ISO 16054:2000 Implants for surgery minimum data sets for surgical implants

Courtesy: ISO 16054:2000 Implants for surgery minimum data sets for surgical implants

Commonly implanted metals

A variety of minimally bioreactive metals are routinely implanted. The most commonly implanted form of stainless steel is 316L. Cobalt-chromium and titanium-based implant alloys are also permanently implanted. All of these are made passive by a thin layer of oxide on their surface. A consideration, however, is that metal ions diffuse outward through the oxide and end up in the surrounding tissue. Bioreaction to metal implants includes the formation of a small envelope of fibrous tissue. The thickness of this layer is determined by the products being dissolved, and the extent to which the implant moves around within the enclosing tissue. Pure titanium may have only a minimal fibrous encapsulation. Stainless steel, on the other hand, may elicit encapsulation of as much as 2 mm.

List of implantable metal alloys

Stainless Steel

• ASTM F138/F139 316L
• ASTM F1314 22Cr-13Ni–5Mn

Titanium Alloy

• ASTM F67 Unalloyed (Commercially Pure) Titanium
• ASTM F136 Ti-6Al-4V-ELI
• ASTM F1295 Ti-6Al-7Nb
• ASTM F1472 Ti-6Al-4V

Cobalt Chrome Alloy

• ASTM F90 Co-20Cr-15W-10Ni
• ASTM F562 Co-35Ni-20Cr-10Mo
• ASTM F1537 Co-28Cr-6Mo

Tantalum

Porosity in Implants

Porous implants are characterized by the presence of voids in the metallic or ceramic matrix. Voids can be regular, such as in additively manufactured (AM) lattices, or stochastic, such as in gas-infiltrated production processes. The reduction in the modulus of the implant follows a complex nonlinear relationship dependent on the volume fraction of base material and morphology of the pores.

Experimental models exist to predict the range of modulus that stochastic porous material may take. Above 10% vol. fraction porosity, models begin to deviate significantly. Different models, such as the rule of mixtures for low porosity, two-material matrices have been developed to describe mechanical properties.

AM lattices have more predictable mechanical properties compared to stochastic porous materials and can be tuned such that they have favorable directional mechanical properties. Variables such as strut diameter, strut shape, and number of cross-beams can have a dramatic effect on loading characteristics of the lattice. AM has the ability to fine-tune the lattice spacing to within a much smaller range than stochastically porous structures, enabling the future cell-development of specific cultures in tissue engineering.

Porosity in implants serves two primary purposes

1) The elastic modulus of the implant is decreased, allowing the implant to better match the elastic modulus of the bone. The elastic modulus of cortical bone (~18 MPa) is significantly lower than typical solid titanium or steel implants (110MPa and 210 MPa, respectively), causing the implant take up a disproportionate amount of the load applied to the appendage, leading to an effect called stress shielding.

2) Porosity enables osteoblastic cells to grow into the pores of implants. Cells can span gaps of smaller than 75 microns and grow into pores larger than 200 microns. Bone ingrowth is a favorable effect, as it anchors the cells into the implant, increasing the strength of the bone-implant interface. More load is transferred from the implant to the bone, reducing stress shielding effects. The density of the bone around the implant is likely to be higher due to the increased load applied to the bone. Bone ingrowth reduces the likelihood of the implant loosening over time because stress shielding and corresponding bone resorption over extended timescales is avoided. Porosity of greater than 40% is favorable to facilitate sufficient anchoring of the osteoblastic cells.

Complications

Complications can arise from implant failure. Internal rupturing of a breast implant can lead to bacterial infection, for example.

Under ideal conditions, implants should initiate the desired host response. Ideally, the implant should not cause any undesired reaction from neighboring or distant tissues. However, the interaction between the implant and the tissue surrounding the implant can lead to complications. The process of implantation of medical devices is subjected to the same complications that other invasive medical procedures can have during or after surgery. Common complications include infection, inflammation, and pain. Other complications that can occur include risk of rejection from implant-induced coagulation and allergic foreign body response. Depending on the type of implant, the complications may vary.

When the site of an implant becomes infected during or after surgery, the surrounding tissue becomes infected by microorganisms. Three main categories of infection can occur after operation. Superficial immediate infections are caused by organisms that commonly grow near or on skin. The infection usually occurs at the surgical opening. Deep immediate infection, the second type, occurs immediately after surgery at the site of the implant. Skin-dwelling and airborne bacteria cause deep immediate infection. These bacteria enter the body by attaching to the implant’s surface prior to implantation. Though not common, deep immediate infections can also occur from dormant bacteria from previous infections of the tissue at the implantation site that have been activated from being disturbed during the surgery. The last type, late infection, occurs months to years after the implantation of the implant. Late infections are caused by dormant blood-borne bacteria attached to the implant prior to implantation. The blood-borne bacteria colonize on the implant and eventually get released from it. Depending on the type of material used to make the implant, it may be infused with antibiotics to lower the risk of infections during surgery. However, only certain types of materials can be infused with antibiotics, the use of antibiotic-infused implants runs the risk of rejection by the patient since the patient may develop a sensitivity to the antibiotic, and the antibiotic may not work on the bacteria.

Inflammation, a common occurrence after any surgical procedure, is the body’s response to tissue damage as a result of trauma, infection, intrusion of foreign materials, or local cell death, or as a part of an immune response. Inflammation starts with the rapid dilation of local capillaries to supply the local tissue with blood. The inflow of blood causes the tissue to become swollen and may cause cell death. The excess blood, or edema, can activate pain receptors at the tissue. The site of the inflammation becomes warm from local disturbances of fluid flow and the increased cellular activity to repair the tissue or remove debris from the site.

Implant-induced coagulation is similar to the coagulation process done within the body to prevent blood loss from damaged blood vessels. However, the coagulation process is triggered from proteins that become attached to the implant surface and lose their shapes. When this occurs, the protein changes conformation and different activation sites become exposed, which may trigger an immune system response where the body attempts to attack the implant to remove the foreign material. The trigger of the immune system response can be accompanied by inflammation. The immune system response may lead to chronic inflammation where the implant is rejected and has to be removed from the body. The immune system may encapsulate the implant as an attempt to remove the foreign material from the site of the tissue by encapsulating the implant in fibrinogen and platelets. The encapsulation of the implant can lead to further complications, since the thick layers of fibrous encapsulation may prevent the implant from performing the desired functions. Bacteria may attack the fibrous encapsulation and become embedded into the fibers. Since the layers of fibers are thick, antibiotics may not be able to reach the bacteria and the bacteria may grow and infect the surrounding tissue. In order to remove the bacteria, the implant would have to be removed. Lastly, the immune system may accept the presence of the implant and repair and remodel the surrounding tissue. Similar responses occur when the body initiates an allergic foreign body response. In the case of an allergic foreign body response, the implant would have to be removed.^[33]

Failures

The many examples of implant failure include rupture of silicone breast implants, hip replacement joints, and artificial heart valves, such as the Bjork–Shiley valve, all of which have caused FDA intervention. The consequences of implant failure depend on the nature of the implant and its position in the body. Thus, heart valve failure is likely to threaten the life of the individual, while breast implant or hip joint failure is less likely to be life-threatening.

Devices implanted directly in the grey matter of the brain produce the highest quality signals, but are prone to scar-tissue build-up, causing the signal to become weaker, or even non-existent, as the body reacts to a foreign object in the brain.

In 2018, Implant files, an investigation made by ICIJ revealed that medical devices that are unsafe and have not been adequately tested were implanted in patients’ bodies. In United Kingdom, Prof Derek Alderson, president of the Royal College of Surgeons, concludes: “All implantable devices should be registered and tracked to monitor efficacy and patient safety in the long-term.”