Summary: The Hidden Dangers of Silicone Injections Marketed as “Pharmaceutical Grade” Penile Fillers
- At Rejuvall, we specialize in the surgical removal and repair of penile and scrotal damage caused by silicone injections.
- Non-surgical penile enlargement procedures marketed as “pharmaceutical grade silicone” or “collagen-inducing” often contain liquid silicone, not FDA-approved fillers.
- The FDA classifies silicone oil derivatives injected in excess of 5 mg as a medical device, NOT a dermal filler. It’s not a penis filler. It’s simply a dangerous health hazard.
- These injections are falsely advertised as natural, permanent, and minimally invasive, leading men to believe they are far safer than they are.
- Liquid injectable silicone (LIS) is linked to serious long-term complications:
- Chronic inflammation and granulomas
- Autoimmune disorders
- Lymphedema and blocked lymphatic drainage
- Skin thickening, migration, and permanent deformity
- 99% patient’s we’ve treated / repaired state they were never told they were receiving silicone oil. They understood it was injections that triggered production of their own collagen and that’s how the increased size would occur
- , and many report no informed consent about the risks.
- Patients report shock when they discover some of these clinics operate without malpractice insurance or use compounding pharmacies to mix and administer illegal formulations.
- Timely medical evaluation is essential to reduce risks and prevent life-altering complications.
Minimally Invasive Permanent Filler Penile Thickening Is Hazardous
A dangerous form of non-surgical penile enhancement has been gaining traction under various names—“permanent filler,” “collagen-inducing injection,” and more recently, “pharmaceutical grade silicone.”
While opinions may vary on the safety of some male enhancement techniques, there is overwhelming consensus across the medical community that injecting large volumes of silicone into the penis is unsafe, unethical, and medically irresponsible.
Some providers attempt to legitimize this practice by using misleading terms like “pharmaceutical grade” or “medical grade dimethicone,” but make no mistake—injecting more than a couple of mL’s is silicone oil is not FDA-approved for injection into human tissue, and its long-term health risks are well documented.
We expect this issue will eventually be addressed by the criminal enforcement division of the FDA and the courts. But until then, more men are being harmed every day by clinics putting profit over patient safety.
Penis Enlargements From Injected Silicone Oil
We’ve witnessed a sharp rise in patients seeking repair and even life-saving procedures after undergoing so-called non-surgical penile enlargement procedures promoted as “natural” or “collagen-inducing.” These treatments are marketed as a way to trigger the body’s own collagen production, resulting in a permanent increase in girth.
But in reality, these clinics are injecting large amounts of liquid silicone—a substance the FDA has deemed unsafe and explicitly warned against for use in soft tissue enhancement.
To make the procedure sound more legitimate, some providers now refer to the material as “pharmaceutical grade silicone” or “medical-grade dimethicone,” misleading patients into believing it is both approved and biologically compatible. It is neither.
Silicone oil is simply a cheaper alternative to FDA-approved dermal fillers like hyaluronic acid, and its use is often driven by one thing: higher profit that can be invested into marketing to perpetuate the misleading double-talk and line the pockets of some doctors. The long-term risks to the patient are rarely disclosed—and in many cases, not even understood—until the damage is done.
And according to a number of patient’s we’ve treated: that’s when the “collagen doctors” would no longer return their desperate phone calls.
What is "minimally invasive permanent penile thickening"?
This procedure is often marketed as a “minimally invasive permanent” thickening technique for the penile shaft, glans, and scrotum.
Patients report being told they’re receiving a:
"collagen layering activation filler material, positioned directly below the penile epidermis. Following insertion of the material, the body will be prompted to generate collagen. This collagen is permanent and natural.”
But in case after case, we’ve discovered the material injected was not a collagen stimulator at all—it was simply liquid silicone, often misrepresented as “pharmaceutical grade” or CMC-enhanced filler. These misleading terms are used to avoid triggering patient concerns and to make the injection appear medically legitimate.
Patients are almost never informed of the true substance being injected, and few are warned of the severe health risks.
When we performed surgical removal, we found no collagen, but rather extensive deposits of silicone oil, necrotic tissue, and blocked lymphatic drainage channels. These complications can lead to chronic swelling, infections, and autoimmune reactions—some of which may take years to surface.
Patients Have No Idea They’re Full of Silicone Oil
One of the most troubling patterns we see is that patients have no idea they’ve been injected with silicone oil. Many are led to believe they’ve received a proprietary collagen stimulator or some kind of “natural” enhancement.
In reality, their lower extremities are often saturated with unregulated silicone compounds.
In a recent case, a patient experiencing severe complications was treated at a hospital emergency room. When the attending physician reached out to the original provider to ask what had been injected, the response was:
This statement is deeply misleading. Dimethicone is simply a pharmacological terms for silicone oil, and labeling it as “medical grade” or “pharmaceutical grade” does not make it safe.
These terms are not recognized by the FDA and are commonly used to obscure the reality: this is liquid silicone, and once injected, it never dissolves—it migrates, scars, and inflames tissue over time.
“Permanent, All Natural” Penile Enlargements — A Dangerous Marketing Spin
Clinics promoting these injections often describe them as “all natural,” “non-surgical,” and “collagen activating,” leading patients to believe they’re receiving a safe, biologically compatible substance that stimulates permanent growth.
In reality, these claims mask the use of silicone oil mixtures, often labeled with terms like “pharmaceutical grade silicone” or “dimethicone with CMC.” These names are used to make the product sound regulated and medically approved—but they are not.
The typical treatment involves injecting around 75 mL of silicone per session, which produces a noticeable increase in penile girth. To patients, it seems affordable, non-invasive, and effective. But for the provider, it’s also highly profitable—a driving factor behind its continued use, despite the known medical risks.
Some Providers Operate Without Malpractice Insurance
Another disturbing trend among clinics offering “collagen-inducing” or “permanent filler” injections is the absence of malpractice insurance. Patients often learn—too late—that the provider responsible for their complications isn’t insured.
In cases where a licensed medical professional does carry malpractice coverage, recurring claims typically lead to skyrocketing premiums or cancellation, creating a natural deterrent against reckless procedures.
But when providers lack insurance altogether, they can continue performing dangerous treatments—like silicone oil injections—without financial accountability.
This makes pursuing legal action extremely difficult. Patients are rarely able to find attorneys willing to take these cases on contingency, and filing a private lawsuit often requires an upfront investment of $10,000 or more just to initiate proceedings.
The result? Patients bear not only the physical and emotional cost, but also the full legal burden—with little chance of recourse against the provider who harmed them.
Physician-Owned Compounding Pharmacies
One reason these dangerous silicone injections continue under the radar is that some providers operate their own compounding pharmacies—allowing them to create the injectable mixture themselves, without oversight, and then market it using misleading terms like “pharmaceutical grade silicone.”
While compounding pharmacies are legally allowed to create custom formulations for individual patients, they are not permitted to duplicate commercially available drugs or use banned substances.
Compounded drugs are not FDA-approved, and the FDA does not review them for safety, efficacy, or quality prior to patient use. Oversight falls primarily to the state in which the pharmacy operates.
Federal regulation under Section 503A of the FD&C Act requires that:
- Each compound must be made only after receiving a valid, patient-specific prescription
- The prescription must follow an in-person evaluation by a licensed provider
However, based on reports and outcomes from affected patients, this legal protocol appears to be routinely ignored in these enhancement clinics. The result is unapproved silicone-based mixtures being injected into men’s bodies under the guise of custom medicine—without disclosure, regulation, or consequence.
Dangers of Injected Silicone
According to patients, an average of 75 ml per treatment into the groin area of their patients, and the average patient receives 1.75 treatments, equaling about 131 mL’s of injected silicone per patient.
The Dangers of Injecting Large Amounts of Silicone Into the Human Body
Injecting large volumes of silicone—regardless of how it’s labeled—poses serious, well-documented health risks. Whether marketed as medical-grade dimethicone, collagen filler, or pharmaceutical grade silicone, the material is the same: non-biodegradable, migratory silicone oil.
Reported complications include:
- Infections
- Hypersensitivity reactions
- Vascular embolization
- Granulomatous inflammation
- Nodule formation
- Skin distortion or discoloration
- Filler migration through lymphatic and vascular systems
- Autoimmune and systemic inflammatory disorders
One of the most concerning long-term effects is siliconosis—a musculoskeletal pain syndrome associated with chronic fatigue, joint pain (arthralgias), and muscle pain (myalgias).
Once silicone is injected, it cannot be broken down by the human body. It may migrate unpredictably to distant organs or lymph nodes, making complete surgical removal impossible and triggering complications years after the initial procedure.
The FDA has issued multiple public warnings against this practice. As stated on their website:
The FDA Warns Against Injectable Silicone and Dermal Fillers for Large-Scale Body Contouring and Enhancement
Are you considering a procedure to shape or increase the size of certain parts of your body? Beware of using injectable silicone for body contouring or any other unapproved products to achieve your goals. Injectable silicone is not approved by the U.S. Food and Drug Administration for any aesthetic procedure including facial and body contouring or enhancement. Silicone injections can lead to long-term pain, infections, and serious injuries, such as scarring and permanent disfigurement, embolism (blockage of a blood vessel), stroke, and death.
Silicone is not an injectable dermal filler. FDA-approved fillers are temporary and biodegradable. Silicone is neither.
Even when labeled with terms like “pharmaceutical grade,” silicone remains unapproved, unsafe, and irreversible once injected.
The Unique Dangers of Silicone Injections into the Groin Area
Injecting silicone into the penis introduces a set of complications that are particularly severe due to the anatomy of the groin and pelvic lymphatic system.
The most critical medical risks include uncontrolled migration of the silicone through lymphatic drainage channels and the onset of scrotal or penile lymphedema—a condition we explore in more detail in the following section.
But the consequences are not just physical.
Many men experience deep psychological trauma after discovering the material in their penis is not collagen or any natural filler—but silicone oil, misrepresented under terms like “collagen-inducing filler” or “pharmaceutical grade silicone.”
The patient shown here came to our clinic after receiving one such injection. What he believed was a safe, non-surgical enhancement turned out to be an unregulated silicone compound that caused visible deformities, painful granulomas, and emotional devastation.
The Specific Dangers of Silicone Injections in the Groin Area
While infections, granulomas, and nodule formation are common complications, the most dangerous long-term effect of silicone injections in the groin is their disruption of the body’s lymphatic drainage system.
Once injected, silicone oil—often mislabeled as pharmaceutical grade—can migrate through lymphatic channels and clog or damage pelvic lymph nodes, leading to chronic swelling, pain, and impaired immune response.
The groin and scrotal sac serve as major drainage hubs for lymphatic flow in the lower body. When these systems are blocked by silicone droplets, the result is often scrotal or penile lymphedema, which can progress to infection, tissue damage, and debilitating physical and psychological outcomes.
What is the lymphatic system?
The lymphatic system is a vital part of your body’s immune defense. It helps protect against infection, regulate fluid balance, and remove toxins and waste from tissues.
It’s made up of a network of vessels that carry a fluid called lymph, which moves through lymph nodes—small, filter-like structures that trap bacteria, viruses, and other harmful substances.
In the groin and pelvic area, this system plays a key role in clearing fluids from the penis, scrotum, and surrounding tissues. When silicone oil migrates into these drainage pathways—especially in high volumes—it can obstruct the lymphatic system, leading to painful swelling, inflammation, and a breakdown in the body’s ability to regulate immune response.
What causes lymphedema?
Lymphedema is a form of chronic swelling that occurs when the body’s lymphatic system is blocked or damaged. This obstruction causes lymph fluid to accumulate in soft tissues, leading to visible swelling, discomfort, and an increased risk of infection.
While lymphedema most often affects the arms and legs, it can also appear in more sensitive areas—including the genital region, torso, head, or neck.
The severity can range from mild fluid retention to severe hardening and thickening of the skin, often accompanied by pain, restricted movement, or recurrent infections. When silicone injections are involved—particularly in the groin—the risk of this complication increases significantly.
Is lymphedema potentially fatal?
While lymphedema most commonly presents as swelling in the limbs or lower body, untreated cases can progress into serious and potentially fatal infections. In its early stages, lymphedema may seem manageable—but without intervention, it can lead to recurrent bacterial infections, chronic pain, and long-term disability.
Regular lymphatic drainage is essential to immune function and the removal of toxins and waste from the body. When this process is disrupted—especially by foreign substances like injected silicone—the consequences can be severe.
In February 2024, our team performed a duplex Doppler ultrasound on a patient who had received what was described as a “collagen activation injection” for Peyronie’s Disease.
The patient believed the changes in his anatomy were due to his body’s natural collagen production.
However, ultrasound imaging revealed the presence of silicone deposits, not collagen.
Even more concerning, the opaque areas indicating silicone had migrated across the entire lower pelvic region, nearing the lymph nodes—raising the risk of full lymphatic obstruction and systemic complications.
We have recommended further diagnostic testing, as the full extent of his internal damage is still being evaluated.
Case Study: Scrotal Injections Leading to Severe Lymphedema
In many cases of penile girth enhancement using hyaluronic acid fillers, the body compensates for lymphatic disruption in the penis by rerouting drainage through the scrotal lymphatic system, which is larger and more resilient.
However, this compensation fails when injections are also performed in the scrotum.
One patient presented to our clinic six years after receiving a so-called “collagen-inducing” injection into both his penile shaft and scrotum. The treating provider told him that the material used would stimulate natural collagen production and result in permanent enlargement—a common but misleading claim associated with liquid silicone oil marketed as “pharmaceutical grade” or “collagen-activation filler.”
The patient arrived with acute scrotal pain. Physical examination revealed a scrotum that was hardened, swollen, and highly sensitive to the touch—classic signs of scrotal lymphedema.
A biopsy confirmed the presence of hundreds of silicone microdroplets and the formation of silicone granulomas. All infectious disease cultures—including bacterial, fungal, and atypical mycobacterium—were negative, confirming that the inflammation was a foreign body reaction to silicone, not an infection.
This case highlights the long-term risks of injecting unregulated substances into sensitive areas of the male anatomy—especially when patients are misled about the safety and permanence of these materials.
Silicone injections do not trigger collagen production.
The patient in this case was never informed that the substance injected into his scrotum contained liquid silicone—let alone that it was marketed as “collagen-activating” or “pharmaceutical grade.” Even with informed consent, however, the science is clear: silicone does not induce long-lasting collagen growth.
While certain FDA-approved dermal fillers like cross-linked hyaluronic acid have shown limited potential to stimulate collagen production, silicone oil behaves very differently in human tissue.
When injected, silicone forms microdroplets ranging from 20 to 100 µm, which can migrate either by gravity or through tissue planes. There are two types of migration:
- Large-volume migration, where silicone disperses between tissue layers.
- Small-volume migration, where microdroplets are partially engulfed by macrophages and travel through the lymphatic system.
In the patient we examined, his scrotal lymphatic drainage became obstructed, likely due to the accumulation of larger silicone droplets that were too large to be phagocytosed. These larger particles remained embedded, triggering an immune response on their surfaces.
Over time, the body responds by forming fibrous capsules and granulomas, not collagen. The immune system recognizes the silicone as a foreign substance, leading to chronic inflammation, tissue damage, and potential systemic complications—not rejuvenation or enhancement.
Understanding the Body’s Lymphatic Drainage System
The lymphatic system is a vital part of the immune system and plays a central role in regulating the body’s fluid balance. It consists of a network of vessels and lymph nodes that circulate lymph fluid—a clear liquid that contains white blood cells, waste products, and other immune factors.
Lymph nodes are small, bean-shaped structures that act as filters, trapping harmful substances such as bacteria, viruses, and foreign particles—including silicone microdroplets if they migrate after injection. These nodes are densely located in areas such as the armpits, neck, and pelvis.
Of particular concern in penile enhancement procedures is the pelvic lymphatic system, which includes nodes situated near the hip bones and groin.
These nodes support lymphatic drainage from the penis and scrotum. When this drainage is disrupted—such as by silicone injection migration—it can lead to swelling, inflammation, and serious lymphatic complications like scrotal lymphedema.
This system is also a pathway through which cancer cells—such as those from the prostate or bladder—can spread to other parts of the body. Any interference with lymphatic function, especially in the pelvic or genital region, can therefore have broader health implications.
What is lymphedema?
Definition: Lymphedema is a medical condition characterized by the buildup of lymphatic fluid in soft tissues, typically resulting from infection, trauma, or obstruction of the body’s normal lymphatic drainage channels. This fluid accumulation causes chronic swelling, often accompanied by discomfort, skin thickening, and an increased risk of infection.
While lymphedema is most commonly associated with cancer treatments like surgery or radiation, it can also result from heart failure, liver disease, or—critically—blockage of the lymphatic system due to silicone oil injections.
In one of our clinical cases, a patient developed scrotal lymphedema following injections of large volumes of silicone oil into the scrotal sac. These were not the rare, off-label microdroplet silicone injections sometimes used in dermatology (typically 0.01 to 0.03 mL).
Instead, this patient received high-volume injections under the false claim of a “collagen-inducing” filler—without ever being informed that liquid silicone was the substance being used.
The scrotal dermis is one of the most delicate and fragile tissues in the body—comparable in thickness to the skin of the eyelid. When silicone is injected into this tissue, it disperses in the dermis and prompts a foreign body immune response, drawing macrophages and giant cells to form granulomas.
These granulomas may not appear immediately. Their development often follows a cyclical pattern of inflammation, dormancy, and reactivation—sometimes occurring years after the initial injection.
Larger quantities of silicone significantly worsen this effect, leading to more severe tissue damage, swelling, and eventual dysfunction of the lymphatic system in the groin and pelvis.
What happens when a patient develops scrotal lymphedema?
Scrotal lymphedema is a distressing condition characterized by the buildup of lymphatic fluid in the soft tissues of the genital region, leading to visible swelling, discomfort, and, in some cases, loss of function.
While this condition is most commonly associated with cancer treatments, radiation, or surgery, it can also result from damage or obstruction to the lymphatic system caused by injected silicone oil.
When silicone migrates into the lymphatic channels—especially in the scrotum—it can severely impair fluid drainage, triggering chronic swelling and immune dysfunction.
In cases involving silicone girth injections, patients are often unaware that the substance injected was silicone, let alone that it could interfere with their body’s ability to eliminate toxins and maintain immune balance.
Once the lymphatic flow is compromised, fluid backs up in the genital region, producing a heavy, spongy, and painful scrotum. This type of lymphedema often worsens over time and may become irreversible without surgical intervention.
Giant Scrotal Lymphedema from Silicone Injections
In rare but severe cases, men develop giant scrotal lymphedema, a debilitating condition in which the scrotum becomes grossly enlarged due to fluid accumulation caused by obstruction of the lymphatic drainage system.
This condition is particularly devastating when triggered by injected silicone oil used for penile or scrotal enhancement.
The scrotal tissue, overwhelmed by trapped lymphatic fluid, often becomes thickened, sponge-like, and chronically infected. In the case observed at our clinic, the patient’s scrotum had become leathery and distended, with complete blockage of the lymphatic outflow, resulting in toxic fluid backup into the pelvic lymph nodes.
This impaired drainage not only causes pain and disfigurement but also increases the risk of developing prostate or testicular cancer. Patients may become housebound due to the physical burden and emotional distress caused by the swelling, pain, and loss of normal genital function.
Although scrotal edema can be caused by conditions like heart failure, liver disease, trauma, or complications from peritoneal dialysis, in these emerging cases it is clearly linked to non-surgical silicone girth injections marketed as “natural collagen fillers.”
Surgical intervention is often required to restore form and function and to relieve the buildup of toxins and inflammatory byproducts caused by the blocked lymphatic system.
Silicone Injections in the Scrotum Can Trigger Life-Threatening Complications
Injecting liquid injectable silicone (LIS) into the scrotum for cosmetic enhancement poses significant and well-documented medical risks. Despite ongoing controversy and FDA warnings, some providers continue to use silicone off-label in ways that result in serious harm to patients.
Silicone is a hydrophobic compound that disperses in the dermis as droplets. These droplets trigger a foreign body immune response, attracting macrophages and forming granulomas—dense clusters of inflammatory cells.
These reactions may appear months or even years after injection and often follow a cycle of flare-ups and temporary relief.
This risk is magnified in the scrotal dermis, which is extremely thin and fragile. The scrotum plays a vital role in lymphatic drainage from the pelvic region. When this system becomes clogged with silicone, it results in scrotal lymphedema—a painful and dangerous condition marked by swelling, fluid retention, and skin thickening.
In the case we examined, the patient’s lymphedema stemmed from cosmetic silicone injections into the lower scrotum. His lymphatic drainage had become fully obstructed, leading to massive fluid buildup and elevated risk of pelvic malignancies such as testicular or prostate cancer.
The patient reported that many others had undergone the same procedure, suggesting that scrotal lymphedema caused by silicone injections may be more widespread than currently recognized.
Without early evaluation by a qualified urologist, patients may face irreversible complications or life-threatening outcomes.
Treatment Options for Scrotal Lymphedema Caused by Silicone Injections
Treating scrotal lymphedema caused by injected silicone is complex due to the nature of the material.
Silicone oil disperses into microdroplets that infiltrate surrounding vascular and lymphatic tissue, making complete removal nearly impossible and increasing the risk of ongoing health complications.
The most effective course of action is surgical intervention. This approach not only aims to remove compromised tissue and silicone deposits, but also helps restore proper urinary and, when possible, sexual function.
Once the affected scrotal tissue has been excised, reconstruction with skin grafts is often possible. In many cases, there is enough healthy tissue around the scrotum to reconstruct an appearance that is both functional and cosmetically acceptable.
In advanced lymphedema cases, the penis may become engulfed in fluid-filled scrotal tissue, with the foreskin inverting and trapping the shaft. If any penile tissue remains unaffected, it may be preserved.
However, if the epidermis of the penis has been compromised by inflammation or scarring, it may need to be removed and replaced with a skin graft, which can prevent recurrence of a buried penis and restore a normal anatomical profile.
Silicone-induced scrotal lymphedema presents greater risks than typical cases due to:
- widespread granuloma growth
- irreversible damage to the thin, sensitive scrotal dermis
- the inability to extract all silicone droplets surgically
Without prompt and specialized urologic care, patients face a potentially life-threatening condition, chronic infection, disfigurement, and long-term impairment of sexual and urinary function.
How Rejuvall Repairs Damage from Pharmaceutical Grade Silicone Injections
At Rejuvall Health Centers, we routinely treat men who have suffered complications from so-called “pharmaceutical grade silicone” injections used for penile or scrotal enlargement.
Our surgical team specializes in the removal and repair of silicone girth injections, which often involves complex reconstructive techniques. Because silicone oil cannot be metabolized by the body, it tends to migrate, form granulomas, and disrupt the body’s lymphatic and vascular systems.
Using high-resolution imaging like duplex Doppler ultrasound, we can map the extent of silicone infiltration and develop a treatment plan tailored to the patient’s anatomy and symptoms.
Depending on severity, treatment may include excision of damaged tissue, removal of silicone pockets, reconstruction with skin grafts, and restoration of lymphatic drainage in cases involving lymphedema.
While it is rarely possible to remove 100% of the injected silicone, our focus is on restoring natural appearance, minimizing pain, and improving sexual function.
For more information on how we address complications from these illegal or misleading procedures, please see our page on Rejuvall’s silicone girth enhancement repair techniques.
