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The information provided is intended to be informative and educational and is not a replacement for professional medical evaluation,
advice, diagnosis or treatment by a healthcare professional.
The seamless product range of the NagorŪ smooth testicular implants is available in two options, gel-filled and elastomer.
Ovoid shaped with a choice of silicone filler developed to reproduce the consistency and feel of a natural testicle, NagorŪ
smooth testicular implants feature a low profile reinforced suture loop closely aligned to the shell for ligature fixation
in-situ or to remain flat and unobtrusive if not used.
Testicular Implants
Saline-filled testicular implants are available from Mentor for males of all ages who have lost or will lose a testicle.
Your doctor and your family members can give you advice about this implant surgery. But, the choice to get a testicular
implant is a decision that you must make. This website is designed to educate you about saline-filled testicular implants
manufactured by Mentor.
Its also intended to help you make an intelligent, informed decision. This website should not be considered a substitute
for medical advice. It is not intended to replace any discussion between you and your doctor. Our website provides you with
a solid foundation for forming questions to ask your doctor about the saline-filled implant procedure.
What factors should be considered when deciding whether to have a testicular implant?
A number of published studies have described the negative psychological effects that can result from the loss or absence
of a testicle. Various research studies show that the cosmetic benefits of saline-filled testicular implants lead to emotional
benefits and high levels of patient satisfaction.
Saline-filled 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 cases of undescended testicles, your doctor will attempt to find and remove
the undescended testicle. This will prevent the future risk of cancer of the undescended testicle.
Saline-filled testicular implants are not recommended if there is infection within the scrotum or anywhere in the body. Before
choosing to receive a testicular implant, you should speak to your doctor about your long-term expectations, and all the potential
risks and complications that can result from the procedure. Its important to know that a testicular implant is strictly for
cosmetic appearances only, and in no way functions like a natural testicle. Is there an alternative treatment?
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 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 as described above.Contraindications
There are several conditions that could increase the risk of injury from testicular implants or make device implantation difficult
or impossible. Your doctor will need to consider these conditions when decidinWhat is a testicular implant?
About the Device
The Mentor saline-filled testicular implant 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.
How the Device Works
The Mentor saline-filled testicular implant is filled by your doctor before surgery. It includes a self-sealing injection
site at one end that allows the doctor to fill the device with a sterile saline solution. On the opposite end of the implant
is a silicone elastomer tab that enables the doctor to suture and secure the implant into a set position, if this is desired.
Once the implant has been filled and sutured into place, the doctor can add more saline for a better cosmetic appearance.
Considerations
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 (see "What are the potential risks and complications?").
The long-term rates of deflation and resurgery are currently not known; however, a 5-year study is currently being done
to assess these possible problems.
Based on the information from the clinical studies of the saline-filled testicular implant, approximately 1 in 30 patients
require resurgery 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 childs other healthy testicle. In addition, infection or extrusion (when the implant shifts
and presses out through the skin) may also require additional surgery.g to implant the testicular device. These contraindications
may include infection and untreated neoplasm (cancer).How will my body react to a testicular implant?
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. If I want a testicular implant, what do I do next?
Find a urologist who you are comfortable with and who is able to answer your questions. Make sure that he or she has had
experience implanting this device. Prior to scheduling a procedure, be sure to consult with your insurance company to assure
that they will cover your testicular implant surgery.
What are the potential risks and complications?
Mentor has developed this website to give you general information. It is very important that you carefully read the following
risks and complications information, completely understand it, and discuss it with your doctor. The rates of complications
listed in this section were obtained from a clinical study of the Saline-Filled Testicular Prosthesis called the "Core
Study". This study is described in more detail in Appendix A.
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 mostly apply to silicone
gel-filled breast implants. You will be receiving saline-filled implants that contain only salt water. Certain risks that
may be associated with silicone gel will not occur with saline-filled implants. However, since both types of implants have
a silicone rubber envelope, they may be associated with certain specific risks and complications.
The known or potential risks of saline-filled testicular implants or the implant surgery are as follows
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