Testis Prosthesis, Artificial Testis and Testis Implants

For a variety of reasons, in both children and adults, a testis can be missing or removed. This can happen from surgery for cancer, accidental injury, twisting or lack of development of a normal testis. An artificial testis, often called a testis prosthesis, can be implanted to restore the normal appearance of the scrotum and to hopefully restore quality of life. Dr. Turek helped develop and study the first testis and only prosthesis ever approved by the FDA for use in the U.S.

Testicular prostheses have been used for 50 years to replace missing or removed testes. The first prosthetic device was implanted in 1939 and used a metal alloy called Vitallium. Since then a variety of different materials have been used, including glass spheres, lucite, methacrylate, and polyurethane foam. In 1973, a dramatic improvement in prosthetic design occurred with the development of a silicone gel-filled, silicone rubber prosthesis. This design was similar to that used for breast implants around the same time. In 1995, the manufacture of the silicone gel-filled testis prostheses in the U.S. was discontinued because of concern about the safety profiles of other kinds of implants, including breast implants. This stemmed from an association of silicone implants with the development of connective tissue disease. Subsequently, panels of expert in the U.S. and Britain failed to find evidence of a real linkage between these medical conditions and the use of implants. Finally, in 1997 Dr. Turek led the medical and scientific team that developed and studied the first formally FDA approved testis implant. In a large series of patients, he showed that a salt water filled, silicone shell prosthesis was not linked to the development of connective tissue disease or cancer. This prosthesis is currently the most widely used in many countries around the world.

What was the controversy that led to testis prostheses
being pulled off the market in the past?

Leading up to 1995, there were several legal cases initiated by patients claiming that leaking breast implants could lead to the development of autoimmune disorders or even cancer. Autoimmune disorders are also called connective tissue diseases and involve the body reacting against itself and causing problems such as chronic joint pain, hardening of the skin and organ malfunction, among others. The reason testis implants were pulled off the market by the manufacturer was that these devices were of similar design to the breast implants that were implicated in disease development, and there was concern that they may also be associated with autoimmune disease if they were to leak. Since then, the association between implants and autoimmune disorders or cancer has been disproved but makers of testis prostheses were reluctant to put devices back on the market as the FDA now asked for proof that the devices were safe and effective before they were put on the market. With the rise in patient interest for these implants, research studies were undertaken on breast, testis and other implants to demonstrate their safety and effectiveness to the FDA. Dr. Turek directed the FDA study that led to FDA approval of the only testis prosthesis to date and the most widely used device today.

What did Dr. Turek’s published study show about the risks and
benefits of a testis prosthesis?

Dr. Turek led an open label, 5 –year, multicenter, prospective, case-controlled clinical trial of testis prostheses in 18 centers across the U.S. Both men and boys patients missing one or both testis and having not active cancer or autoimmune disease were enrolled. All patients had formal autoimmune and urologic evaluation before and after the prosthesis was placed. Adverse events and effectiveness were carefully assessed in all patients. In addition, other secondary outcome measures assessed were quality of life assessments with 3 validated psychological instruments. All patients were followed for at least one year.

Among 149 patients who completed the study, no patient noted any symptoms of autoimmune disease during the study. In addition, the scores on 2 of 3 validated, psychological quality of life instruments were stable or improved significantly (e.g. the Body Esteem Scale, and the Body Exposure in Sexual Activities Questionnaire) after the prosthesis was placed. Major complications included device extrusion (rejection by the body) in 2% of patients and device migration 0.7% of patients. The reoperation rate was 2% for these issues. Minor complications, managed without further procedures, included discomfort or pain (9% overall, but only 2% was deemed device-related pain), allergies or sinusitis (5%), scrotal swelling (3%) and hematoma, numbness, keloid, mild migration (1% each) From these findings, the study concluded that the salt-water filled, testis prosthesis is safe and well tolerated. In addition, for the first time in the history of testis implants, the study showed that by validated self-esteem measures, there is an improvement in quality of life in men who receive such implants.

Currently, one FDA-approved testis prosthesis is available to use and has been on the market since 2002, after Dr. Turek and his colleagues finished a nationwide study in hundreds of boys and men showing that the device is safe and effective. This implant is a silicone shell, salt water-filled device that comes in 4 sizes (see Figures 1 and 2).

The implant is made of a molded shell of silicone elastomer less than 5/100 of an inch thick and that is not visible on x-ray. The implant is filled with salt water at the time of placement and has a self-sealing injection port at one end for filling and small silicone tab at the other end to secure the implant into a set position in the scrotum, if needed.

Several other implantable devices are available under as part of ongoing studies, but they are not approved by the FDA for use as testicular implants.

The study that Dr. Turek directed concluded that testis implants are important not only for cosmetic reasons but can also improve a man’s quality if life. Men who have torsion or twisting of a testis, testis cancer or a traumatic injury, may all require removal of the affected testicle. A testis prosthesis can restore the look and well being of men affected by these conditions. Testicular implants may also be an appropriate choice for children born with undescended testicles or torsion. For most undescended testicles, attempts are made find and lower it into the scrotum, but occasionally this is not possible and the undescended testicle is removed to prevent the later development of testis cancer. Finally, men who have small, non-functioning testes may also be candidates for an implant. Importantly, an implant should not be placed in the setting of infection or untreated cancer. The alternative treatment to placement of a testis implant is not to place it and receive no treatment. Please remember that a testis implant in no way functions like a natural testicle as it does not make sperm or male hormone.

Testis prostheses are placed in a small surgical procedure that takes 30-60 minutes under anesthesia and is performed on a come and go basis. Patients receive intravenous antibiotics and a thorough skin preparation before the procedure. A small incision can be made either in the scrotum or in the groin to place the device. Dr. Turek prefers a muscle sparing upper scrotal incision that allows for an entry site that is distant from the final resting position of the prosthesis. After the incision, a scrotal pouch is created and a suture can be used to fix the prosthesis (through the suture tab) in a dependent position in the scrotum. The prosthetic is bathed in antibiotic solution, filled with salt water, placed in the scrotum and examined for overall suitability and for good position. The incision is closed in multiple, non-overlapping layers after antibiotic irrigation. Patients are then discharged with several days of oral antibiotics and followed up carefully over the next 3 months.

In addition to the complication rates observed in Dr. Turek’s study mentioned above, other issues should be considered before the decision is made to receive a testis implant. Like any other medical implant, testis implants should not be considered lifetime devices. There is a small risk that the body may try to reject or extrude the device or that the device could leak or rupture, all of which will require that the implant be removed. In addition, the long-term rate of deflation of saline within the device is still unclear. Furthermore, about 1 in 40 patients will need another surgical procedure within the first year to either remove or adjust the implant. In children, a smaller implant will likely need to be replaced by a larger implant as the child grows. Finally, the body’s natural reaction to any device within it is to form scar tissue around it. This is called a capsule and, although rare, it can occur with testis implants too. In some men, this may cause a hardening of the implant, leading to discomfort, pain or decreased satisfaction.

What should I think about regarding the planning
and recovery from this procedure?

The following is an outline of the what to expect and do before and after the procedure:

This visit is important for you to meet and feel comfortable with Dr. Turek, to figure out whether you are a good candidate for a testis prosthesis, and to discuss the benefits and risks of having such a procedure. At this visit:

Please call Dr. Turek’s nurse Paula at 415-392-3200 to schedule an appointment to see Dr. Turek in 1-2 weeks for a quick postoperative check if you are in town.

3. Expect a small amount of bloody discharge from the incision. However, call us if it continues and the incision site becomes red, painful or separates.

5. You may get black and blue around the incision site and also in scrotum and on the penis. If the amount of swelling concerns you, please call the office.

If you have any further questions please call Paula Chavez at 415-392-3200. For evening/weekends please call 415-392-3200.