Men’s Health Product Catalog - ColoplastMD€¦ · are designed to be surgically implanted in the penis for the management ... grade stainless steel dilators; 8 mm, 9 mm, 10 mm,

Men’s Health

Product Catalog

2 | Men’s Health Catalog - Urology 3

Table of Contents

Erectile Dysfunction 4

Titan® 3-Piece Inflatable Penile Prosthesis 6

Genesis® Malleable Penile Prosthesis 10

Surgical Instrumentation 11

Male Urinary Incontinence 12

Virtue® Male Sling System

Testicular Replacement 13

Torosa® Saline-Filled Testicular Prosthesis

Peyronie’s Disease 13

Tutoplast® Processed Pericardium

Ordering Information 14

It all started back in 1954. Nurse Elise Sorensen was concerned by the dramatic change in her sister’s lifestyle following an ostomy operation. She came up with the idea of an ostomy bag with an adhesive ring, which would make it fit tightly to the skin. This would give her sister – and thousands of people like her – the chance to return to their normal life.

Today, Coloplast’s business includes ostomy care, continence care, urology care, wound care and skin care. We work closely with people who have intimate healthcare needs. We listen to their needs and respond with products that help make their lives easier.

With a world class innovative spirit and the ultimate objective of always being able to make life easier, Coloplast presents its latest dedicated Men’s Health Urology Care catalog across four disease states:

• Erectile Dysfunction: Inflatable Penile Prosthesis (Titan®) & Malleable Penile Prosthesis (Genesis®)

• Male Urinary Incontinence: Male Sling (Virtue®)

• Testicular Replacement: Testicular Prosthesis (Torosa®)

• Peyronie’s Disease: Processed Pericardium (Tutoplast®)

Coloplast is proud to provide you with the highest level of services, products and support.

Our Customer Service and Sales Representatives are available whenever you need them to help you find the right solutions to your specific requirements.

To Order Call Toll-Free 800.258.3476 These products may be ordered directly from Coloplast.

Products to help make life easier

The Coloplast History

Coloplast offers the Titan® family of Inflatable Penile Prosthesis (IPPs) for those men that need surgical intervention. The Titan family of products are designed to be surgically implanted in the penis for the management of erectile dysfunction. The implant consists of two Bioflex® cylinders that are implanted in the corpora cavernosa of the penis. The cylinders are attached to a pump that is placed in the scrotum. The pump is connected to a reservoir, filled with sterile saline solution and is implanted in the Space of Retzius or underneath the abdominal muscles.6

5

ED afflicts 30 million men in the US and nearly 100 million men worldwide.8

Erectile Dysfunction (ED)

Titan and Titan Touch PumpThe Titan IPP is available with two different pump options to fit the needs of the physician and the patient. The Titan Touch pump is a one touch release pump that may streamline patient training7, while the Titan pump is a simple and softer option for those patients who may have more difficulty depressing the pump.

Titan Cloverleaf ReservoirThe unique Titan Cloverleaf reservoir may allow for easier implantation technique.9 The cloverleaf shape allows for more fluid (larger volumes) to be filled in a smaller-footprint reservoir.10

Titan® Family of IPP ProductsThe Titan family of IPP products are available in a variety of lengths ranging from 11 cm to 28 cm, with two different pump options. All standard and narrow base cylinders are provided pre-connected to the pump and the XL cylinders are available as separate components. All components of the Titan IPP products incorporate a hydrophilic coating on all external surfaces that gives a physician their choice of aqueous solution to coat the device and may promote easier device implantation.1

Titan Zero Degree Angle Tubing and Soft TipThe Titan family of IPP products feature zero degree angle exit tubing at the proximal base of the cylinder that uniquely varies in tubing length depending on the length of the cylinder and a soft silicone molded distal tip on the cylinder. These features are designed for suitable anatomic positioning and can offer minimal dilation and easier proximal placement of the product.1

Important Risk Information: The Titan Penile Prosthesis requires surgery. Risks of surgery may include but are not limited to complications such as infection, swelling, pain and discomfort. Once implanted, the system may present the opportunity for infection, erosion, product migration or device malfunction which may require additional surgery.

4 | Men’s Health Catalog - Urology

Titan®

• The Bioflex® material of the cylinders allows for unmatched cylinder strength and rigidity1

• Reduced risk of auto-inflation with Lock-out™ valve on the reservoir1

• Hydrophilic coating to aid in surgical placement2

• Zero degree angle proximal input tubing for ease of surgical placement1

• Soft molded tip designed for suitable anatomic positioning1

• Tubing length varies depending on length of cylinder to allow for proper pump placement


Titan® Touch Inflatable Penile Prosthesis3-Piece Inflatable Penile Prosthesis with Hydrophilic Coating and One Touch Release Pump

• Touch pump: one touch of the deflate button allows for easy deflation of the device1

• The Bioflex® material of the cylinders allows for unmatched cylinder strength, girth and rigidity1

• Reduced risk of auto-inflation with Lock-out™ valve on the Cloverleaf reservoir1

• Hydrophilic coating to allow a physician to use the aqueous solution of their choice to minimize infection risk and aid in surgical placement2

• Zero degree angle proximal base input tubing for ease of surgical placement1

• Soft molded tip designed for optimal anatomic positioning1

• Tubing length varies depending on length of cylinder to allow for proper pump placement

Titan® Touch

Product Length Order Number

Titan Touch – Infrapubic 14 cm ES2814

16 cm ES2816

18 cm ES2818

20 cm ES2820

22 cm ES2822

Titan Touch – Penoscrotal 14 cm ES2914

16 cm ES2916

18 cm ES2918

20 cm ES2920

22 cm ES2922

Titan® Touch Narrow BaseFor narrow corpora cavernosa


Titan Touch Narrow Base – Infrapubic 11 cm EN2811

14 cm EN2814

16 cm EN2816

18 cm EN2818

Titan Touch Narrow Base – Penoscrotal 11 cm EN2911

14 cm EN2914

16 cm EN2916

18 cm EN2918

Titan® Narrow BaseFor narrow corpora cavernosa


Titan – Infrapubic 14 cm ES8814

16 cm ES8816

18 cm ES8818

20 cm ES8820

22 cm ES8822

Titan – Penoscrotal 14 cm ES8914

16 cm ES8916

18 cm ES8918

20 cm ES8920

22 cm ES8922


Titan Narrow Base – Infrapubic 11 cm EN8811

14 cm EN8814

16 cm EN8816

18 cm EN8818

Titan Narrow Base – Penoscrotal 11 cm EN8911

14 cm EN8914

16 cm EN8916

18 cm EN8918


Erectile Dysfunction

Titan® Inflatable Penile Prosthesis3-Piece Inflatable Penile Prosthesis with Hydrophilic Coating


Titan Cloverleaf Reservoir With Lock-out™ Valve

• The only IPP with a true Lock-out valve located at the base of the reservoir to prevent early auto-inflation1

• Hydrophilic coating is absorbing to allow for your choice of aqueous solution1

XL Cylinder SetColoplast offers the longest penile prosthesis cylinders on the market.6,11 The XL cylinder set and pump must be purchased separately and connected with the Coloplast True-Lock® Connectors found in the Standard Assembly Kit.

Titan® ComponentsFor use with the Titan Inflatable Penile Prosthesis family of products

Standard Assembly KitThe standard assembly kit contains the components that are used to facilitate assembly of the Titan IPP

Contains: True-Lock® Connector**Rear Tip Extenders (locking)Keith NeedleCylinder Protector ToolGreen Tip for filling the deviceShod Tubing

**Consisting of connector sleeves and connector

Pump Assembly

True-Lock® Plug The True-Lock Plug system is supplied separately and consists of a plug and clamp that is utilized to close an unused tube, where deemed appropriate.

Titan® ComponentsFor use with the Titan Inflatable Penile Prosthesis family of products

Product Order Number

Titan Standard Assembly Kit 9480SC

Narrow Base Rear Tip Extenders Kit*


Narrow Base Rear Tip Extenders Kit* 519300

*Titan Zero Degree Narrow Base Rear Tip Extender Kit must be purchased with the Titan Standard Assembly Kit when used with a Narrow Base product


Titan Cloverleaf Reservoir 75 cc ER8075

125 cc ER8125


Titan XL Cylinder Set 24 cm E17924

26 cm E17926

28 cm E17928


Titan Pump Assembly 517770

Titan Touch Pump Assembly 517750


True-Lock Plug 9471S




Genesis® Malleable Penile Prosthesis2-Piece Flexible Penile Prosthesis with Hydrophilic Coating

The Genesis Malleable Penile Prosthesis not only offers simplicity for surgeons3, but also offers a simple solution for patients with finger or hand dexterity issues, hand muscle fatigue, limited reach and range of mobility.12

• Hydrophilic coating to allow a physician to use the aqueous solution of their choice to minimize infection risk and aid in surgical placement3

• No springs, cables, or moving internal parts to compromise reliability

• Trimmable – custom sizing to fit to each individual’s corporal length3

• Easy assembly – no special tools required, simply connect3

Brooks™ Corporal Dilator Set13

Designed by physicians to allow for gradual dilatation of the corpora cavernosa before the implantation of a penile prosthesis.13 Brooks dilators are non-sterile, reusable, stainless steel dilators.13 Each set consists of seven dilators; 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm and 14 mm.

Rossello Corporal Dilator Set14

A set of rasped dilators that are intended to remove scar tissue while dilating the fibrotic corpora cavernosa. The device is a set of five non-sterile, reusable, medical grade stainless steel dilators; 8 mm, 9 mm, 10 mm, 11 mm and 12 mm.

Wilson Male Retractor SystemThe Wilson Penile Implantation System was designed by Steven K. Wilson, M.D., F.A.C.S. It is a complete retractor set to aid with the penoscrotal approach to implanting a penile prosthesis and is supplied sterile.

Contains:1 - Retractor Frame (30.4 cm x 19 cm)6 - Blunt Tip Stay Hooks (12 mm)1 - Sharp Tip Stay Hook (5 mm)2 - Rake Stays (20 mm, 3 fingers)2 - Small Disposable Deavers1 - Elevation Strap

Product Diameter Length (Min.-Max.) Order Number

Genesis 9.5 mm 14-23 cm 91-9509SC

11 mm 16-25 cm 91-9511SC

13 mm 18-27 cm 91-9513SC


Wilson Male Retractor System TLC-5042-M


Brooks Corporal Dilator Set 9350


Rossello Corporal Dilator Set QB5558



Penile Prosthesis Surgical Instrumentation


Peyronie’s Disease

Tutoplast® Processed Pericardium Peyronie’s Disease is a condition marked by penile curvature, with or without pain upon erection. It is a condition that can appear in men of all ages and results in deformities of the penis.18

Coloplast offers the pericardium allograft tissue – preserved donated human tissue that has been sterilized through the Tutoplast tissue sterilization process.19 This allograft conforms easily to flatten against irregular surface profiles and provides a scaffold for the body’s natural regenerative healing.20

Torosa® Saline-Filled Testicular ProsthesisColoplast’s patented Torosa® Saline-Filled Testicular Prosthesis aids in restoring a more natural appearance in people missing one or two testicles.4 The weight, shape and soft texture are designed to mimic the natural testicles.4 Coloplast offers the only FDA-approved testicular implant for adults and children17 for use when cosmetic testicular replacement is indicated i.e., in the case of agenesis or following the surgical removal of a testicle.5

The device consists of a molded silicone elastomer shell, with a self-sealing injection site5 located on one end of the prosthesis. This injection site allows the implanting surgeon to fill the device with sterile, pyrogen free Sodium Chloride U.S.P. solution for injection. On the end opposite of the fill site is a silicone elastomer tab for suturing the prosthesis in position if desired.4 The device is not visible on x-ray.5

Torosa Testicular Prosthesis is available in four sizes: extra small, small, medium & large.


Virtue Male Sling System 50020

Product Size Dimensions Order Number

Torosa Extra Small 2.2 x 3 cm 450-1323

Small 2.5 x 3.5 cm 450-1325

Medium 2.7 x 4.0 cm 450-1327

Large 2.9 x 4.5 cm 450-1329

Product Dimensions Order Number

Tutoplast 2 x 7 cm 93-8227

2 x 12 cm 93-8212

4 x 7 cm 93-8247

6 x 6 cm 93-8266

Testicular ReplacementMale Urinary Incontinence

Virtue® Male Sling SystemThe Coloplast Virtue® Male Sling System is designed for stress urinary incontinence (SUI) in male patients.15 Virtue utilizes a unique four-arm approach designed to provide both elevation and compression of the urethra when implanted16 and is made of 100% monofilament polypropylene.15

• Knitted monofilament polypropylene

• Bidirectional compression and elevation of the bulbous urethra with 2 transobturator arms and 2 prepubic arms

• Individually packaged

Contains:1 - Virtue Sling1 - Single-use Introducer1 - Alexis® Retractor (not shown)



Coloplast Payment Policy

Terms: Net 30 days; all items priced F.O.B. shipping point. Prices and specifications subject to change without incurring obligation.

Returned Goods Policy

Return authorization (RA) must be received from Coloplast prior to the return of merchandise. RAs are valid for 30 days from issue. Returned products must be in saleable condition with at least 1 year shelf life remaining. No credit will be issued if package integrity is broken, damaged, or defaced. All returned products are subject to Coloplast inspection. Returned products may be subject to restocking charges. Please contact Coloplast Customer Service for the full terms and conditions, and to obtain the Return Authorization. Please call (800) 258-3476 or fax (866) 216-4161.

Biological Graft Returns

1. Biologic Grafts must be stored in a clean and dry environment.

2. Temperature in storage area for Biologic Grafts must be maintained at all times between 15° C and 30° C.

3. Biologic Grafts must be kept out of direct sunlight.

4. All opened Biologic Grafts must be disposed of using Standard Practices for Handling and Disposal of Human Tissue, as determined by facility policy.

5. All Biologic Grafts must be shipped via overnight delivery.

6. No Biologic Graft shall be shipped from Coloplast to facility or from facility to Coloplast on Friday with scheduled delivery of Monday.

7. Saturday and Holiday deliveries of Biologic Grafts must be purchased with no option for return or credit.

8. Facility must obtain a Returned Goods Authorization (“RGA”) number from Coloplast before returning any Biologic Graft.

9. Biologic Grafts approved for return must be returned to Coloplast within 30 calendar days after receipt of the RGA number or no credit will be given.

10. No Biologic Graft may be returned to Coloplast with less than a 1 month expiration date.

11. In order to return Biologic Grafts, facility must complete a Return Form and attest that all requirements have been met.

Product Information Disclosure

Coloplast warrants that all products sold hereunder shall be free from defects in material and workmanship at time of delivery, subject to proper handling, transportation, storage, and use of such products. EXCEPT AS SET FORTH IN THE PRECEDING SENTENCE, THERE ARE NO EXPRESS OR IMPLIED WARRANTIES, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSE. In the event of a breach of warranty, the sole remedy available to buyer shall be replacement of the product, but only in the event Coloplast receives written notice of the defect within ten (10) days from the date defect was or should have been discovered and the nonconforming product is returned to Coloplast if so requested. IN NO EVENT SHALL COLOPLAST BE LIABLE FOR ANY INCIDENTAL, CONSEQUENTIAL, PUNITIVE OR SIMILAR DAMAGES OF ANY KIND ARISING UNDER OR IN ANY WAY RELATED TO THE SALE OF PRODUCTS HEREUNDER, WHETHER FOR BREACH OF ANY WARRANTY, FOR BREACH OR REPUDIATION OF ANY OTHER TERM, FOR NEGLIGENCE, ON THE BASIS OF STRICT LIABILITY, OR OTHERWISE. No representation or other affirmation of fact, including but not limited to statements regarding suitability for use, or performance of the product shall be deemed to be a warranty by Coloplast for any purpose.

Caution

Federal (USA) law restricts these devices to sale by or on the order of a physician.

Pricing

Coloplast reserves the right to change its prices without notice.

Ordering Information

To Order Call Toll Free 800.258.3476These products may be ordered directly from Coloplast.

TITAN®, TITAN® OTR AND TITAN® TOUCH INFLATABLE PENILE PROSTHESIS BRIEF STATEMENT

Indications: The Titan, Titan OTR and Titan Touch Inflatable Penile Prosthesis is indicated for male patients suffering from erectile dysfunction (impotence) who are candidates for implantation of a penile prosthesis.Contraindications: The Titan, Titan OTR and Titan Touch Inflatable Penile Prosthesis is contraindicated in patients with an active infection present anywhere in the body, especially urinary tract or genital infection; with a documented sensitivity to silicone; with unresolved problems affecting urination, such as an elevated residual urine volume secondary to bladder outlet obstruction or neurogenic bladder; or, unwilling to undergo any further surgery for device revision.Warnings: Implantation of the device may make latent natural erections, as well as other interventional treatment options, impossible. Men with diabetes or spinal cord injuries, as well as immunocompromised patients, may have an increased risk of infection associated with a prosthesis. Failure to evaluate and promptly treat erosion may result in a substantial worsening of the condition, leading to infection and loss of tissue. Implantation of a penile prosthesis may result in penile shortening, curvature or scarring. Pre-existing abdominal or penile scarring or contracture may make surgical implantation more complicated or impractical.Precautions: Surgeons implanting penile prostheses should be familiar with the currently available techniques for measuring the patient, determining implant size, and performing the surgery. Removal of an implanted prosthesis without timely reimplantation of a new prosthesis may complicate subsequent reimplantation or may make it impossible.Potential Complications: Potential complications include scrotal swelling, auto-inflation, discomfort, angulation/curvature, edema, device malfunction, chronic pain, difficulty with ejaculation, transient urinary retention.

The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.us.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

GENESIS® BRIEF STATEMENT

Indications: The Genesis Prosthesis is designed for the management of impotence stemming from a variety of causes, including: epispadias; pelvic fracture; spinal cord injury or disease; prostatectomy; cystectomy; abdominal-perineal resection; multiple sclerosis; diabetes mellitus; alcoholism; arteriosclerosis and hypertensive vascular disease; priapism; and Peyronie’s disease. The Prosthesis may also be used in selected patients with psychogenic impotence.

Contraindications: Implantation procedures are not advisable if infection is present anywhere in the body, especially urinary tract or genital infection. The Prosthesis should not be used in patients who have unresolved problems such as elevated residual urine from bladder outlet obstruction, or neurogenic bladder. The Prosthesis should be used with caution in diabetic patients who are more susceptible to infection and the complications of infection than nondiabetic patients. Other contraindications include unresolved urinary problems, any condition which may hamper sexual activity (such as severe angina), a history of sensitivity to foreign materials, compromised wound healing, compromised immune system, any anatomic or physiologic abnormality that could lead to significant postoperative complications, an unwillingness to undergo any further surgery for revision and psychological instability of the patient.

Warnings: Implantation of the device may eliminate any natural erections. Men with diabetes or spinal cord injuries, as well as immunocompromised patients, may have an increased risk of device infection which would necessitate an additional surgery. If a component of the device threatens to erode out the skin it must be addressed by a urologist. Failure may lead to infection and subsequent loss of penile tissue. Implantation of a penile prosthesis may result in penile shortening, curvature or scarring. Pre-existing abdominal or penile scarring or contracture may make surgical implantation more complicated or impractical. The risks and benefits of implanting this device in patients with lupus, scleroderma, myasthenia gravis, or documented sensitivity to silicone should be carefully considered.

Precautions: A thorough preoperative consultation should include a discussion between the patient and physician of all available treatment options for erectile dysfunction and their risks and benefits.

Potential Complications: Scrotal swelling, device infection, auto-inflation, discomfort, angulation/curvature, edema, device malfunction/deflation, pain, difficulty with ejaculation, transient urinary retention, fever, migration, patient dissatisfaction, , hematoma, wound opening with drainage, bleeding, delayed wound healing, decreased penile sensation, component erosion, inguinal or reservoir hernia.

See the device manual for detailed information regarding the implant procedure, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Coloplast Corp at 1-800-258-3476 and/or consult the company website at www.coloplast.us.

VIRTUE® MALE SLING SYSTEM BRIEF STATEMENT

Indications: The Coloplast Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).Contraindications: It is the responsibility of the surgeon to advise the prospective patients or their representatives, prior to surgery, of the contraindications associated with the use of this product. This product is contraindicated for patients with urinary tract infections or urinary tract obstruction; blood coagulation disorders or prescribed anticoagulation therapy; obstructive uropathy; or, are under the age of 18.Warnings and Precautions: It is the responsibility of the surgeon to advise the prospective patients or their representatives, prior to surgery, of the possible warnings associated with the use of this product.Potential Complications: As with all foreign bodies, the Virtue sling system is likely to exacerbate

any existing infection. Transitory local irritation at the wound site and a foreign body response may occur. The resulting response could lead to wound dehiscence, extrusion, erosion, inflammation or fistula formation.The following complications are known to occur with synthetic slings: • urethral erosion • infection • bladder, urethra, vessel and nerve perforation

Known risks of incontinence surgical procedures include extrusion, erosion, infection, sling migration, pain, transient or permanent retention, bladder outlet obstruction, and, continued stress urinary incontinence and persistent or new overactive bladder symptoms.

The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.us.


TOROSA® SALINE-FILLED TESTICULAR PROSTHESIS

Indication: The Coloplast TOROSA Saline-Filled Testicular Prosthesis is intended for use when cosmetic testicular replacement is indicated i.e., in the case of agenesis or following the surgical removal of a testicle.Contraindication: The implantation of testicular prostheses is contraindicated in the presence of infection or untreated neoplasm.Warnings: This device contains solid silicone elastomer. The risks and benefits of implanting this device in patients with lupus (e.g., SLE or DLE), scleroderma (e.g., progressive systemic sclerosis), myasthenia gravis, or documented sensitivity to silicone should be carefully considered. The issue of the possible relationship between silicone and various diseases has been and continues to be the subject of scientific and medical debate. Sepsis or hemorrhage may result from the placement of any foreign object in the body. Excessive fibrous capsular formation or contracture may occur around any implant placed in contact with soft tissues.Precautions: Each prosthesis should be checked for patency prior to surgery and continuously monitored throughout the surgical procedure to ensure that the structural integrity of the implant is not compromised in any way. The action of drugs (such as antimicrobials, chemotherapy agents or steroids) in contact with the prosthesis has not been tested by the manufacturer, and their use cannot be recommended. Each physician who chooses to use drugs in combination with this prosthesis must assure compatibility of the drug with silicone elastomer. A thorough preoperative consultation should include a discussion between the patient and physician of all available treatment options and their risks and benefits.Potential Complications: Potential complications include pain and discomfort.

The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to this product’s Instructions for Use. Alternatively, you may contact a Coloplast Representative at 1-800-258-3476 and/or visit the company website at www.coloplast.us.


TUTOPLAST BRIEF STATEMENT

Indications: Tutoplast Processed Pericardium is restricted to homologous use for the repair, replacement, reconstruction or augmentation of soft tissue by a qualified healthcare professional (i.e., physician). This includes grafting for horizontal and vertical soft tissue augmentation of thickness and length. The implant is provided sterile and requires rehydration prior to use.Donor Screening & Tissue Processing: The donated human tissue utilized for this implant was recovered from a donor screened for risk factors associated with infectious diseases and medical conditions that rule out donation. The donor’s blood was tested for relevant communicable diseases in a laboratory certified under the Clinical Laboratory Improvement Amendments of 1988 or equivalent, and registered with the US Food and Drug Administration for donor testing.Warnings/Precautions: The same potential medical/ surgical conditions or complications that apply to any surgical procedure may occur during or following implantation. The surgeon is responsible for informing the patient of the risks associated with their treatment and the possibility of complications or adverse reactions. As with any human tissue implant, it is not possible to guarantee freedom from transmission of infectious agents or other adverse reactions such as hypersensitivity, allergic or immune response. Prior to use, the surgeon must become familiar with the implant and the surgical procedure. Poor general medical condition or any pathology that would limit the blood supply and compromise healing should be considered when selecting patients for procedures using this implant; as such conditions may compromise outcomes. The implant should be used with caution in surgical sites where an active infection is present or in sites with poor perfusion. If the surgeon determines that the clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken. Appropriate placement and fixation of the implant are critical to success of the surgical procedure.Adverse Reactions: Possible adverse reactions include hypersensitivity, allergic or immune response. Other possible reactions include pain, infection, erosion, extrusion, exposure, contracture and procedure failure may occur. Serious adverse tissue responses or infection may require removal of implant. See the Instructions for Use for detailed information regarding the implant procedure. Warnings /precautions, adverse reactions, prior to using this product. For further information, call Coloplast Corp at 1-800-258-3476 and/or consult the company website at www.coloplast.us.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician or properly licensed practitioner.

Coloplast develops products and services that make life easier for people with very personal and private medical conditions. Working closely with the people who use our products, we create solutions that are sensitive to their special needs. We call this intimate healthcare. Our business includes ostomy care, urology and continence care, wound and skin care. We operate globally and employ more than 11,000 employees.

Coloplast Corp. Minneapolis, MN 55411 / Urology Care Surgical Support 800.258.3476

www.coloplast.us The Coloplast logo, Genesis, Titan, Torosa, Tutoplast and Virtue are registered trademarks of Coloplast A/S. Brooks is a trademark of Coloplast A/S. © 2018. Coloplast Corp. All rights reserved.

PM-01956 1.18

References1. Data on file with Coloplast.2. Wolter, C.E. & Hellstrom, H.J. (2004) The Hydrophilic-Coated Inflatable Penile Prosthesis: 1-Year Experience. Journal of Sexual Medicine, 1, 221-224. 3. Data on file with Coloplast.4. Data on file with Coloplast.5. Torosa® Saline-Filled Testicular Prostheses (2010) Instructions for Use.6. Titan®, Titan® OTR and Titan® Touch Inflatable Penile Prosthesis (2016) Instructions for Use.7. Quallich, S. A., Ohl, D.A. & Dunn, R. L. (2008). Evaluation of Three Penile Prosthesis Pump Designs in a Blinded Study of Practitioners. Urologic Nursing, 28(2), 101-108. 8. National Institute of Health. National Institute of Diabetes and Digestive and Kidney Diseases. (n.d.). Retrieved April 21, 2017, from

www.niddk.nih,gove/health-information/urologic-diseases/erectile-dysfunction. 9. Data on file with Coloplast.10. Data on file with Coloplast.11. AMS 700™ with MS Pump™ Penile Prosthesis (2016) Operating Room Manual 1004117(P/N).12. Chung, E. (2017). Penile prosthesis implant: scientific advances and technological innovations over the last four decades. Translational

Andrology and Urology, 6(1), 37-45. 13. Brooks™ Dilator Set (2014) Instructions for Use.14. Rossello Dilator Set (2012) Instructions for Use.15. Virtue® Male Sling System (2012) Instructions for Use.16. Data on file with Coloplast.17. Kogan, S. (2014). The clinical utility of testicular prosthesis placement in children with genital and testicular disorders. Translational Andrology and Urology, 3(4), 391-397. 18. Mayo Clinic. (n.d.). Peyronie’s Disease. Retrieved December 27, 2017. From www.mayoclinic.org/diseases-conditions/peyronies-disease/

symptoms-causes/syc-20353468.19. Tutoplast® Processed Pericardium (2011) Instructions for Use.20. Greenspan, D., Hernandez, R. & Faleris, J. (2008). Histology of Surgically Implanted Tutoplast Processed Dermis. 4883.

Documents

Men’s Health Product Catalog - ColoplastMD€¦ · are designed to be surgically implanted in the penis for the management ... grade stainless steel dilators; 8 mm, 9 mm, 10 mm,