Torosa® Testicular Implants

Coloplast’s patented Torosa saline-filled testicular prostheses aids in restoring the appearance in people missing one or two testicles. The weight, shape and soft texture are designed to mimic the natural testicles.

The device consists of molded silicone elastomer shell, with a self-sealing injection site located on the one end of the prosthesis. This injection site allows the implanting surgeon to fill the device with sterile, pyrogenfree 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. The device is not visible on x-ray.

Coloplast offers the only FDA-approved testicular implant for adults and children

Torosa Testicular Implants come in four available sizes: extra small, small, medium & large.

 

 

For ordering information, please call 800.258.3476.

Indication

The Coloplast Torosa 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

Implantation of a testicular prosthesis in patients with pre-existing varicoceles may result in persistent pain.  Testicular implants are not to be considered lifetime implants and therefore may require removal or replacement.  The risks and benefits of implanting this device in patients with lupus, scleroderma, myasthenia gravis, or documented sensitivity to silicone should be carefully considered.  Sepsis, hemorrhage or thrombosis may result from the implantation. Improper sizing may result in tissue necrosis/thrombosis.  Fibrous capsular formation or contracture may occur around any implant placed in contact with soft tissues.

Precautions

A thorough preoperative consultation should include a discussion between the patient and physician of all available treatment options and their risks and benefits.  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.  Careful hemostasis is important to prevent postoperative hematoma formation. Device should not be implanted until bleeding is under control. Care must be taken to avoid risk of implant puncture during procedure.

Adverse Events

Pain, discomfort, edema, infection, extrusion, displacement/migration, genital hematoma, keloid formation, implant deflation/leakage, inadequate position, fluid accumulation, constipation, hives, fibrosis, granuloma, mobile implant, neuropathy, numbness, suture abscess

See the device instructions for use for detailed information regarding the implant procedure, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Coloplast Corp  at1-800-258-3476 and/or consult the company website at www.coloplast.com.

 

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

Minneapolis, MN

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