Coloplast’s patented Torosa® Saline-Filled Testicular Prosthesis aids in restoring a more natural appearance for adults and children missing one or two testicles due to congenital anorchism, monorchism, cryptorchidism, orchiectomy or other procedures. The weight, shape and soft texture are designed to mimic the natural testicles, and have high levels of patient satisfaction. (cf. 1)
Torosa® features:
Weight, shape and texture of the prosthesis approximates a normal testicle, providing a more natural looking and feeling scrotum.
Suture tab enables physicians to secure the device in a set position, if desired, minimizing unwanted implant movement within the scrotum.
Self-sealing injection port for inflation, which simplifies the surgical procedure.
Product safety:
Based on available clinical trials and published data, the prostheses have a low incidence of deflation, infection, migration, displacement, extrusion, erosion, fibrous capsular contracture, hematoma, necrosis and reoperation. (cf. 1)
There were no reports of silicone-immunological adverse events in any core clinical trial subjects. (cf. 1)
Patient satisfaction:
The cosmetic benefits provided by testicular prostheses have been reported by numerous investigators to lead to psychological benefits and high levels of patient satisfaction. (cf. 2)
Physician Videos:
Click here: http://straighttalk.net/?page_id=558 to view a collection of video clips designed to provide detailed information to physicians interested in learning more about Torosa® testicular prostheses.
Important Safety Information
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 should not be considered lifetime implants due to the inherent nature of silicone implants, implant procedures, and potential individual psychological reactions. This device contains silicone elastomer in a cured state. The risks and benefits of implanting this device in patients with lupus, scleroderma, 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, hemorrhage or thrombosis may result from the placement of any foreign object in the body. Use of an excessively large implant may result in tissue necrosis/thrombosis. Excessive fibrous capsular formation or contracture may occur around any implant placed in contact with soft tissue. The incidence and severity of this occurrence may increase if postoperative local hematoma or infection occurs.
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. Each physician who chooses to use drugs in combination with this prosthesis must assure compatibility of the drug with silicone elastomer. 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 implant or subsequent surgical procedures. Prosthesis structural integrity is required. Device should not be implanted following modification of its design. A standby device should be available during surgery. Surgeons implanting penile prostheses should be familiar with the currently available techniques for measuring the patient, determining implant size, and performing the surgery.
Potential Complications
Pain, discomfort, edema (implant or incision site), infection, extrusion, displacement/migration, genital hematoma, keloid formation, implant deflation/leakage, inadequate position, fluid accumulation, constipation, hives, fibrosis, granuloma, mobile implant, neuropathy (leg), numbness (heel), suture abscess, and unnecessary incision
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. and/or consult the company website at www.coloplast.com.
Caution: Federal law (Canada) restricts this device to sale by or on the order of a physician.
1/31/2013
References:
- Clinical data on file at Coloplast Corp., and within the device labelling.
- M1715N A Patient’s Guide to Testicular Prostheses.