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Complications of Devices, Implants, and Grafts

Related Terms

Allograft Rejection
Device Rejection
Leaking or Deteriorating Breast Implant

Specialists

Cardiovascular Internist
General Surgeon
Gynecologist
Internal Medicine Physician
Neurosurgeon
Ophthalmologist
Oral / Maxillofacial Surgeon
Orthopedic (Orthopaedic) Surgeon
Plastic Surgeon
Radiologist
Thoracic Surgeon
Vascular Surgeon

Comorbid Conditions

Circulatory disorders
Compromised immune system
Diabetes
Obesity

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Duration of disability depends on the underlying cause of the disorder being treated with device, graft or implant, the type of surgical procedure and the specific complication(s) that develop as well as the type of treatment for the complication and response to treatment.

Medical Codes

	ICD-9-CM:
	996.01 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Mechanical Complication due to Cardiac Pacemaker (Electrode)
	996.02 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Mechanical Complication due to Heart Valve Prosthesis
	996.03 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Mechanical Complication due to Coronary Bypass Graft
	996.1 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Mechanical Complication of Other Vascular Device, Implant, and Graft; Mechanical Complications involving: Aortic (bifurcation) Graft (Replacement), Arteriovenous Dialysis Catheter, Fistula or Shunt Surgically Created
	996.2 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Mechanical Complication of Nervous System Device, Implant, and Graft; Involving Dorsal Column Stimulator; Electrodes Implanted in Brain; Peripheral Nerve Graft; Ventricular (communicating) Shunt
	996.4 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Mechanical Complication of Internal Orthopedic Device, Implant, and Graft
	996.5 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Mechanical Complication of Other Specified Prosthetic Device, Implant, and Graft
	996.51 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Mechanical Complication due to Corneal Graft
	996.54 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Mechanical Complication due to Breast Prosthesis
	996.59 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Mechanical Complication due to Other Implant and Internal Device, Not Elsewhere Classified
	996.6 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Infection and Inflammatory Reaction due to Internal Prosthetic Device, Implant, and Graft
	996.61 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Infection and Inflammatory Reaction due to Cardiac Device, Implant, and Graft
	996.62 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Infection and Inflammatory Reaction due to Other Vascular Device, Implant, and Graft
	996.66 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Infection and Inflammatory Reaction Due to Internal Joint Prosthesis
	996.67 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Infection and Inflammatory Reaction Due to Other Internal Orthopedic Device, Implant, and Graft
	996.69 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Infection and Inflammatory Reaction Due to Other Internal Prosthetic Device, Implant, and Graft
	996.7 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Other Complications of Internal Prosthetic Device, Implant, and Graft
	996.70 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Other Complications Due to Unspecified Device, Implant, and Graft
	996.71 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Other Complications Due to Heart Valve Prosthesis
	996.72 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Other Complications Due to Other Cardiac Device, Implant, and Graft
	996.73 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Other Complications Due to Renal Dialysis Device, Implant, and Graft
	996.74 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Other Complications Due to Other Vascular Device, Implant, and Graft
	996.75 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Other Complications Due to Nervous System Device, Implant, and Graft
	996.76 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Other Complications Due to Genitourinary Device, Implant, and Graft
	996.77 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Other Complications Due to Internal Joint Prosthesis
	996.78 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Other Complications Due to Other Internal Orthopedic Device, Implant, and Graft
	996.79 -	Complications Peculiar to Certain Specified Procedures in the Use of Artificial Substitutes, Other Complications Due to Other Internal Prosthetic Device, Implant, and Graft

Definition

Devices, implants, and grafts all refer to surgical placement of a man-made mechanical, synthetic implantable material or biological implantable material into the body to correct a clinical condition. Advances in technology have dramatically increased the number of surgeries performed each year for grafts, implants, and devices. Complications refer to development of any unexpected or unwanted postoperative conditions related to the device, graft, or implant.

The most common type of grafts are skin grafts and bone grafts. The graft can be permanent or temporary. In the case of temporary grafts, the grafted material gradually is resorbed and replaced with new growth.

Material to form the graft can come from a variety of natural and synthetic sources. When tissue is removed from one area of the body and grafted into another area, it is called an autograft. When material is removed from another individual of the same species (either living or a cadaver) and used in a second individual, the graft is an allograft. When material is removed from one species and grafted into another species (e.g., grafts of pig skin into humans), the graft is a xenograft.

In addition, graft material can be completely synthetic. Common synthetic grafts are either ceramic-based (calcium phosphate or calcium sulfate) or polymer-based materials. Often grafts are a combination of these different materials. Each type of graft has benefits and drawbacks, along with differences in the incidences of complications.

The majority of implants (e.g., breast and cochlear implants) and surgical devices (e.g., knee and hip prostheses) are synthetic. Implants and devices are commonly made of a combination of metal, ceramic, and polymer plastics. Complications vary with the type of implant or device, its location in the body, the experience of the surgeon, and the health and immunological response of the individual. Metal sensitivity in some individuals may produce a biologic response to implantation of metallic orthopedic devices due to metal ion exposure and release.

Most complications fall into four general categories: bleeding and surgical complications, post-operative infection, immune response and rejection, and device failure. Bleeding and surgical complications can affect the patency of the graft, implant, or device, and may cause damage to the tissues surrounding the surgical site. For example, the most common reason for failure of a skin graft is inadequate contact with the recipient tissue bed; bleeding may cause blood to pool under the graft (hematoma), decreasing contact between the graft and the recipient's tissue. Other complications can arise from technical limitations when the graft or implant must be done at a difficult or suboptimal location. In some cases the recipient site is not well vascularized, reducing the flow of needed blood and oxygen to tissue and resulting in failure of the graft or implant. As in all surgery, blood clots or thrombophlebitis may develop during or after surgery, increasing the risk of pulmonary embolism or stroke (cerebrovascular accident).

Infection is a potential complication of all surgical procedures. However, risk is even greater in individuals with burns, where large sections of the air-skin barrier have been breached. In individuals receiving allografts, there is a low but real possibility that the tissue transferred from another individual will cause infection or disease.

An immune response to the graft, implant, or device, and subsequent rejection is also a common complication. Autografts are least likely to be rejected, since the tissue being grafted is harvested from the individual receiving the graft and the cells in the graft are still recognized by the immune system as self-cells when the tissue is moved to another place in the body. Occasionally, autograft rejections occur for unknown reasons.

Allograft rejection is more common. Allograft tissue can come from either a living donor or a cadaver. The tissue is often processed in ways that help to decrease the likelihood of an immune response and rejection by the recipient. An immune response and rejection is even more likely when a xenograft (cross-species graft) is performed. Rejection also can occur because of sensitivity toward synthetic material used in the implant or device. About 13% of the population has sensitivity to metals such as nickel, cobalt, and chromium (Rabin), which may be used in implants and devices. However, the role of metal sensitivity in device rejection remains controversial. Several studies have found that less than 0.1% of device rejection appears to be caused by metal sensitivity (Rabin), making the clinical significance of this reaction unclear.

Finally, devices can fail because they are improperly implanted, break down, wear out, or migrate out of position. For example, the breakdown of silicone breast implants has received extensive coverage in the media. Device failure can occur almost immediately or years after the initial surgery. In addition, implants that are intended as temporary may fail if they are not resorbed by the body as expected.

Risk: Risk of complications depends on the type of procedure, the experience of the surgeon, the health of the individual and underlying conditions that necessitate the graft, implant, or device. Risk of complications can range from minimal for implantation of a drainage device, to much higher for procedures such as heart valve replacement. The postoperative risk for infection and rejection of devices, implants, and grafts is higher than other possible complications.

Incidence and Prevalence: The most common postoperative complication of indwelling devices and implants is infection; nearly half of the 2 million hospital-related infections (nosocomial infections) reported annually are associated with indwelling devices and implants (Daroiche).

Surgical procedures using grafts, implants, and devices are common. By one estimate, more than half a million bone grafts were performed in the US and 2.2 million worldwide in 2005, with the number expected to increase steadily (Laurencin). Skin grafts are commonly used in individuals with burns. Increasingly, grafts and implants are used in the practice of elective cosmetic surgery. Even corneas can be transplanted in a graft procedure.

In 2005, more than 4 million American women were living with breast implants; of those, 70% to 80% had implant surgery for cosmetic reasons. (Brody).

More than 120,000 total hip replacements are performed in the US each year, with about 800,000 being performed worldwide (Jacobson).

Source: Medical Disability Advisor

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