or transmit any portion of information or content of this program without the written permission of BSC. You agree that you will not decompile, reverse engineer or duplicate the look and feel of this program or its content, or attempt to do so.
As a registered user of the Pelvic Floor Institute, you agree to honor these intellectual property rights.
Accordingly for medical devices: Federal (USA) law restricts these devices to sale by or on the order of a physician. Refer to package insert provided with these products for complete Instructions for Use, including Indications for Use, Contraindications, Warnings, Precautions and Adverse Events prior to using products. Boston Scientific products may not be for sale in certain countries. Please check availability with your local sales representative or customer service.
INDICATIONS: Coaptite Injectable Implant is indicated for soft tissue augmentation in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult females.
CONTRAINDICATIONS: The Coaptite Injectable Implant is contraindicated for use in a patient: who has significant history of urinary tract infections without resolution; who has current or acute conditions of cystitis or urethritis; who has fragile urethral mucosal lining. POTENTIAL ADVERSE EFFECTS that may occur include: genitourinary adverse events (i.e., urinary retention, hematuria, dysuria, UTI, urinary urgency and frequency), erosion, erythema, embolic phenomena, and vascular occlusion.
WARNINGS: Note: Failure to follow any instructions or to heed any Warnings or Precautions could result in serious patient injury. WARNING: Following injection of Coaptite Implant, dissection of the device through tissue may lead to 1) tissue erosion and may require corrective surgery or 2) elevation of the bladder wall causing ureteral obstruction. This may be caused by improper injection technique using Coaptite Implant. (See adverse event section in IFU for further information.)
WARNING: Women with peripheral vascular disease and prior pelvic surgery may be at increased risk for tissue erosion following injection of Coaptite Implant. (See adverse event section in IFU for further information.) Please refer to complete instructions for use for a complete listing of all warnings and potential adverse effects. CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician trained in diagnostic and therapeutic cystoscopy.
CAUTION: The law restricts devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in product labelling supplied with each device. Information for use only in countries with applicable health authority registrations. Material not intended for use in France.
IMPORTANT INFORMATION: These materials are intended to describe common clinical considerations and procedural steps for the use of referenced technologies but may not be appropriate for every patient or case. Decisions surrounding patient care depend on the physician’s professional judgment in light of all available information for the case at hand. Boston Scientific (BSC) does not promote or encourage the use of its devices outside their approved labeling.
For more information visit the FDA's Urogynecologic Surgical Mesh Implants website at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm
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