The increasing use of implantable medical devices has transformed healthcare outcomes across orthopaedics, dentistry, vascular and reconstructive procedures. From hip and knee replacements to vascular stents and hernia meshes, these devices restore function, improve quality of life and, in many cases extend the lives of patients.
Yet a silent threat undermines their effectiveness – biofilm on medical implants. These bacterial communities form on implant surfaces, creating chronic infections that are notoriously difficult to detect and treat. Their impact on both patient health and the healthcare system is profound.
In Australia, as elsewhere, infection and microbial biofilm are recognised as a major cause of implant failure. These infections can result in the need for corrective surgery, extended hospitalisation, and in severe cases, may lead to death. As bacteria readily form biofilms, they are nearly impossible to eradicate without removing the implant itself.
Understanding the role of biofilms
Biofilm on medical implants forms when bacteria adhere to and colonise synthetic surfaces of implants and secrete a self-protective layer. These biofilm structures are highly resistant to antibiotics and immune clearance. Medical implants, whether metallic or polymer-based, provide ideal conditions for biofilm development, making infection prevention especially challenging.
The consequences are serious and biofilms have been implicated in infections across a range of implantable devices, including:
Urinary and venous catheters
Orthopaedic implants
Dental implants
Breast implants
Hernia meshes
Vascular grafts
In orthopaedics, prosthetic joint infections (PJIs) affect approximately 1.7% of patients within two years of surgery.
In Australia alone, the estimated cost of managing PJIs exceeds AU$250 million annually.
The corresponding figure for PJI in the US is almost US$2 billion annually.
These infections often require implant removal, long-term antibiotics and reconstructive surgery. Once an infection has occurred the likelihood of another infection after the revision surgery can increased significantly. The mortality rate for PJI is around 24% five years after two-stage revision surgery.
Why synthetic materials are vulnerable
The surfaces of most synthetic materials are hydrophobic (i.e., able to repel water) and bacteria readily attach to such surfaces. Hence, synthetic materials used in medical devices, Wwhether titanium, silicone or other polymers, attract enough bacteria to activate a biological response that promotes biofilm formation. Even under sterile surgical conditions, there is always the risk of bacteria landing on an implant.
Standard protocols like antibiotic prophylaxis and aseptic handling are critical, but alone they cannot prevent biofilm-related infections. Innovation in implant surface technologies is essential to help tackle this challenge.
In a recent interview, Angela Hewlett MD, MS, Professor of Infectious Diseases and Director of the Orthopedic Infectious Diseases Service at the University of Nebraska Medical Center, was quoted as saying:
“Prosthetic joint infections are the most dreaded complication of total joint arthroplasty [and the mortality rate after revision surgery] is on par with many concerning malignancies and other significant medical conditions.”
The role of BIOINVISIBLE in preventing biofilm formation
TekCyte’s surface coating technology, BIOINVISIBLE, offers a breakthrough approach to tackling this issue at its source. This biocompatible implant coating is drug-free and specifically engineered to form a surface barrier that prevents the attachment that leads to bacteria biofilm on medical implants.
BIOINVISIBLE creates a hyperbranched polyglycerol coating that forms a stable, ultra-thin hydrophilic film. This polymer layer is the opposite of hydrophobic (repels water), attracting water to the surface, to which bacteria find it difficult to attach and colonise (grow).
By disrupting this early-stage event, BIOINVISIBLE effectively reduces the conditions that allow biofilms to form and take hold.
Preclinical laboratory studies, using BIOINVISIBLE-coated titanium and polyurethane, demonstrate significantly lower rates of attachment of bacteria. These outcomes highlight the coating’s, effectiveness, and potential to reduce implant-related infections.
Drug-free, long-term protection without compromise
Unlike anti-microbial coatings (that either kill or stop bacteria from growing), and rely on temporary drug or chemical release, BIOINVISIBLE aims to provide long-term performance without exposure to toxic compounds. These chemicals that impact healing and cannot be used for some implants. It addresses several limitations of existing coatings, such as:
- Delayed integration of orthopaedic implants into bone
- Delayed healing of surrounding soft tissue
- Risk of severe irritation from the antimicrobial chemicals
- Increased risk of generating antimicrobial resistant bacteria
As detailed in TekCyte’s article, How BIOINVISIBLE-Coated Devices Can Reduce the Risk of Biofilm, preventing the initial adhesion of bacteria is critical in developing biofilm-resistant implants. BIOINVISIBLE addresses this challenge using a drug and antimicrobial-free coating technology designed to deliver stable, long-term protection against microbial colonisation.
Scalable, safe and environmentally responsible
BIOINVISIBLE is suitable for a broad range of implantable devices.
The coating process is scalable to meet future commercial volumes, and compatible with the most common sterilisation protocols. It has passed multiple ISO safety and biocompatibility tests, shows no cytotoxicity, and remains stable on titanium for up to three years at room temperature.
TekCyte’s manufacturing systems align to ISO13485 standards and are designed to minimise chemical waste and energy use, making the BIOINVISIBLE coating process both effecient and environmentally sustainable.
Elevating implant infection prevention as a healthcare priority
As demand for implantable medical devices continues to rise, so too does awareness of the role that biofilm on medical implants plays in infection and device failure. At the same time, growing resistance to antibiotics is reducing the effectiveness of one of the most relied-upon defences against post-surgical infection. This convergence of factors highlights an urgent need to shift focus toward preventative strategies that reduce the risk of infection from the outset.
A coordinated national approach, spanning research, clinical protocols and advanced medical device manufacturing, is essential to improve patient outcomes and reduce the long-term burden on the healthcare system.
TekCyte offers a forward-looking response to this challenge. BIOINVISIBLE’s drug- and antimicrobial-free, biocompatible coating helps prevent biofilm formation at the source, reducing reliance on antibiotics and improving the performance and longevity of implantable devices. By combining safety, durability and scalability, BIOINVISIBLE supports a future where fewer implants fail, fewer patients require revision surgeries, and healthcare systems are less burdened by cost and the growing threat of antimicrobial resistance.
Sources
(2023). BIOINVISIBLE Brochure. Retrieved from tekcyte.com/bioinvisible
(2023). How BIOINVISIBLE-Coated Devices Can Reduce the Risk of Biofilm. Retrieved from tekcyte.com
Moore et al. (2022). Hyperbranched polyglycerol coated vascular stents – a non-pharmacological approach to reducing device-triggered thrombosis and restenosis. DOI: 10.21203/rs.3.rs-1544665/v1
Australian Orthopaedic Association National Joint Replacement Registry
National Institutes of Health: Biofilms and Device-Associated Infections
Quote from , Angela Hewlett MD, MS, Professor of Infectious Diseases and Director of the Orthopedic Infectious Diseases Service at the University of Nebraska Medical Center 2024
