Medical grade silicone is available in for medical use in two forms, solid implant and
liquid injection. Each of these has limitations from the US Food and Drug Administration.
Liquid silicone is the injectable form. Its use in medicine for soft tissue
augmentation is no longer permitted in the US. It is permitted for some ophthalmic
uses. It is prohibited for soft tissue augmentation because the complication rate was
unacceptable when it was studied in the past. Liquid silicone was initially thought to
be useful when injected in microdroplets into the dermal layer of skin. Injectors of
silicone in the penis do not inject silicone into the dermal layer of the penis skin
because this layer is quite thin and microdroplet injections in this layer would not
provide any significant Girth to the penis. In my experience, it has been injected into
the Dartos layer of the penis, which has relatively loose tissue and no dermis in
which to seat the silicone. Liquid silicone acts by reacting with the body, forming
something called a foreign body granuloma. Over time, these granulomas enlarge
and become hard nodules. These nodules can be difficult to remove, They can erode
through the skin causing ulceration. More importantly, there is only one type of
liquid silicone approved for human use in the US. Some patients get injections with
non-medical grade silicone that has impurities. The body reacts to these impurities,
often causing oozing and ulceration. For these reasons, liquid silicone is not a useful
product in the long run for penis enlargement.
As a plastic surgeon, I have many years of experience managing patients who have
had silicone injected into various parts of the body and face. Many of these patients
went overseas to have injections and did not develop problems for many years.
However, once the problems occurred, they were severe and their management was
Silicone implants are the other form of silicone for human use. I have experience
with silicone breast implants, facial implants, pectoral implants, arm and calf
implants and custom implants for both cosmetic and reconstructive problems. In
general, solid silicone implants are best used in parts of the body that are static. The
penis is not the breast, the calf, or the chin. That is these are parts of the body that
do not change in the size or shape and the implant adds bulk, not function. The
penis is a unique organ. It has parts that change with sexual arousal and function, as
well as things like temperature. These functions will continue to occur with an
immobile silicone implant. So the forces exerted on the implant over time become
considerable. The device rubs against the skin, which in the penis is thin. This thin
skin is an essential part of the penis’s function and sensation. Over time, the implant
has a high incidence of erosion through the skin. Once the skin has broken down,
the implant must be removed. Skin acts as a barrier against bacterial invasion.
Silicone implants have an attraction for bacteria. This attraction is akin to a
magnetic force. Once the skin integrity is lost, the bacteria invade and adhere to the
silicone. Removal of the implant with immediate replacement will not be successful
since the bacteria in the area of the old implant will remain and will attach to the
new device. This is why any implant, whether breast, facial, calf or penis must be
removed if it is exposed. Since the history of a firm device under thin skin is that the
device will eventually become exposed, it seems more reasonable to never put the
device into the penis in the first place.
Finally, while silicone implants may be approved under something known as a 510K rule,
that is not the same as a full approval. The 510k rule states that the device is essentially
similar to another device that is already approved. That is how most silicone devices are
brought to market. The cost to achieve clearance of a device beyond a 510k rule is very
high, and beyond the reach of most small implant manufacturers. It is important to
realize, also, that I am not being critical of penile implants for the treatment of
erectile dysfunction. Those devices are not designed for cosmetic enlargement of
the penis. Those devices are for functional purposes and placed into the functional
part of the penis, not under the skin of the shaft.
Devices used for cosmetic enlargement, in my opinion as a plastic surgeon, are not
appropriate for the penis. One of the main principles of plastic surgery is to “replace
like tissue with like tissue.” There is nothing naturally in the penis that is similar to a
solid subcutaneous silicone implant. Breast implants feel like a breast. Calf implants
feel like a calf. Cosmetic penis implants feel like a silicone rubber device placed under
the skin of the penis.
In summary, silicone in its various forms is problematic for use in the penis. Based
upon my experience as a plastic surgeon in practice for 30 years and my knowledge
of injectable silicone, there is no place for this material in the penis. Subcutaneous
silicone implants are equally problematic for patients, despite the seeming
simplicity of the device. In other words, if it sounds too good to be true, it probably
is. Patients should be extremely cautious when considering silicone in their penis,
regardless of the type of silicone used.
I hope this information is helpful,
Dr. Mark Solomon
I agree with Dr Solomon,
Neither liquid (injectable) not solid (surgical implants) for the penis.