What is Metallosis?

The Problem

Many medical devices commonly used in health care today are made out of different types of metals. In orthopedics and podiatry, a variety of implantable devices including screws, plates, wires, etc. are routinely used by surgeons for a wide range of bone related surgical procedures where small bones in the body, such as in the hands, arms, feet and ankles, need to be set and secured in place (i.e. bone fixation) so they can properly heal. Examples include repairing bone fractures and surgeries where cutting and repositioning bones is necessary to correct deformities, misalignment, etc. such as bunion correction surgery. The problem is that these traditional metal devices are designed to remain inside the body indefinitely and over time can corrode and degrade releasing metallic debris that gets circulated throughout the body via the bloodstream. The metal material can accumulate at the original repair site as well as in adjacent or distant tissues and organs in other parts of the body which can lead to significant health problems for patients including metal toxicity/poisoning, inflammation, pain and even cause various diseases and disorders.

Examples of Metal Toxicity/Poisoning From Metal Implants

Metallosis from a single screw implant

Local reaction of stressed bone plate across joint

Absorption of titanium bone plate into bone

Some Relevant Data

• In studies comparing patients with no metal implants in their bodies to those with implants, although those patients with no implants can still have detectable levels of metal in their bodies from other sources, blood concentrations were shown to be significantly higher for all the patients with implants. Source: Titanium release in serum of patients with different bone fixation implants and its interaction with serum biomolecules at physiological levels. Analytical and Bioanalytical Chemistry, 2011; DOI:
• Titanium release in serum of patients with different bone fixation implants and its interaction with serum biomolecules at physiological levels
• Heavy metal: Titanium implant safety under scrutiny


• $1.4 billion settlement announced in artificial hip litigation; Plaintiffs in 39 states, including hundreds in Minnesota, claim defective artificial hips sold by Stryker caused illness. Hundreds of Minnesotans whose artificial hips leaked metal into their bloodstreams will get settlements of at least $300,000 following a $1.4 billion settlement announced Monday in a Minneapolis federal courtroom.
• $1.4 billion settlement announced in artificial hip litigation

The Solution

SafetyFix Medical Technologies has created, tested and received full regulatory approvals for the SafetyFix EasyOut Bone Fixation Screw System, the first and only implantable device designed for temporary bone fixation and quick and easy removal once sufficient bone healing has occurred. The exclusive patented design has a proven safety record allowing the surgeon to safely remove the screw in a simple procedure that can be performed in as little as 2 minutes so that no metal is left in the body that can cause health problems and complications in the future. By going metal-free with the SafetyFix Screw System, patients and their doctors can have the peace of mind that comes from knowing they will not have to worry about having potentially toxic metal substances permanently left in their bodies.