Torosa® Saline-Filled Testicular Prosthesis

Coloplast’s Torosa® Saline-Filled Testicular Prostheses aids in creating and restoring a more natural look and feel of the testicles in the scrotum.   Multiple sizes are available to meet the needs of adult, adolescent, and pediatric patients.

 

 

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

Torosa Testicular Prosthesis 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.

Torosa is available in multiple sizes to meet the needs of adult, adolescent and pediatric patients.

For ordering information, please call 800-258-3476

1. Clinical data on file at Coloplast Corp. and within the device labeling.
2. Turek, Paul J. et al. Safety and Effectiveness of a New Saline Filled Testicular Prosthesis. J Urol. 2004; 172:1427 – 143.
3. Hayon S, Michael J, Coward R M. The Modern Testicular Prosthesis: Patient Selection and Counseling, Surgical Technique, and Outcomes. Asian J Androl 2020; 22:64-9.

Indications

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.

Contraindications

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.

Implantation of the TOROSA Saline-Filled Testicular Prosthesis may be difficult or impossible in patients with inadequate scrotal tissue to cover the prosthesis, patients who have undergone prior pelvic radiation therapy, or patients whose wound healing abilities are compromised (e.g., uncontrolled diabetes, poor circulation).

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.com.

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

Minneapolis, MN

12/04/2020

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