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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.
Calcium Deposits:
Any surgery or injury to the testicle can produce small spots of calcium in the testicle(s) that can be seen on x-rays.
These deposits may not occur until years after implant surgery. They are benign (non-cancerous) and cause no problems but
must be differentiated from the calcium that is often seen in testicular cancers. A biopsy may be necessary to make this distinction.
Deflation/Rupture of the Implant:
Causes of rupture and/or deflation of implants include, but are not limited to, the following events (this was reported
in 0.7% of the Core Study patients):
* damage to implant prior or during surgery such as abrasion to the shell, overfilling the implant or from surgical
instruments;
* postoperative trauma that may occur during activities such as bicycle riding, contact sports, manual massage, intimate
physical contact and any other activity that may put stress on the groin area; or
* damage from unknown causes.
Discomfort/Pain:
An uncomfortable feeling around the area of operation that is normally associated with surgery, and usually goes away.
The length of time of this discomfort or pain should be discussed with your doctor or surgeon (discomfort was reported in
4.0%, and pain was reported in 5.4% of the Core Study patients).
Displacement/Migration/Shifting of the Implant:
The movement of the device from its originally implanted position. This occurred in approximately 2% of the patients in
the clinical study.
Dissatisfaction with Cosmetic Results:
Incorrect implant size or migration (movement of implant from original position) of implants may interfere with a satisfactory
cosmetic result.
Extrusion of Implant/Interruption of Wound Healing:
Extrusion is when the implant shifts and presses out through the skin (this was reported in 2.0% of the Core Study patients).
In addition, skin damage, sloughing (shedding of dead skin) or wound separation may result from:
* tight pull of skin over the implant,
* trauma to the skin during the surgery, or
* not enough tissue to cover the implant; this may block the blood circulation.
Fluid Collection:
A natural process where excessive fluid accumulates around the implant after, and as a result of, your surgery (this was
reported in 0.7% of the Core Study patients).
Hardening of Testicular Implant:
This can occur as a result of the body's natural reaction to a device placed in the body. It is caused by the formation
and contraction of scar tissue around the implant. The implant may be difficult to remove if the degree of scar tissue is
significant.
Hematoma:
Hematomas are a collection of blood, usually a clot, that occurs in tissue due to a break in a blood vessel. Large hematomas,
manifested by enlargement, tenderness and discoloration of tissue may, if untreated, lead to extrusion of the implant (this
was reported in 1.3% of the Core Study patients).
Hemorrhage:
Bleeding due to a cut or scratch. This is related to the surgical procedure.
Infection:
Infection, manifested by swelling, tenderness, pain and fever, may appear in the immediate postoperative period or at
any time after insertion of the implant. If an infection does not clear up promptly with proper treatment, your surgeon may
have to remove your implant.
Irritation:
Some materials in this device have been shown, during animal studies, to be irritants. It is possible that you may experience
some irritation from this testicular implant.
Keloid:
A thick scar that results from excessive growth of fibrous tissue (this was reported in 1.3% of the Core Study patients).
Necrosis:
Necrosis is the death of tissue cells and may lead to implant extrusion.
Numbness:
A lack of feeling or sensation in the lower part of the body caused by the surgery and not the presence of the implant
(this was reported in 0.7% of the Core Study patients)
Overfilling of Implants:
When more than the recommended volume of saline is injected into the implant.
Scarring:
A mark left by healing of damaged tissue.
Sepsis:
The spread of bacteria from the original site of infection.
Swollen Lymph Nodes:
Lymph nodes are the normal way the body removes certain kinds of waste from its system. When this process takes place,
the lymph nodes can appear swollen. As the nodes drain, the swelling will eventually go away, signaling that the waste (dead
cells mixed with water) is being removed from the body.
Thrombosis:
The formation or development of a blood clot within a blood vein. This is related to the surgical procedure.
Other:
The long-term effects of this device have not been clearly established in animal studies and therefore are not fully known.
The theoretical risks of silicone are:
Allergies:
The body's natural reaction to the presence of material not normally present in the body. This can take the form of sneezing,
coughing, itching, skin rashes, etc.
Biocompatibility:
Reports in the medical literature suggest that biocompatibility responses may be affected by different biomedical materials,
such as silicone.
Birth Defects:
Preliminary animal studies show no evidence that silicone testicular implants would cause birth defects to any future
children parented by a recipient of this device. However, to rule out that possibility for humans, further scientific studies
are necessary to show whether or not testicular implants are associated with birth defects.
Cancer:
There is presently no established scientific evidence that links silicone testicular or breast implants with cancer. However,
the possibility cannot be ruled out.
Connective Tissue Disorders:
There have been reports describing an association between certain silicone-based products and certain connective tissue
disorders. These are a group of disorders in which the body reacts to its own tissue as though it were foreign material. These
disorders can cause long-term, serious, disabling health problems. Symptoms may include pain and swelling of joints, tightness,
redness or swelling of the skin, swollen glands or lymph nodes, unusual and unexplained fatigue, swelling of the hands and
feet and unusual hair loss. Generally, people who have these relatively rare connective tissue disorders experience a combination
of these and other symptoms.
Some cases of these disorders have been reported in women with breast implants. Some of these women have reported a reduction
in symptoms after their implants were removed. Manufacturers are sponsoring large-scale scientific studies to explore whether
a possible link exists between silicone breast implants and connective tissue disorders. To date, however, there is no evidence
that these disorders occur more often in women who have silicone breast implants when matched to women of similar ages.
Degradation and Particle Shedding:
The medical literature suggests that degradation and particle shedding (harmless, microscopic [very small], silicone particles
dislodged from the surface of the implant due to rubbing) of a silicone elastomer shell, such as that used for the saline-filled
testicular implant, may occur in the capsule that normally develops around the implant and in draining lymph nodes. Further
research is being undertaken to determine the effects of degradation and the possibility of toxicity.
Neurological Symptoms:
There have been some reports of patients experiencing neurological symptoms at variable times after breast implant surgery.
Some of the complaints have involved difficulties with vision, sensation, muscle strength, walking and balance. These reports
do not prove a link between the implants and neurological problems.
Your doctor will discuss any additional information about the risks of saline-filled testicular implants and your surgical
procedure. Testicular implants are not considered to be lifetime implants. The expected life of the implant is unknown. You
are encouraged to read the Product Insert Data Sheet, which will be provided to you by your doctor.
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