Important safety information

Torosa Saline-Filled Prosthesis is a surgically implanted artificial testicle designed to replicate the size, shape, and feel of one or two testicles following surgical removal, or the absence of a testicle (agenesis) in males.

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.

The implantation of testicular prosthetic implants is contraindicated in the presence of infection or abnormal growth (neoplasm).

A testicular implant in patients with pre-existing enlargement of the scrotum (varicocele) may result in persistent pain. Due to the nature of silicone implants, testicular implants should not be considered lifetime implants and require replacement surgery over time. Torosa should typically not be implanted in patients with a documented sensitivity to silicone. These patients should discuss the risks of this implant with their physician. Patients with disorders such as lupus, scleroderma and myasthenia gravis should discuss the risks of this implant with their physician. Sepsis, hemorrhage or thrombosis may result from the placement of any foreign object in the body. An oversized implant can lead to potential complications such damage or loss of tissue (necrosis) or foreign body reaction leading to formation of blood clots (thrombosis). Excessive scarring and/or tightening around the implant (capsular formation or contracture) may occur.

Discuss all available treatment options with your doctor to understand the risks and benefits of a testicular implant.

The following device-related and procedure-related events were experienced during the clinical study for this device: discomfort/pain, swelling (edema), extrusion, displacement/migration, hematoma, abnormal tissue formation (keloid, fibrosis, granuloma), implant deflation, fluid accumulation (inguinal area), constipation, numbness/weakness (neuropathy) in legs/feet, and surgical site infection (abscess).

Resize of the implant may be elected in the future for young males implanted prior to body maturation.

This treatment is prescribed by your physician. Discuss the treatment options with your physician to understand the risks and benefits of the various options to determine if a testicular implant is right for you.

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