An implant is a medical device manufactured to replace a missing biological structure, support a damaged biological structure, or enhance an existing biological structure. Medical implants are man-made devices, in contrast to a transplant, which is a transplanted biomedical tissue. The surface of implants that contact the body might be made of a biomedical material such as titanium, silicone or apatite depending on what is the most functional. In some cases implants contain electronics e.g. artificial pacemaker and cochlear implants. Some implants are bioactive, such as subcutaneous drug delivery devices in the form of implantable pills or drug-eluting stents.
Applications
Examples of implants are pins, rods, screws, and plates used to anchor fractured bones while they heal. Other examples of implants are metal or polymer clips with intended use to prevent haemorrhage or occlude anatomic structures. There are self-locking loops, based on the construction of the traditional cable tie, designed for surgery. The device (LigaTie®) is intended for ligation purposes. By compressing tissue haemorrhage is prevented. The same material is used as in surgical suture (resorbable polymers), therefore the implant can be left in the body where after the material is resorbed (absorbed) by the tissue. A surgical mesh may be used for tissue support in hernia repair. The implant may be non-resorbable (permanent) or resorbable.
Contraceptive implants are used for birth control. A contraceptive implant is a small flexible tube measuring about 40mm in length which is inserted under the skin by a doctor (typically the upper arm). The implant is among the most effective birth control methods.
Classification
United States classification
Medical devices are classified by the US Food and Drug Administration (FDA) under three different classes depending on the risks the medical device may impose on the user. Class I devices are considered to pose the least amount of risk to the user and require the least amount of control. Class I devices include simple devices such as arm slings and hand-held surgical instruments. Class II devices are considered to need more regulation than Class I devices and are required to undergo specific requirements before FDA approval. Class II devices include X-ray systems and physiological monitors. Class III devices require the most regulatory controls since the device supports or sustains human life or may not be well tested. Class III devices include replacement heart valves and implanted cerebellar stimulators. Many implants typically fall under Class II and Class III devices.
Complications
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 along with several different complications. 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.
Failures
The many examples of implant failures include rupture of silicone breast implants, hip replacement joints, and artificial heart valves, such as the Bjorkâ€"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.
See also
- Biofunctionalisation
- List of orthopedic implants
- Mechanical heart valves
- Medical device
- Medical grade silicone
- Orthosis
- Prosthetics in fiction
References
- Basu, B., Katti, D., & Kumar, A. (2009). Advanced biomaterials: Fundamentals, processing, and applications. Hoboken, NJ: John Wiley & Sons, Inc.
- Black, J. (2006). Biological performance of materials: Fundamentals of biocompatibility. New York, NY: Taylor & Francis Group.
- Device classification. (2009, April 27). Retrieved from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm
- Dee, K., Puleo, D., & Bizios, R. (2002). An introduction to tissue-biomaterial interactions. Hoboken, NJ: John Wiley & Sons, Inc.
- D.F. Williams, Williams Dictionary of Biomaterials. Liverpool University Press, 1999 ISBN 978-0-85323-734-1; ISBN 0-85323-734-4
- Syring, G. (2003, May 6). Overview: Fda regulation of medical devices. Retrieved from http://www.qrasupport.com/FDA_MED_DEVICE.html
External links
- Contraceptive implant, guide to one of the latest developments in implant use.
- FDA information on implants, including the recommended questions for potential patients.
- American Association of Oral and Maxillofacial Surgeons guide to dental implants.
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