Implant failure

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Implant failure refers to the failure of any medical implant to meet the claims of its manufacturer or the health care provider involved in its installation. Implant failure can have any number of causes. The rates of failure vary for different implants.

Contents

The monitoring of the safety of implants is conducted within the context of broader pharmacovigilance.

Common types of failure

Material degradation

Implant failure can occur due to the degradation of the material an implant is made of. With time, mechanical degradation, in the form of wear or fatigue, or electrochemical degradation, in the form of corrosion, can occur. Biotoxicity, particularly in metal implants, can arise due to ion release.

Bacterial infection

Implants, made of synthetic materials, are naturally coated by a biofilm by the body, which may function as a favorable medium for bacteria growth. Implant failure due to bacterial infection of the implant can occur at any point of implant lifetime. Bacteria may already reside on the implant or be introduced during the implantation. Typical failure mechanisms include tissue damage and implant detachment due to bacteria generated biofilm.

Hip replacement failure

Hip replacement implants can fail. Outcomes are normally recorded in a joint replacement registry to ensure patterns are picked up upon.

In 2013 Johnson & Johnson shared documents which indicated that 40% of a class of hip replacement implants which it manufactured had failed. [1]

Pacemaker failure

Pacemaker failure is the inability of an implanted artificial pacemaker to perform its intended function of regulating the beating of the heart. It is defined by the requirement of repeat surgical pacemaker-related procedure after the initial implantation. Causes of pacemaker failure included: lead related failure (lead migration, lead fracture, ventricular perforation), unit malfunction (battery failure or component malfunction), problems at the insertion site (infections, tissue breakdown, battery pack migration), and failures related to exposure to high voltage electricity or high intensity microwaves.[ citation needed ]

Cochlear implant failure

Cochlear implants are used to treat severe to profound hearing loss by electrically stimulating the hearing nerve. Clinical symptoms of cochlear implant failure include auditory symptoms (tinnitus, buzzing, roaring, popping sounds), non-auditory symptoms (pain, shocking sensation, burning sensation, facial stimulation, itching), and decrease in the patient's hearing performance. [2] When such symptoms occur, the patient's clinical team evaluates the patient and the device using in-situ methods, and determines if revision surgery is necessary. The most commonly reported device failures are due to impacts, loss of hermeticity, and electrode lead malfunctions. Most manufacturers provide on their websites the survival rate of their marketed implants, although they are not required to do so. In order to improve and standardize failure reporting practices to the public, the AAMI is developing an American standard for cochlear implants in collaboration with the FDA, major cochlear implant manufacturers, the CALCE center for reliability, doctors, and clinicians. [3]

Dental implant failure

Failure of a dental implant is often related to the failure of the implant to osseointegrate correctly with the bone, or vice versa. [4] [5] A dental implant is considered to be a failure if it is lost, mobile or shows peri-implant (around the implant) bone loss of greater than 1.0 mm in the first year and greater than 0.2 mm a year after. [6]

Dental implant failures have been studied. [7] Persons who smoke habitually prior to having dental implants are significantly more likely to have their implants fail. [8] Individuals who have diabetes and those who disregard general oral hygiene are also at higher risk of having their implants fail.

Responses to implant failure

In 2012 Royal College of Surgeons of England and the British Orthopaedic Association called for increased regulation of implants to prevent implant failure. [9]

A 2011 study by Dr. Diana Zuckerman and Paul Brown of the National Research Center for Women and Families, and Dr. Steven Nissen of the Cleveland Clinic, published in the Archives of Internal Medicine, showed that most medical devices recalled in the last five years for "serious health problems or death" had been previously approved by the FDA using the less stringent, and cheaper, 510(k) process. In a few cases the devices had been deemed so low-risk that they did not need FDA regulation. Of the 113 devices recalled, 35 were for cardiovascular issues. [10] This may lead to a reevaluation of FDA procedures and better oversight.

Related Research Articles

Artificial cardiac pacemaker Medical device

A cardiac pacemaker is a medical device that generates electrical impulses delivered by electrodes to cause the heart muscle chambers to contract and therefore pump blood. By doing so, this device replaces and/or regulates the function of the electrical conduction system of the heart.

Implantable cardioverter-defibrillator Medical device

An implantable cardioverter-defibrillator (ICD) or automated implantable cardioverter defibrillator (AICD) is a device implantable inside the body, able to perform defibrillation, and depending on the type, cardioversion and pacing of the heart. The ICD is the first-line treatment and prophylactic therapy for patients at risk for sudden cardiac death due to ventricular fibrillation and ventricular tachycardia.

Infective endocarditis Medical condition

Infective endocarditis is an infection of the inner surface of the heart, usually the valves. Signs and symptoms may include fever, small areas of bleeding into the skin, heart murmur, feeling tired, and low red blood cell count. Complications may include backward blood flow in the heart, heart failure – the heart struggling to pump a sufficient amount of blood to meet the body's needs, abnormal electrical conduction in the heart, stroke, and kidney failure.

Dental implant Surgical component that interfaces with the bone of the jaw

A dental implant is a prosthesis that interfaces with the bone of the jaw or skull to support a dental prosthesis such as a crown, bridge, denture, or facial prosthesis or to act as an orthodontic anchor. The basis for modern dental implants is a biologic process called osseointegration, in which materials such as titanium or zirconia form an intimate bond to bone. The implant fixture is first placed so that it is likely to osseointegrate, then a dental prosthetic is added. A variable amount of healing time is required for osseointegration before either the dental prosthetic is attached to the implant or an abutment is placed which will hold a dental prosthetic/crown.

Osseointegration is the direct structural and functional connection between living bone and the surface of a load-bearing artificial implant. A more recent definition defines osseointegration as "functional ankylosis ", where new bone is laid down directly on the implant surface and the implant exhibits mechanical stability. Osseointegration has enhanced the science of medical bone and joint replacement techniques as well as dental implants and improving prosthetics for amputees.

Medical device Device to be used for medical purposes

A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.

Implant (medicine) Device surgically placed within the body for medical purposes

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.

Dental plaque is a biofilm of microorganisms that grows on surfaces within the mouth. It is a sticky colorless deposit at first, but when it forms tartar, it is often brown or pale yellow. It is commonly found between the teeth, on the front of teeth, behind teeth, on chewing surfaces, along the gumline (supragingival), or below the gumline cervical margins (subgingival). Dental plaque is also known as microbial plaque, oral biofilm, dental biofilm, dental plaque biofilm or bacterial plaque biofilm. Bacterial plaque is one of the major causes for dental decay and gum disease.

Ventricular assist device

A ventricular assist device (VAD) is an electromechanical device for assisting cardiac circulation, which is used either to partially or to completely replace the function of a failing heart. The function of a VAD differs from that of an artificial cardiac pacemaker in that a VAD pumps blood, whereas a pacemaker delivers electrical impulses to the heart muscle. Some VADs are for short-term use, typically for patients recovering from myocardial infarction and for patients recovering from cardiac surgery; some are for long-term use, typically for patients with advanced heart failure.

Sinus lift

Maxillary sinus floor augmentation is a surgical procedure which aims to increase the amount of bone in the posterior maxilla, in the area of the premolar and molar teeth, by lifting the lower Schneiderian membrane and placing a bone graft.

Oral and maxillofacial pathology refers to the diseases of the mouth, jaws and related structures such as salivary glands, temporomandibular joints, facial muscles and perioral skin. The mouth is an important organ with many different functions. It is also prone to a variety of medical and dental disorders.

Medication-related osteonecrosis of the jaw Medical condition

Medication-related osteonecrosis of the jaw is progressive death of the jawbone in a person exposed to a medications known to increase the risk of disease, in the absence of a previous radiation treatment. It may lead to surgical complication in the form of impaired wound healing following oral and maxillofacial surgery, periodontal surgery, or endodontic therapy.

Gingivitis Inflammation of the gums

Gingivitis is a non-destructive disease that causes inflammation of the gums. The most common form of gingivitis, and the most common form of periodontal disease overall, is in response to bacterial biofilms that is attached to tooth surfaces, termed plaque-induced gingivitis. Most forms of gingivitis are plaque-induced.

Pacemaker failure is the inability of an implanted artificial pacemaker to perform its intended function of regulating the beating of the heart. A pacemaker uses electrical impulses delivered by electrodes in order to contract the heart muscles. Failure of a pacemaker is defined by the requirement of repeat surgical pacemaker-related procedures after the initial implantation. Most implanted pacemakers are dual chambered and have two leads, causing the implantation time to take longer because of this more complicated pacemaker system. These factors can contribute to an increased rate of complications which can lead to pacemaker failure.

Peri-implantitis

Peri-implantitis is a destructive inflammatory process affecting the soft and hard tissues surrounding dental implants. The soft tissues become inflamed whereas the alveolar bone, which surrounds the implant for the purposes of retention, is lost over time.

Cone beam computed tomography

Cone beam computed tomography is a medical imaging technique consisting of X-ray computed tomography where the X-rays are divergent, forming a cone.

Peri-implant mucositis is defined as an inflammatory lesion of the peri-implant mucosa in the absence of continuing marginal bone loss.

Cardiac contractility modulation is a therapy which is intended for the treatment of patients with moderate to severe heart failure with symptoms despite optimal medical therapy who can benefit from an improvement in cardiac output. The short- and long-term use of this therapy enhances the strength of ventricular contraction and therefore the heart's pumping capacity by modulating (adjusting) the myocardial contractility. This is provided by a pacemaker-like device that applies non-excitatory electrical signals adjusted to and synchronized with the electrical action in the cardiac cycle.

Attempts in the last decade to develop surgical treatments based on MRI and CAT scans now receive less attention. These techniques are reserved for the most difficult cases where other therapeutic modalities have failed. The American Society of Maxillofacial Surgeons recommends a conservative/non-surgical approach first. Only 20% of patients need to proceed to surgery.

A root-analog dental implant (RAI) – also known as a truly anatomic dental implant, or an anatomical/custom implant – is a medical device to replace one or more roots of a single tooth immediately after extraction. In contrast to common titanium screw type implants, these implants are custom-made to exactly match the extraction socket of the specific patient. Thus there is usually no need for surgery.

References

  1. ↑ Meier, Barry (22 January 2013). "Maker Aware of 40% Failure in Hip Implant - NYTimes.com". The New York Times . New York. ISSN   0362-4331 . Retrieved 5 June 2013.
  2. ↑ Balkany TJ; Hodges AV; Buchman CA; Luxford WM; Pillsbury CH; Roland PS; Shallop JK; Backous DD; Franz D; Graham JM; Hirsch B; Luntz M; Niparko JK; Patrick J; Payne SL; Telischi FF; Tobey EA; Truy E; Staller S (2005). "Cochlear implant soft failures consensus development conference statement". Otol. Neurotol. 26 (4): 815–8. doi:10.1097/01.mao.0000178150.44505.52. PMID   16015190. S2CID   23950969.
  3. ↑ "Association for the Advancement of Medical Instrumentation : CI - Cochlear Implants Committee". standards.aami.org. Archived from the original on 2014-07-12.
  4. ↑ Dental Implants Costs. 2021.
  5. ↑ Galagali, Girish; Reddy, E. Srinivas; Nidawani, Prakash; S P Behera, Sidhartha; Preetham, Pavan; Sarpangala, Mythri (January–March 2014). "Implant Failures: A Comprehensive Review" (PDF). International Journal of Preventive & Clinical Dental Research. 2014, 1(1): 11–17.
  6. ↑ Tissue-integrated prostheses :osseointegration in clinical dentistry, Per-Ingavar Branemark, George A. Zarb, Tomas Albrektsson, 1985
  7. ↑ Moy, P. K.; Medina, D.; Shetty, V.; Aghaloo, T. L. (2005). "Dental implant failure rates and associated risk factors". The International Journal of Oral & Maxillofacial Implants. 20 (4): 569–577. PMID   16161741.
  8. ↑ De Bruyn, H.; Collaert, B. (1994). "The effect of smoking on early implant failure". Clinical Oral Implants Research. 5 (4): 260–264. doi:10.1034/j.1600-0501.1994.050410.x. PMID   7640341.
  9. ↑ Watt, Holly; Newell, Claire (24 Oct 2012). "Faulty medical implants investigation: Patients failed by poor implant regulation, say surgeons - Telegraph". The Daily Telegraph . London. ISSN   0307-1235. OCLC   49632006. Archived from the original on 25 October 2012. Retrieved 5 June 2013.
  10. ↑ Zuckerman, Diana (2011). "Medical Device Recalls and the FDA Approval Process". Archives of Internal Medicine. 171 (11): 1006–11. doi: 10.1001/archinternmed.2011.30 . PMID   21321283.

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