Testicular Prosthesis and Testicular Implants

silimedtestpros

PATIENT’S GUIDE TO TESTICULAR IMPLANTS

Bruce R. Gilbert, M.D.,Ph.D. Several studies have described the negative psychological effects of the loss or absence of a testicle. These and other studies have suggested that testicular implants (also called testicular prostheses) lead to improved body image and are associated with a high levels of patient satisfaction. I have compiled this guide to give my patients information on testicular implants. The information has been garnered from published papers, internet based research and my own experience. I have acknowledged several of these sources at the end of this guide.

    1. History
    2. The controversy behind silicone prostheses
    3. Indications for Implantation
    4. Alternatives to Implantation  of a Testicular Prosthesis
    5. Contraindications to Implantation of a Testicular Prosthesis
    6. Types of implants
      1. The Mentor Saline Filled Testicular Prosthesis
      2. Mentor Soft-Solid Testicular Prosthesis
      3. Silimed’s Silicone Elastomer Testicular Prosthesis
    7. Surgical considerations
    8. Preoperative preparation
    9. Specifics about the procedure
    10. Postoperative care
    11. Considerations about the procedure
    12. Possible side effects
    13. Patient Satisfaction with the device
      1. Safety
      2. Effectiveness
    14. What to do next?
    15. References
    16. FAQs

 HISTORY

The first report of a testicular prosthesis was by Girsdansky and Newman in 1941.  They used an ovoid Vitallium implant. Vitallium is a commonly used bioinert material which is an alloy of cobalt, chromium, and molybdenum used in dentistry and orthopedic surgery.  Their report was followed by others who have used a myriad of substances including Lucite, glass, Gellfoam, Dacron, polyethelene and silicone. The first commercially available device consisted of a silicone shell filled with silicone gel.  It was the most commonly implanted device between 1973 and 1992. A series of legislative initiates have had tremendous impact on the use of these implants.  In 1976 Congress gave the FDA the authority to regulate these devices. Devices that existed prior to the 1976 legislation were not reviewed for their safety and efficacy until additional legislation termed the Safe Medical Devices Act was enacted in 1990.  This act also mandated that manufacturers of high risk devices, such as the gel filled silicone device, keep records of the identity and address of patients implanted with these devices. Most likely due to this legislation and the controversy surrounding silicone gel leakage from breast implants, manufacturers of gel filled silicone testicular prosthesis stopped production of these devices in 1992.

THE CONTROVERSY BEHIND SILICONE PROSTHESES

First, let me point out, that there is no published data that demonstrates that silicone prosthetics cause human disease. The concern however, is whether silicone or the silicone gel that had been used in the older prosthetic devices leaks from the implant and acts as an antigen….a foreign body that activates the immune system causing an autoimmune disease.  An autoimmune disease is a disease process in which the body’s own immune system acts against itself causing inflammation and scarring in otherwise healthy tissue. What they term ‘human adjuvant disease’ includes several common disease processes of rheumatoid arthritis, scleroderma, systemic lupus erythermatosus among others. What is important to note is that all disease processes described have been associated with silicone breast implants but not silicone testicular prostheses.

INDICATIONS FOR IMPLANTATION

Testicular implants may be an appropriate choice for children with undescended testicles or torsion of the testicles. Torsion is an extreme rotation or twisting of one or both testicles that can result in damage that requires removal of the testicle. Adult males also can experience torsion in addition to other traumatic injuries or testicular cancer, all of which may require removal of a testicle. In the cases of an undescended testicles, an attempt is made to find and remove the undescended testicle.  Additionally, men that have very small, non-functioning testis may be candidates for a testicular implant.

ALTERNATIVES TO IMPLANTATION OF A TESTICULAR PROSTHESIS

Although, the testicular prostheses can create or restore a more normal cosmetic appearance of a testes-containing scrotum, the alternative to implant placement is simply no treatment. Not having treatment will require leaving a partially empty or completely empty scrotum. Another alternative (except for men with testicular cancer) is a procedure called subcapsular orchiectomy, which removes the testicle tissue from the capsule. The empty capsule is left in the scrotum. Although this tissue removal provides a smaller scrotal structure, it may be preferable to the alternative of an empty scrotum.

CONTRAINDICATIONS TO IMPLANTATION OF A TESTICULAR PROSTHESIS

There are several conditions that could increase the risk of injury from testicular implants or make device implantation difficult or impossible. These contraindications include infection and untreated cancer.  It’s important to know that a testicular implant is strictly for cosmetic appearances only, and in no way functions like a natural testicle.

TYPES OF IMPLANTS CURRENTLY AVAILABLE

There are three types of implants currently available.  However, only one, the Coloplast saline-filled testicular implant has received approval from the FDA for implantation as a testicular prosthesis. The Coloplast Soft-Solid Device is not available for implantation in the U.S.. The Silimed Oval Carving Block (Sientra Corporation) is a commonly used device in the U.S. for testicular implants although not specifically approved by the FDA as a testicular prosthesis (See product information sheet).

The Coloplast (formally Mentor) Saline Filled Testicular Prosthesis This device is about the same weight, shape and softness of a normal testicle. It comes in four sizes – extra-small, small, medium and large. The implant is made of a molded silicone elastomer shell that is approximately 0.035 inches thick. It is not visible on x-ray. The device is filled with saline at the time of surgery and just prior to implantation. It includes a self-sealing injection site at one end that allows for filling with a sterile saline solution. On the opposite end of the implant is a silicone elastomer tab that enables suturing and securing the implant into a set position, if this is desired. This device is about the same weight, shape and softness of a normal testicle. It comes in four sizes – extra-small, small, medium and large. The implant is made of a molded silicone elastomer shell that is approximately 0.035 inches thick. It is not visible on x-ray. The device is filled with saline at the time of surgery and just prior to implantation. It includes a self-sealing injection site at one end that allows for filling with a sterile saline solution. On the opposite end of the implant is a silicone elastomer tab that enables suturing and securing the implant into a set position, if this is desired.

The Coloplast (formally Mentor) Soft-Solid Testicular Prosthesis The Soft Solid Testicular Prosthesis is not available in the United States.  It has not received FDA approval. It is only available in certain countries outside the US. The SSTP is made in five sizes: Extra-small, Small, Medium, Large, Extra-large. The device consists of a molded silicone elastomer shell,ranging from 0.012 – 0.018 inches thick, filled with cured siliconeelastomer. A silicone elastomer Dacron reinforced patch for suturingthe prosthesis in position is located at one end of the device shell.Coloplast had conducted a clinical study to evaluate the safety and effectiveness of a Soft-Solid Testicular Prosthesis (SSTP). In this nationwide study, 60 patients were enrolled in 10 study sites were implanted with a Mentor Soft-Solid Testicular Prosthesis and followed for 1 year. The Coloplast Soft-Solid Testicular Prosthesis is indicated for cosmetic testicular replacement when the natural testicle has been removed. The weight, shape, and texture of Mentor soft-solid testicular implants is designed to approximate normal testicles, providing patients with a more natural looking and feeling scrotum. They are intended to aid in the restoration of a normal physical appearance for male patients of all ages with one or more missing testicles.

Sientra’s (formally Silimed) Silicone Elastomer Implant aka Oval Carving Block The Sientra’s oval carving block is composed of an envelope made of chemically and mechanically resistant silicone elastomer which is thin, soft, smooth of surface and contains a certain amount of elastomer whose shape, density and overall consistency have been chosen to make it as similar as possible to the shape and feeling of the human testis it replaces.  All materials used are medical grade and proven to be biocompatible (is safe and tolerated well by the body). The silicone envelope membrane is made of a compound of dimethyl polysiloxane and dimethyl fluoro silicone copolymer.  The silicone envelope is filled with an elastomer mixture of reinforced dimethyl methylvinyl siloxanes with reinforced dimethyl methylhydrogen siloxanes. Applied Silicone Corporation manufactures the material. Silimed’s oval carving block Silicone Implant are available in 5 sizes. Sientra’s oval carving block implant is pending approval by the FDA.

SURGICAL CONSIDERATIONS

Testicular surgery requires an incision. As with any surgical procedure, there are risks such as infection, delayed wound healing, fluid collection, hematoma formation (a collection of blood inside the body in and around where the incision is made), bleeding and possible reactions from anesthesia. These complications are uncommon. Small areas of fluid collection and small hematomas will be absorbed by your body. In addition to these known risks, there are unanswered questions about silicone implants, which, as previously discussed, mostly apply to silicone gel-filled breast implants. Certain risks that may be associated with silicone gel will not occur with the newer devices including the saline-filled, soft-solid or silicone elastomer devices. However, since all types of currently available implants have a silicone rubber envelope, they may be associated with certain specific risks and complications. There are several different accepted surgical approaches that can be used to insert your testicular implant. I will discuss with you the method that would be most appropriate choice for your individual case. It is important to know that implantation of a testicular prosthesis may not be a one-time procedure. Any complications from your surgery may require further procedures.

PREOPERATIVE PREPARATION

For any elective surgery you should be in the best of health. It is important to let my office know if you have any other health problems which might necessitate consultation with an internist prior to your surgery. Also you should avoid aspirin and aspirin like products (e.g. ibuprofen) and stop all herbal supplement for a week before your surgery. The week before surgery you will be asked to report to the Ambulatory Surgical Center at which time a medical history, complete examination and necessary laboratory tests will be performed by staff of the Surgery Center. Testicular implant surgery is usually performed on an outpatient basis (no overnight stay).  However, for those patients with significant underlying medical problems, a brief hospital stay might be required. I will discuss with you at your consultation which approach is best suited for you.

SPECIFICS ABOUT THE PROCEDURE

On the day of your surgery, you will be asked to report to the Ambulatory Surgical Center at least one hour before surgery and must be accompanied by someone capable of driving you home. You will not have eaten nor drunk anything since dinner the night before. I will meet with you during the hour prior to surgery to examine you and answer any questions. Your procedure will usually take between 30 and 60 minutes. The procedure is performed under either a local, general or a spinal anesthetic, all of which are extremely safe and effective. These options will be discussed in detail with you by the anesthesiologist prior to the procedure. You will usually remain in the recovery room for a minimum of one hour and as long as you need until you feel comfortably alert for travel.

POSTOPERATIVE CARE

Most patients experience some discomfort during the first 24 to 48 hours after your procedure. I will prescribe painkillers to take if needed. You’ll probably be instructed to keep your surgical bandages on your scrotum for at least a few days. Most likely you will feel fatigued and your scrotum will be swollen, tender and sensitive to physical contact for some time. However, your ability to urinate should not be affected. Although every person’s recovery time is different, you should be able to resume most of your daily activities within a week to ten days. Remember to be patient, and try not to rush your recovery time. Should any problems occur after your procedure, immediately contact me. This is especially important if you have a high temperature, or if your scrotum becomes excessively swollen (enlarged beyond its normal size), painful, red or inflamed. (Please click here for specific postoperative instructions)

CONSIDERATIONS ABOUT THE PROCEDURE

You should know that testicular implants, like other medical implant devices, should not be considered lifetime devices. There is the chance, though minimal, that the body could have an adverse reaction to the implant, or that the implant may either rupture or leak (or both). These will require the implant to be removed. The long-term rates of deflation when the saline-filled is utilized and re-surgery are currently not known; however, long term studies are presently underway to access these issues. Based on the information from the clinical studies of Mentor’s saline-filled testicular implant, approximately 1 in 30 patients require re-surgery within the first year to either remove or adjust the implant. Testicular implants placed in a small child may need to be replaced by a larger implant as the child matures and grows, if the child or his parents wish to maintain a size that closely matches the child’s other healthy testicle. In addition, infection or extrusion (when the implant shifts and presses out through the skin) may also require additional surgery.

POSSIBLE SIDE EFFECTS

The following is an overview of potential side effects of implantation of a testicular prosthesis. Although rare, you should be aware that these adverse effects can occur. These will be discussed with you in detail at the time of your initial consultation. A body’s natural response to any implanted object is to reject it. The body’s rejection response depends in part on the biocompatibility of the materials that make up the implanted device. Biocompatibility is the ability of an object or substance to blend with the body’s natural tissues without creating a harmful response. The more biocompatible a material is, the less the body will reject it. Scientists are continually seeking new materials that are more biocompatible. The most common biocompatible material available today for testicular implants is silicone, which is used in many medical and consumer products. As a natural reaction to any device placed in the body, scar tissue may form around a testicular implant. This is called a capsule. In some men, the capsule can contract, causing a condition known as fibrous capsular contracture. This can result in a hardening of the testicular implant, which may cause discomfort or pain. Fortunately, medical research has shown incidences of fibrous capsular contracture to be low in testicular implant cases.

PATIENT SATISFACTION WITH THE DEVICE

The only data currently available that defines patient satisfaction with a testicular prosthesis is for the Coloplast (formally Mentor) saline filled device. It is the only device currently approved by the FDA for implantation and therefore the only device required to have this type of testing performed. In the premarket study the following data was reported:

Safety

The main complications noted in these studies were as follows:

  • Pain and/or discomfort occurred in approximately 10% of patients.
  • Temporary swelling at the implant site in approximately 3% of patients.
  • Extrusion of the implant in approximately 2% of the patients.
  • Infection at the implant site in approximately 1% of patients.
  • Displacement/migration of the implant in approximately 2% of patients.

Approximately 1 in 30 patients required re-surgery within 1 year after device implantation in these studies, usually to remove the implant. The most common reason for implant removal was extrusion of the implant.

Effectiveness

The effectiveness of the implant is based on the following results:

  • Physician measurements documented that the implanted device adequately mimics the size of the natural testicle.
  • The cosmetic appearance and firmness of the implanted device was rated as normal by physicians.
  • Using standardized questionnaires, patients recorded high levels of satisfaction with the implant, as well as increased levels of how they viewed their body in sexual activities. Additionally, there was no decline in either self-esteem or body esteem, as assessed using the Rosenberg Self-Esteem Scale and the Body Esteem Scale.

WHAT TO DO NEXT?

If you feel a testicular implant is something you would like to explore further please give us a call to make an appointment. I will first ask that you complete questionnaires about your health history.  I will then examine you, obtain a urine sample for testing, review the procedure as well as show you all the implants currently available.  We will then discuss the differences between them. During the hour or more that we spend together there will be plenty of time to have your questions answered and obtain the information you need to make a decision as to whether the procedure is right for you and as to which prosthesis is best for you. I have many patients that are from another state or another country.  I have found that it is most convenient for the patient to arrange for the consultation on the day prior to the scheduled procedure. In order to schedule the consultation (and procedure) I will need to have the questionnaires completed and reviewed by me prior to scheduling a consultation/procedure. This allows time for any additional testing that might be needed, to be completed in a timely fashion. Return to Top

REFERENCES

  1. Girsdansky, J and Newman, HF,Use of a vitallium testicular implant, Am J Surg,53:514, 1941; First report of a testicular implant
  2. Bukowski, TP, “Testicular Prostheses”, Chapter 8 in “Urologic Prostheses: The Complete Practical Guide to Devices, Their Implantation, and Patient Follow up, Culley C. Carson III, MD editor, Humana Press, Totowa, New Jersey, 2002

FAQ

Q1. Can someone who is unhappy with the size of their testicle get the surgery or do they need to have lost it? A1. Most commonly a testicular implant is placed due to loss of a testis from trauma, removal of testis due to disease, or absence of a testis since birth. Less commonly, the presence of a small testis which is either acquired (e.g. due to infection) or congenital (i.e. present since birth) brings the patient into my office. Although the presence of a small testis is not an absolute contraindication for implantation, these cases require a detailed discussion with the patient. Some of the items that need to be discussed prior to the surgeon and patient considering surgery include: • Is the remaining testis functional? If not consideration to removing it at the time of implantation should be considered. If the remaining testicular tissue is to be left in place a discussion with the patient about the potential for discomfort from the implant pressing against the remaining testis and the potential for the remaining testis to displace the testis (usually higher) in the scrotum giving a less than ideal cosmetic result. • Patient expectations: What the patient’s main goals are in having the surgery need to be addressed. For example, I have had patients, with absolutely normal size testes, request implantation of a prosthetic testis to make the scrotum “bigger”. This is not an appropriate indication. ….the bottom line….although not an absolute contraindication for implantation several issues need to be addressed by examination of the patient and discussion of the patient’s expectations prior to considering implantation of a testicular prosthetic device in a scrotum with testicular tissue present.

© BR Gilbert MD,PhD,PC If you would like more information please contact Bruce R.Gilbert, M.D., Ph.D. at 516-487-2700 or info@BruceGilbertMD.com .