An artificial testis, often called a testis prosthesis (also referred to as “prosthetic testicle” or “testicular implants”), 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 and only testis prosthesis ever approved by the FDA for use in the U.S.
To learn more about testis prosthesis, please select one of the following topics. If you are ready to schedule a consultation, contact us now.
History of Testis Prosthesis (“Testicular Implants”)
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.
The Controversy of Testis Prosthesis
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.
FDA Testis Prosthesis Announcement, 1993
The Food and Drug Administration (FDA) today proposed that manufacturers of testicular implants be required to submit scientific data to show that these products are safe and effective.
Testicular implants, which are made of silicone, are intended for cosmetic purposes. They are commonly used to correct congenital abnormalities in infants and toddlers who are born without one or both testicles. They are also used in men who have had one or both testicles removed because of cancer or other diseases or who have lost one or both testicles due to injury. An estimated 1,000 are implanted yearly.
“We need to make sure these devices are safe and effective,” said FDA Commissioner David A. Kessler, M.D. “Therefore, we are proposing that companies submit data, just as we did for breast implants.”
Testicular implants are pouches that are placed in the scrotum. They are made of solid or gel silicone and have a silicone covering. Some types are coated with polyurethane foam.
These implants were on the market prior to the Medical Device Amendments of 1976, which gave FDA regulatory authority over devices. Like other pre-amendment devices, testicular implants were allowed, under the law, to remain on the market with the understanding that FDA would later require manufacturers to demonstrate their safety and effectiveness.
Although some information on the risks and benefits of testicular implants is available, there is not enough scientific evidence to determine whether the benefits outweigh the risks.
The agency’s safety concerns regarding the implants involve the lack of adequate information in these areas:
- The incidence of leakage, hardening of surrounding tissue and rupture. The silicone gel in these implants may leak into adjacent tissue, causing problems similar to those seen with breast implants.
- The long-term effectiveness of the implants. Reported problems of unknown frequency and origin include infection, pain, discomfort, erosion of the device and its migration to other parts of the scrotum and abdomen. It is also not known how often these complications require corrective surgery.
- The protential for long-term adverse effects, such as cancer, immune-related connective tissue disorders and reproductive problems. This type of information is particularly important because many of the implant users are young.
- The immediate and long-term psychological benefits of the implants, such as patient satisfaction and improved self-image and psychological outlook.
If today’s proposal is made final, manufacturers planning to continue marketing testicular implants will be required to submit a Premarket Approval Application demonstrating the safety and effectiveness of these products as a condition for keeping them on the market.
FDA’s call for safety and effectiveness data on testicular implants is part of the agency’s ongoing review of pre-1976 devices. In addition to requiring safety and effectiveness data on silicone gel breast implants, FDA recently proposed calling for safety and effectiveness data on saline breast implants and will soon do the same for inflatable penile implants, heart bypass blood pumps and cranial electro-therapy stimulators.
Today’s proposal, which is being published in the Jan. 13 Federal Register, provides fo ra 60-day comment period. Comments may be submitted to Dockets Management Branch, HFA-305, Rm 1-23, 12420 Parklawn Dr., Rockville, Md. 20857.
FDA is one of the eight Public Health Service agencies within the U.S.Department of Health and Human Services.
Dr. Turek’s Research in 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.
Available Testis Prosthesis
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.
Are You a Candidate for Testis Prosthesis?
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.
The Testis Prosthesis Procedure
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.
Testis Prosthesis Patient Instructions
The following is an outline of the what to expect and do before and after the procedure:
The Consultation Visit
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:
Dr. Turek will ask you questions about the kinds of symptoms you are having and also ask questions about your medical history.
Dr. Turek will perform a limited and very brief physical examination on you to assess you anatomy and to determine your candidacy for the procedure. Issues he will consider are the scrotal anatomy, the size of the opposite testis and optimal placement of an incision.
Dr. Turek will then discuss the options for testis prosthesis placement, including benefits and risks, so that you have a good idea of what the procedure involves, the recovery afterward, when you can resume your normal activities.
If, after meeting with Dr. Turek, you would like to have him do the procedure, you can either schedule your appointment before you leave that day or contact us at 415-392-3200 (San Francisco) or 310-499-9299 (Los Angeles) when you decide to have it in the future.
We would like you to ask questions at this visit or afterwards to ensure that you are completely comfortable with what is planned.
Eat normally the night before surgery, but follow the directions that anesthesia recommends for the morning of surgery. If no specific directions are given, withhold all food and drink after midnight and on the morning of surgery.
Do not take any aspirin, or any ibuprofen containing medications (Advil, Motrin, Aleve) at least 10 days prior to the procedure, as these medications have a side effect that can reducing platelet function and therefore lower blood clotting ability.
Someone will need to drive you home or to your hotel after the procedure, following your recovery from the procedure. Buy some frozen peas or mixed vegetable bags from the grocery to use as a cold “sandbag” to the area after the procedure.
Please call the clinic at 415-392-3200 (San Francisco) or 310-499-9299 (Los Angeles) to schedule an appointment to see Dr. Turek in 1-2 weeks for a quick postoperative check if you are in town.
Regarding diet, start with clear liquids or something light and then progress to your normal diet.
You should rest for the first 24 hours following the procedure to lessen the chance of swelling. Avoid strenuous exercise (including sex) or heavy lifting for 7 days. After that, you can do all of your normal activities, but at the start, let discomfort be your guide: if it feels uncomfortable, slow down.
Apply ice packs (frozen peas or mixed vegetables work well) to the groin area over the covered area for 24 hours to help with swelling.
If your job involves deskwork or very light activity, you may return to work 2 or 3 days after surgery. Remember that it is likely that you will have some discomfort for the first few days after surgery when deciding when to go back to work.
Shower daily, but do not soak in a bath for at least 5 days. The sutures are buried under the skin and are self-absorbing and do not need to be removed.
Take your prescribed pain medicine, usually Vicodin, for moderate discomfort. Always take the Vicodin with food in your stomach, so that you do not get nauseated. You can take Tylenol or Ibuprofen for mild discomfort.
When taking pain medication, be careful as you walk or climb stairs, as your judgment can be impaired. Dizziness is also not unusual.
Do not make important decisions until the next day as some anesthetics have a delayed metabolism and can interfere with the ability to perform these tasks.
- Avoid alcoholic beverages for 24 hours.
- Do not drive or operate heavy machinery for 48 hours.
- Do not eat heavy or large meals until the next day, as a heavy meal may be difficult to digest. Spicy and greasy foods should be avoided.
Problems to Report
Problems you should report to your doctor if they occur:
- Fever > 101º F, shaking and chills.
- Nausea and vomiting.
- 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.
- Drug reactions such as hives, rash, nausea or vomiting.
- 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 the clinic nearest you at 415-392-3200 (San Francisco) or 310-499-9299 (Los Angeles). For evening/weekends you can use the same numbers.