Not All Silicone Is Medical-Grade. And On a Compromised Scalp, the Wrong Grade Is Not a Minor Issue.
- Hairline Illusions
- 5 days ago
- 7 min read
The word "cranial prosthesis" is not a material specification.
It is a marketing decision. And right now, it is being made without conscience.
A growing number of products are being sold under the clinical title of cranial prosthesis while being constructed with industrial-grade silicone. Not medical-grade. Not biocompatibility-tested. Industrial silicone, the same class of material used in machinery, sealants, and manufacturing applications, placed against the scalps of cancer patients, burn survivors, and children with alopecia.
The cost difference between industrial and medical-grade silicone is significant. That savings goes into the manufacturer's margin. The risk goes onto the client's scalp.
This is not a fringe issue. It is widespread. And the industry is not talking about it.
What Makes the Two Grades Different.
Medical-grade silicone is engineered for prolonged skin contact. It undergoes biocompatibility testing under ISO 10993, the international standard for materials used in medical devices. It is formulated to minimize reactivity with human tissue, control moisture vapor transmission, limit heat retention, and leave no harmful residual compounds after the curing process.
Industrial silicone carries none of those requirements. It is cured using different chemical systems, frequently organotin compounds such as dibutyltin and tributyltin, which serve as catalysts during the vulcanization process. These compounds are not inert. They are not designed for skin contact. And they do not fully leave the material after curing.
Organotin compounds used in silicone production have been identified as potential immunotoxins and endocrine disruptors. The CDC's Agency for Toxic Substances and Disease Registry notes that some organotin compounds have shown immune system effects in animal studies, with the thymus and lymphocyte function being particularly affected. These are the compounds left behind in industrial silicone when it is not properly purified, and they are the compounds now sitting against the scalps of medically vulnerable clients across this country.
When It Is Not Even Silicone.
The problem does not stop at grade. It extends into outright material misrepresentation, and this is where the industry's accountability gap becomes something closer to fraud.
A significant number of products currently marketed and sold as silicone cranial prosthetics are not silicone at all. They are constructed from polyurethane, polymer composites, or PU-blend materials, labeled and sold under the silicone name because silicone carries the clinical association those manufacturers want, without the cost or standards that genuine silicone requires.
Polyurethane is a petrochemical-based synthetic that was never engineered for prolonged skin contact in medically vulnerable populations. It is less breathable than silicone, degrades faster under heat and chemical exposure, and can off-gas isocyanate-related breakdown compounds as it ages. On a healthy scalp, a client may notice premature material deterioration, odor, or skin discoloration. On a post-chemotherapy or post-radiation scalp, the risks are compounded by everything already described in this article.
PU materials also respond differently to the topical medications, scalp treatments, and environmental conditions that medical clients live with daily. A material that breaks down under chemical exposure does not just fail structurally. It fails biologically, releasing its degradation products directly onto tissue that has almost no capacity to manage additional chemical stress.
Some manufacturers use the term "polymer" as a deliberate obscuring strategy, a broad enough category to avoid the specific accountability of naming the actual material while still sounding technical and intentional. When a manufacturer cannot or will not name the precise material composition of their product, that is not an oversight. It is information they have chosen not to give you.
What Degrades Into the Scalp.
This is where the conversation about PU and polymer-based prosthetics becomes more serious than most people in this industry are prepared to discuss.
Plastic materials do not simply sit passively against the skin. As polyurethane and polymer composites age, are exposed to heat, sweat, and daily wear, they degrade. That degradation releases chemical additives, including plasticizers and processing compounds, directly onto the skin surface. Research published in Environment International and conducted using 3D human skin models demonstrated that toxic chemical additives from plastics can leach into human sweat and subsequently be absorbed through the skin barrier into the bloodstream. The University of Birmingham researchers who led that study noted that these chemicals are persistent, meaning with continuous or regular exposure there is gradual accumulation to the point where they begin to cause harm.
The skin barrier on a healthy scalp already limits what can penetrate. On a post-chemotherapy or post-radiation scalp, that barrier is not intact. It is compromised, thinned, and in many cases actively breaking down. Research confirms that damaged skin dramatically increases the absorption of chemical compounds that an intact barrier would otherwise restrict.
A client wearing a PU or polymer prosthetic eight or more hours a day, against a scalp whose barrier has been weakened by treatment, is not simply wearing a cosmetic product. They are in prolonged daily contact with a degrading petrochemical material against tissue that has lost its primary defense mechanism.
This is not theoretical risk. It is a documented biological pathway that the industry has not been asked to account for, because the industry has not been required to ask the question.
What Happens to a Compromised Scalp. Stage by Stage.
The damage does not always announce itself. That is what makes it so dangerous. Many of the worst outcomes in this space begin as something a client describes as "a little irritation."
Stage One: Subclinical Irritation.
The scalp shows no visible reaction. The client feels mild warmth, intermittent itching, or a vague discomfort they attribute to the prosthetic being new. Chemotherapy and radiation therapy disrupt rapidly dividing cells, including those responsible for maintaining the skin barrier, leaving the integument with compromised integrity, reduced resilience to friction, and heightened sensitivity to chemical and mechanical stimuli. At this stage, industrial silicone or PU residuals are making contact with a barrier that is already impaired. The client does not know. The professional does not see it.
Stage Two: Inflammatory Response.
Industrial and lower-grade silicone products can contain residual catalysts, pigments with metal ions, plasticizers, and organotin curing agents. These compounds trigger inflammatory responses in sensitive skin, with contact dermatitis presenting as redness, small raised lesions, and itching that matches the exact shape of the material in contact with the skin. On a healthy scalp, this might resolve with removal of the product. On a post-chemotherapy or post-radiation scalp, the inflammatory response is compounded by an immune system that is already dysregulated. The skin cannot mount a normal response. It cannot repair itself on a normal timeline.
Research has shown that when silicone compounds come into contact with human monocytes, they can stimulate elevated levels of pro-inflammatory cytokines including IL-1β, IL-6, and TNF-α, indicating an active immune response at the cellular level. For a client on immunosuppressive agents or active chemotherapy, this cytokine activity is not benign. It adds biological stress to a system already under considerable load.
Stage Three: Barrier Breakdown and Microbial Vulnerability.
Industrial silicone and PU materials trap heat and moisture differently than medical-grade silicone. On a scalp that is already dry, thin, and compromised by treatment, this creates an occlusive microenvironment. Warmth, trapped moisture, and disrupted skin flora are the conditions under which bacterial and fungal organisms thrive.
The National Cancer Institute notes that radiation therapy can cause the skin to peel, become wet, and develop infected sores, particularly in areas where friction and moisture accumulate. Irritated skin is directly vulnerable to infection, and preventing infection is a primary concern in oncology skin care. When a poorly constructed prosthetic becomes the source of that irritation, the professional wearing the clinical title has become the risk factor.
For a neutropenic patient, someone whose white blood cell count is already depleted by chemotherapy, a scalp infection is not a dermatological inconvenience. It is a medical emergency. Sepsis risk in neutropenic patients is real, serious, and fast-moving. The professional who placed that prosthetic may never make the connection between the fitting and the hospitalization that followed.
Stage Four: Chronic Inflammatory Dermatitis and Tissue Damage.
Research on radiation-induced dermatitis confirms that fibrosis, atrophic tissue changes, and compromised vasculature are established late complications of radiation to the scalp. These tissues have significantly reduced capacity for repair. When industrial silicone or degrading PU continues to mechanically irritate and chemically stress this tissue over weeks or months of daily wear, the skin does not simply bounce back. Chronic inflammatory dermatitis can develop. Pigmentation changes occur. In documented cases, silicone-related contact dermatitis has been followed by depigmentation of the affected skin. Granuloma formation, while rare, has also been reported in cases of prolonged silicone exposure.
For clients with autoimmune-related hair loss, the picture is even more complicated. The scalp may appear intact while inflammation operates below the surface. Unpredictable tolerance shifts mean a client who wore the prosthetic without incident for months may suddenly develop a severe reaction as their disease activity changes. Industrial silicone and PU materials provide no safety margin for that variability. Medical-grade silicone, properly selected and clinically assessed, at least gives us a starting point of known biocompatibility.
The Label Is Not the Standard.
Manufacturers know that "cranial prosthesis" carries clinical weight. They know that oncologists, social workers, and insurance providers respond to that language. They use it deliberately, without the material standards, biocompatibility testing, or clinical training to support it.
The professional in the fitting room is the last line of accountability. Not the manufacturer. Not the label. The professional.
Before fitting any silicone-based prosthetic on a medically vulnerable client, these questions must have answers:
What grade of silicone is this constructed from? What curing system was used, and what residual compounds remain? Has this material been tested for biocompatibility under ISO 10993? Can the manufacturer provide documentation? Is this actually silicone, or is it polyurethane or a polymer composite being sold under a different name? Has this product been evaluated for use on immunocompromised, post-radiation, or autoimmune scalps specifically?
If those questions cannot be answered, the product is not appropriate for a medical client, regardless of what it is called.
We manufacture our cranial prosthetics in America using medical-grade silicone specifically because these questions have answers. The cost is higher. The accountability is real. And the people on the other side of that fitting table have already been through enough.
The clinical title of cranial prosthesis must mean something.
We intend to make sure it does.
If you want to go deeper on material science, scalp physiology, and foundation selection for medically vulnerable clients, this is exactly what we cover in The Science of Wig Foundations: A Clinical Guide to Scalp Health. This volume was written for professionals who understand that what sits against a compromised scalp is a clinical decision, not a product preference.
Pre-order your copy and learn more at hairlineillusions.com/books.
©2026 Hairline Illusions™ Arts, Science and Technology Institute. All rights reserved.
References
Comments