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An implant is a
medical device 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 assura ...
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 Biomedical tissue is biological tissue used for organ transplantation and medical research, particularly cancer research. When it is used for research it is a biological specimen. Such tissues and organs may be referred to as implant tissue, allogr ...
. The surface of implants that contact the body might be made of a biomedical material such as
titanium Titanium is a chemical element with the symbol Ti and atomic number 22. Found in nature only as an oxide, it can be reduced to produce a lustrous transition metal with a silver color, low density, and high strength, resistant to corrosion in ...
,
silicone A silicone or polysiloxane is a polymer made up of siloxane (−R2Si−O−SiR2−, where R = organic group). They are typically colorless oils or rubber-like substances. Silicones are used in sealants, adhesives, lubricants, medicine, cooking ...
, or
apatite Apatite is a group of phosphate minerals, usually hydroxyapatite, fluorapatite and chlorapatite, with high concentrations of OH−, F− and Cl− ions, respectively, in the crystal. The formula of the admixture of the three most common e ...
depending on what is the most functional. In some cases implants contain electronics, e.g.
artificial pacemaker An artificial cardiac pacemaker (or artificial pacemaker, so as not to be confused with the natural cardiac pacemaker) or pacemaker is a medical device that generates electrical impulses delivered by electrodes to the chambers of the heart eith ...
and
cochlear implant A cochlear implant (CI) is a surgically implanted neuroprosthesis that provides a person who has moderate-to-profound sensorineural hearing loss with sound perception. With the help of therapy, cochlear implants may allow for improved speech und ...
s. Some implants are bioactive, such as subcutaneous drug delivery devices in the form of implantable pills or
drug-eluting stent A drug-eluting stent (DES) is a peripheral or coronary stent (a scaffold) placed into narrowed, diseased peripheral or coronary arteries that slowly release a drug to block cell proliferation. This prevents fibrosis that, together with clots ...
s.


Applications

Implants can roughly be categorized into groups by application:


Sensory and neurological

Sensory and
neurological Neurology (from el, νεῦρον (neûron), "string, nerve" and the suffix -logia, "study of") is the branch of medicine dealing with the diagnosis and treatment of all categories of conditions and disease involving the brain, the spinal ...
implants are used for disorders affecting the major senses and the brain, as well as other neurological disorders. They are predominately used in the treatment of conditions such as
cataract A cataract is a cloudy area in the lens of the eye that leads to a decrease in vision. Cataracts often develop slowly and can affect one or both eyes. Symptoms may include faded colors, blurry or double vision, halos around light, trouble w ...
,
glaucoma Glaucoma is a group of eye diseases that result in damage to the optic nerve (or retina) and cause vision loss. The most common type is open-angle (wide angle, chronic simple) glaucoma, in which the drainage angle for fluid within the eye rem ...
,
keratoconus Keratoconus (KC) is a disorder of the eye that results in progressive thinning of the cornea. This may result in blurry vision, double vision, nearsightedness, irregular astigmatism, and light sensitivity leading to poor quality-of-life. Usu ...
, and other
visual impairment Visual impairment, also known as vision impairment, is a medical definition primarily measured based on an individual's better eye visual acuity; in the absence of treatment such as correctable eyewear, assistive devices, and medical treatment ...
s;
otosclerosis Otosclerosis is a condition of the middle ear where portions of the dense enchondral layer of the bony labyrinth remodel into one or more lesions of irregularly-laid spongy bone. As the lesions reach the stapes the bone is resorbed, then hardene ...
and other
hearing loss Hearing loss is a partial or total inability to Hearing, hear. Hearing loss may be present at birth or acquired at any time afterwards. Hearing loss may occur in one or both ears. In children, hearing problems can affect the ability to Language ...
issues, as well as
middle ear The middle ear is the portion of the ear medial to the eardrum, and distal to the oval window of the cochlea (of the inner ear). The mammalian middle ear contains three ossicles, which transfer the vibrations of the eardrum into waves in the ...
diseases such as
otitis media Otitis media is a group of inflammatory diseases of the middle ear. One of the two main types is acute otitis media (AOM), an infection of rapid onset that usually presents with ear pain. In young children this may result in pulling at the ear, ...
; and neurological diseases such as
epilepsy Epilepsy is a group of non-communicable neurological disorders characterized by recurrent epileptic seizures. Epileptic seizures can vary from brief and nearly undetectable periods to long periods of vigorous shaking due to abnormal electrical ...
,
Parkinson's disease Parkinson's disease (PD), or simply Parkinson's, is a long-term degenerative disorder of the central nervous system that mainly affects the motor system. The symptoms usually emerge slowly, and as the disease worsens, non-motor symptoms becom ...
, and
treatment-resistant depression Treatment-resistant depression is a term used in psychiatry to describe people with major depressive disorder (MDD) who do not respond adequately to a course of appropriate antidepressant medication within a certain time. Definitions of treatment- ...
. Examples include the
intraocular lens Intraocular lens (IOL) is a lens implanted in the eye as part of a treatment for cataracts or myopia. If the natural lens is left in the eye, the IOL is known as phakic, otherwise it is a pseudophakic, or false lens. Such a lens is typically i ...
,
intrastromal corneal ring segment An intrastromal corneal ring segment (ICRS) (also known as intrastromal corneal ring, corneal implant or corneal insert) is a small device implanted in the eye to correct vision. The procedure involves an ophthalmologist who makes a small incisio ...
,
cochlear implant A cochlear implant (CI) is a surgically implanted neuroprosthesis that provides a person who has moderate-to-profound sensorineural hearing loss with sound perception. With the help of therapy, cochlear implants may allow for improved speech und ...
,
tympanostomy tube Tympanostomy tube, also known as a grommet or myringotomy tube, is a small tube inserted into the eardrum in order to keep the middle ear aerated for a prolonged period of time, and to prevent the accumulation of fluid in the middle ear. The oper ...
, and
neurostimulator Neurostimulation is the purposeful modulation of the nervous system's activity using invasive (e.g. microelectrodes) or non-invasive means (e.g. transcranial magnetic stimulation or transcranial electric stimulation, tES, such as tDCS or transcr ...
.


Cardiovascular

Cardiovascular The blood circulatory system is a system of organs that includes the heart, blood vessels, and blood which is circulated throughout the entire body of a human or other vertebrate. It includes the cardiovascular system, or vascular system, tha ...
medical devices are implanted in cases where the heart, its
valves A valve is a device or natural object that regulates, directs or controls the flow of a fluid (gases, liquids, fluidized solids, or slurries) by opening, closing, or partially obstructing various passageways. Valves are technically fittings ...
, and the rest of the
circulatory system The blood circulatory system is a system of organs that includes the heart, blood vessels, and blood which is circulated throughout the entire body of a human or other vertebrate. It includes the cardiovascular system, or vascular system, tha ...
is in disorder. They are used to treat conditions such as
heart failure Heart failure (HF), also known as congestive heart failure (CHF), is a syndrome, a group of signs and symptoms caused by an impairment of the heart's blood pumping function. Symptoms typically include shortness of breath, excessive fatigue, a ...
,
cardiac arrhythmia Arrhythmias, also known as cardiac arrhythmias, heart arrhythmias, or dysrhythmias, are irregularities in the heartbeat, including when it is too fast or too slow. A resting heart rate that is too fast – above 100 beats per minute in adults ...
,
ventricular tachycardia Ventricular tachycardia (V-tach or VT) is a fast heart rate arising from the lower chambers of the heart. Although a few seconds of VT may not result in permanent problems, longer periods are dangerous; and multiple episodes over a short period ...
,
valvular heart disease Valvular heart disease is any cardiovascular disease process involving one or more of the four valves of the heart (the aortic and mitral valves on the left side of heart and the pulmonic and tricuspid valves on the right side of heart). These ...
,
angina pectoris Angina, also known as angina pectoris, is chest pain or pressure, usually caused by insufficient blood flow to the heart muscle (myocardium). It is most commonly a symptom of coronary artery disease. Angina is typically the result of obstru ...
, and
atherosclerosis Atherosclerosis is a pattern of the disease arteriosclerosis in which the wall of the artery develops abnormalities, called lesions. These lesions may lead to narrowing due to the buildup of atheroma, atheromatous plaque. At onset there are usu ...
. Examples include the
artificial heart An artificial heart is a device that replaces the heart. Artificial hearts are typically used to bridge the time to heart transplantation, or to permanently replace the heart in the case that a heart transplant (from a deceased human or, experi ...
,
artificial heart valve An artificial heart valve is a one-way valve implanted into a person's heart to replace a heart valve that is not functioning properly (valvular heart disease). Artificial heart valves can be separated into three broad classes: mechanical hear ...
,
implantable cardioverter-defibrillator 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 ...
,
artificial cardiac pacemaker An artificial cardiac pacemaker (or artificial pacemaker, so as not to be confused with the natural cardiac pacemaker) or pacemaker is a medical device that generates electrical impulses delivered by electrodes to the chambers of the heart ei ...
, and
coronary stent A coronary stent is a tube-shaped device placed in the coronary arteries that supply blood to the heart, to keep the arteries open in the treatment of coronary heart disease. It is used in a procedure called percutaneous coronary intervention (PC ...
.


Orthopedic

Orthopaedic Orthopedic surgery or orthopedics ( alternatively spelt orthopaedics), is the branch of surgery concerned with conditions involving the musculoskeletal system. Orthopedic surgeons use both surgical and nonsurgical means to treat musculoskeletal ...
implants help alleviate issues with the bones and joints of the body. They are used to treat
bone fracture A bone fracture (abbreviated FRX or Fx, Fx, or #) is a medical condition in which there is a partial or complete break in the continuity of any bone in the body. In more severe cases, the bone may be broken into several fragments, known as a '' ...
s,
osteoarthritis Osteoarthritis (OA) is a type of degenerative joint disease that results from breakdown of joint cartilage and underlying bone which affects 1 in 7 adults in the United States. It is believed to be the fourth leading cause of disability in the w ...
,
scoliosis Scoliosis is a condition in which a person's spine has a sideways curve. The curve is usually "S"- or "C"-shaped over three dimensions. In some, the degree of curve is stable, while in others, it increases over time. Mild scoliosis does not t ...
,
spinal stenosis Spinal stenosis is an abnormal narrowing of the spinal canal or neural foramen that results in pressure on the spinal cord or nerve roots. Symptoms may include pain, numbness, or weakness in the arms or legs. Symptoms are typically gradual in on ...
, and
chronic pain Chronic pain is classified as pain that lasts longer than three to six months. In medicine, the distinction between Acute (medicine), acute and Chronic condition, chronic pain is sometimes determined by the amount of time since onset. Two commonly ...
. Examples include a wide variety of pins, rods, screws, and plates used to anchor fractured bones while they heal. Metallic glasses based on magnesium with zinc and calcium addition are tested as the potential metallic biomaterials for biodegradable medical implants. Patient with orthopaedic implants sometimes need to be put under
magnetic resonance imaging Magnetic resonance imaging (MRI) is a medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body. MRI scanners use strong magnetic fields, magnetic field gradients, and radio wave ...
(MRI) machine for detailed musculoskeletal study. Therefore, concerns have been raised regarding the loosening and migration of implant, heating of the implant metal which could cause thermal damage to surrounding tissues, and distortion of the MRI scan that affects the imaging results. A study of orthopaedic implants in 2005 has shown that majority of the orthopaedic implants does not react with magnetic fields under the 1.0 Tesla MRI scanning machine with the exception of external fixator clamps. However, at 7.0 Tesla, several orthopaedic implants would show significant interaction with the MRI magnetic fields, such as
heel The heel is the prominence at the posterior end of the foot. It is based on the projection of one bone, the calcaneus or heel bone, behind the articulation of the bones of the lower Human leg, leg. Structure To distribute the compressive for ...
and
fibula The fibula or calf bone is a leg bone on the lateral side of the tibia, to which it is connected above and below. It is the smaller of the two bones and, in proportion to its length, the most slender of all the long bones. Its upper extremity is ...
r implant.


Electric

Electrical implants are being used to relieve pain from
rheumatoid arthritis Rheumatoid arthritis (RA) is a long-term autoimmune disorder that primarily affects joints. It typically results in warm, swollen, and painful joints. Pain and stiffness often worsen following rest. Most commonly, the wrist and hands are involv ...
. The electric implant is embedded in the neck of patients with rheumatoid arthritics, the implant sends electrical signals to electrodes in the
vagus nerve The vagus nerve, also known as the tenth cranial nerve, cranial nerve X, or simply CN X, is a cranial nerve that interfaces with the parasympathetic control of the heart, lungs, and digestive tract. It comprises two nerves—the left and right ...
. The application of this device is being tested an alternative to medicating people with rheumatoid arthritis for their lifetime.


Contraception

Contraceptive Birth control, also known as contraception, anticonception, and fertility control, is the use of methods or devices to prevent unwanted pregnancy. Birth control has been used since ancient times, but effective and safe methods of birth contr ...
implants are primarily used to prevent
unintended pregnancy Unintended pregnancies are pregnancies that are mistimed, unplanned or unwanted at the time of conception. Sexual activity without the use of effective contraception through choice or coercion is the predominant cause of unintended pregnancy. Wor ...
and treat conditions such as non-pathological forms of
menorrhagia Heavy menstrual bleeding (HMB), previously known as menorrhagia or hypermenorrhea, is a menstrual period with excessively heavy flow. It is a type of abnormal uterine bleeding Abnormal uterine bleeding (AUB), also known as (AVB) or as atypical ...
. Examples include
copper Copper is a chemical element with the symbol Cu (from la, cuprum) and atomic number 29. It is a soft, malleable, and ductile metal with very high thermal and electrical conductivity. A freshly exposed surface of pure copper has a pinkis ...
- and
hormone A hormone (from the Greek participle , "setting in motion") is a class of signaling molecules in multicellular organisms that are sent to distant organs by complex biological processes to regulate physiology and behavior. Hormones are required ...
-based
intrauterine device An intrauterine device (IUD), also known as intrauterine contraceptive device (IUCD or ICD) or coil, is a small, often T-shaped birth control device that is inserted into the uterus to prevent pregnancy. IUDs are one form of long-acting rever ...
s.


Cosmetic

Cosmetic Cosmetic may refer to: *Cosmetics, or make-up, substances to enhance the beauty of the human body, apart from simple cleaning *Cosmetic, an adjective describing beauty, aesthetics, or appearance, especially concerning the human body *Cosmetic, a t ...
implants — often
prosthetics In medicine, a prosthesis (plural: prostheses; from grc, πρόσθεσις, prósthesis, addition, application, attachment), or a prosthetic implant, is an artificial device that replaces a missing body part, which may be lost through trau ...
— attempt to bring some portion of the body back to an acceptable aesthetic norm. They are used as a follow-up to
mastectomy Mastectomy is the medical term for the surgical removal of one or both breasts, partially or completely. A mastectomy is usually carried out to treat breast cancer. In some cases, women believed to be at high risk of breast cancer have the operat ...
due to
breast cancer Breast cancer is cancer that develops from breast tissue. Signs of breast cancer may include a lump in the breast, a change in breast shape, dimpling of the skin, milk rejection, fluid coming from the nipple, a newly inverted nipple, or a re ...
, for correcting some forms of
disfigurement Disfigurement is the state of having one's appearance deeply and persistently harmed medically, such as from a disease, birth defect, or wound. General societal attitudes towards disfigurement have varied greatly across cultures and over time, ...
, and modifying aspects of the body (as in
buttock augmentation Gluteoplasty (Greek ''gloutόs'', rump + ''plassein'', to shape) denotes the plastic surgery and the liposuction procedures for the correction of the congenital, traumatic, and acquired defects and deformities of the buttocks and the anatomy o ...
and
chin augmentation Chin augmentation using surgical implants can alter the underlying structure of the face, providing better balance to the facial features. The specific medical terms mentoplasty and genioplasty are used to refer to the reduction and addition of ma ...
). Examples include the
breast implant A breast implant is a prosthesis used to change the size, shape, and contour of a person's breast. In reconstructive plastic surgery, breast implants can be placed to restore a natural looking breast following a mastectomy, to correct congenital ...
,
nose prosthesis A nose prosthesis is a craniofacial prosthesis for someone who no longer has their original nose. Nose prostheses are designed by anaplastologists who have their patients referred to them by ear, nose, and throat doctors and plastic surgeons. Un ...
,
ocular prosthesis An ocular prosthesis, artificial eye or glass eye is a type of craniofacial prosthesis that replaces an absent natural eye following an enucleation, evisceration, or orbital exenteration. The prosthesis fits over an orbital implant and under ...
, and
injectable filler Injectable filler (injectable cosmetic filler, injectable facial filler) is a soft tissue filler injected into the skin at different depths to help fill in facial wrinkles, provide facial volume, and augment facial features: restoring a smoother ap ...
.


Other organs and systems

Other types of
organ dysfunction Organ dysfunction is a condition where an Organ (anatomy), organ does not perform its expected function. Organ failure is organ dysfunction to such a degree that normal homeostasis cannot be maintained without external clinical intervention. It i ...
can occur in the systems of the body, including the
gastrointestinal The gastrointestinal tract (GI tract, digestive tract, alimentary canal) is the tract or passageway of the digestive system that leads from the mouth to the anus. The GI tract contains all the major organs of the digestive system, in humans and ...
,
respiratory The respiratory system (also respiratory apparatus, ventilatory system) is a biological system consisting of specific organs and structures used for gas exchange in animals and plants. The anatomy and physiology that make this happen varies grea ...
, and
urological Urology (from Greek οὖρον ''ouron'' "urine" and ''-logia'' "study of"), also known as genitourinary surgery, is the branch of medicine that focuses on surgical and medical diseases of the urinary-tract system and the reproductive organ ...
systems. Implants are used in those and other locations to treat conditions such as
gastroesophageal reflux disease Gastroesophageal reflux disease (GERD) or gastro-oesophageal reflux disease (GORD) is one of the upper gastrointestinal chronic diseases where stomach content persistently and regularly flows up into the esophagus, resulting in symptoms and/ ...
,
gastroparesis Gastroparesis (gastro- from Ancient Greek γαστήρ – gaster, "stomach"; and -paresis, πάρεσις – "partial paralysis"), also called delayed gastric emptying, is a medical disorder consisting of weak muscular contractions (peristalsis) ...
,
respiratory failure Respiratory failure results from inadequate gas exchange by the respiratory system, meaning that the arterial oxygen, carbon dioxide, or both cannot be kept at normal levels. A drop in the oxygen carried in the blood is known as hypoxemia; a rise ...
,
sleep apnea Sleep apnea, also spelled sleep apnoea, is a sleep disorder in which pauses in breathing or periods of shallow breathing during sleep occur more often than normal. Each pause can last for a few seconds to a few minutes and they happen many times ...
,
urinary The urinary system, also known as the urinary tract or renal system, consists of the kidneys, ureters, bladder, and the urethra. The purpose of the urinary system is to eliminate waste from the body, regulate blood volume and blood pressure, con ...
and
fecal incontinence Fecal incontinence (FI), or in some forms encopresis, is a lack of control over defecation, leading to involuntary loss of bowel contents, both liquid stool elements and mucus, or solid feces. When this loss includes flatus (gas), it is referred ...
, and
erectile dysfunction Erectile dysfunction (ED), also called impotence, is the type of sexual dysfunction in which the penis fails to become or stay erect during sexual activity. It is the most common sexual problem in men.Cunningham GR, Rosen RC. Overview of male ...
. Examples include the
LINX Linx or LINX may refer to: * Linx Cargo Care Group, Australian logistics company * Linx (railway company), a now defunct Norwegian-Swedish railway company * Linx (software house), a Brazilian business management software company * LINX (IPC), an ...
, implantable gastric stimulator, diaphragmatic/phrenic nerve stimulator, neurostimulator,
surgical mesh Surgical mesh is a loosely woven sheet which is used as either a permanent or temporary support for organs and other tissues during surgery. Surgical mesh is created from both inorganic and biological materials and is used in a variety of surg ...
,
artificial urinary sphincter An artificial urinary sphincter (AUS) is an implanted device to treat moderate to severe stress urinary incontinence, most commonly in men. The AUS is designed to supplement the function of the natural urinary sphincter that restricts urine flo ...
and
penile implant A penile implant is an implanted device intended for the treatment of erectile dysfunction, Peyronie's disease, ischemic priapism, deformity and any traumatic injury of the penis, and for phalloplasty or metoidioplasty, including in gender-affi ...
.


Classification


United States classification

Medical devices 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 assura ...
are classified by the US
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA) under three different classes depending on the risks the medical device may impose on the user. According to 21CFR 860.3, 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 A surgical instrument is a tool or device for performing specific actions or carrying out desired effects during a surgery or operation, such as modifying biological tissue, or to provide access for viewing it. Over time, many different kinds of ...
. 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 A heart valve is a one-way valve that allows blood to flow in one direction through the chambers of the heart. Four valves are usually present in a mammalian heart and together they determine the pathway of blood flow through the heart. A heart v ...
and implanted
cerebellar The cerebellum (Latin for "little brain") is a major feature of the hindbrain of all vertebrates. Although usually smaller than the cerebrum, in some animals such as the mormyrid fishes it may be as large as or even larger. In humans, the cerebel ...
stimulators. Many implants typically fall under Class II and Class III devices.


Materials


Commonly implanted metals

A variety of minimally bioreactive metals are routinely implanted. The most commonly implanted form of
stainless steel Stainless steel is an alloy of iron that is resistant to rusting and corrosion. It contains at least 11% chromium and may contain elements such as carbon, other nonmetals and metals to obtain other desired properties. Stainless steel's corros ...
is
316L SAE 316L grade stainless steel, sometimes referred to as A4 stainless steel or marine grade stainless steel, is the second most common austenitic stainless steel after 304/A2 stainless steel. Its primary alloying constituents after iron, are c ...
.
Cobalt Cobalt is a chemical element with the symbol Co and atomic number 27. As with nickel, cobalt is found in the Earth's crust only in a chemically combined form, save for small deposits found in alloys of natural meteoric iron. The free element, pr ...
-
chromium Chromium is a chemical element with the symbol Cr and atomic number 24. It is the first element in group 6. It is a steely-grey, lustrous, hard, and brittle transition metal. Chromium metal is valued for its high corrosion resistance and hardne ...
and
titanium Titanium is a chemical element with the symbol Ti and atomic number 22. Found in nature only as an oxide, it can be reduced to produce a lustrous transition metal with a silver color, low density, and high strength, resistant to corrosion in ...
-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 Stainless steel is an alloy of iron that is resistant to rusting and corrosion. It contains at least 11% chromium and may contain elements such as carbon, other nonmetals and metals to obtain other desired properties. Stainless steel's corros ...

* ASTM F138/F139
316L SAE 316L grade stainless steel, sometimes referred to as A4 stainless steel or marine grade stainless steel, is the second most common austenitic stainless steel after 304/A2 stainless steel. Its primary alloying constituents after iron, are c ...
* ASTM F1314 22Cr-13Ni–5Mn


Titanium Alloy Titanium alloys are alloys that contain a mixture of titanium and other chemical elements. Such alloys have very high tensile strength and toughness (even at extreme temperatures). They are light in weight, have extraordinary corrosion resistance a ...

* ASTM F67 Unalloyed (Commercially Pure)
Titanium Titanium is a chemical element with the symbol Ti and atomic number 22. Found in nature only as an oxide, it can be reduced to produce a lustrous transition metal with a silver color, low density, and high strength, resistant to corrosion in ...
* ASTM F136 Ti-6Al-4V-ELI * ASTM F1295
Ti-6Al-7Nb Ti-6Al-7Nb (UNS designation R56700) is an alpha-beta titanium alloy first synthesized in 1977 containing 6% aluminum and 7% niobium. It features high strength and has similar properties as the cytotoxic vanadium containing alloy Ti-6Al-4V. Ti-6Al-7N ...
* ASTM F1472
Ti-6Al-4V Ti-6Al-4V (UNS designation R56400), also sometimes called TC4, Ti64, or ASTM Grade 5, is an alpha-beta titanium alloy with a high specific strength and excellent corrosion resistance. It is one of the most commonly used titanium alloys and is applie ...


Cobalt Chrome Alloy

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


Tantalum

* ASTM F560 Unalloyed
Tantalum Tantalum is a chemical element with the symbol Ta and atomic number 73. Previously known as ''tantalium'', it is named after Tantalus, a villain in Greek mythology. Tantalum is a very hard, ductile, lustrous, blue-gray transition metal that is ...


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 Stress shielding is the reduction in bone density (osteopenia) as a result of removal of typical stress from the bone by an implant (for instance, the femoral component of a hip prosthesis). This is because by Wolff's law Wolff's law, developed ...
. 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

Under ideal conditions, implants should initiate the desired
host response The immune system is a network of biological processes that protects an organism from diseases. It detects and responds to a wide variety of pathogens, from viruses to parasitic worms, as well as cancer cells and objects such as wood splinte ...
. 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 An infection is the invasion of tissues by pathogens, their multiplication, and the reaction of host tissues to the infectious agent and the toxins they produce. An infectious disease, also known as a transmissible disease or communicable dise ...
,
inflammation Inflammation (from la, wikt:en:inflammatio#Latin, inflammatio) is part of the complex biological response of body tissues to harmful stimuli, such as pathogens, damaged cells, or Irritation, irritants, and is a protective response involving im ...
, and
pain Pain is a distressing feeling often caused by intense or damaging stimuli. The International Association for the Study of Pain defines pain as "an unpleasant sensory and emotional experience associated with, or resembling that associated with, ...
. Other complications that can occur include risk of rejection from implant-induced
coagulation Coagulation, also known as clotting, is the process by which blood changes from a liquid to a gel, forming a blood clot. It potentially results in hemostasis, the cessation of blood loss from a damaged vessel, followed by repair. The mechanism o ...
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 A microorganism, or microbe,, ''mikros'', "small") and ''organism'' from the el, ὀργανισμός, ''organismós'', "organism"). It is usually written as a single word but is sometimes hyphenated (''micro-organism''), especially in olde ...
. 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 Bacteria (; singular: bacterium) are ubiquitous, mostly free-living organisms often consisting of one biological cell. They constitute a large domain of prokaryotic microorganisms. Typically a few micrometres in length, bacteria were among ...
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
antibiotic An antibiotic is a type of antimicrobial substance active against bacteria. It is the most important type of antibacterial agent for fighting bacterial infections, and antibiotic medications are widely used in the treatment and prevention of ...
s 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 Cell death is the event of a biological cell ceasing to carry out its functions. This may be the result of the natural process of old cells dying and being replaced by new ones, as in programmed cell death, or may result from factors such as dis ...
, or as a part of an
immune response An immune response is a reaction which occurs within an organism for the purpose of defending against foreign invaders. These invaders include a wide variety of different microorganisms including viruses, bacteria, parasites, and fungi which could ...
. Inflammation starts with the rapid dilation of local
capillaries A capillary is a small blood vessel from 5 to 10 micrometres (μm) in diameter. Capillaries are composed of only the tunica intima, consisting of a thin wall of simple squamous endothelial cells. They are the smallest blood vessels in the body: ...
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
protein Proteins are large biomolecules and macromolecules that comprise one or more long chains of amino acid residues. Proteins perform a vast array of functions within organisms, including catalysing metabolic reactions, DNA replication, respo ...
s 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 Fibrinogen (factor I) is a glycoprotein complex, produced in the liver, that circulates in the blood of all vertebrates. During tissue and vascular injury, it is converted enzymatically by thrombin to fibrin and then to a fibrin-based blood clo ...
and
platelet Platelets, also called thrombocytes (from Greek θρόμβος, "clot" and κύτος, "cell"), are a component of blood whose function (along with the coagulation factors) is to react to bleeding from blood vessel injury by clumping, thereby ini ...
s. 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 failure 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 impl ...
include
rupture Rupture may refer to: General * Rupture (engineering), a failure of tough ductile materials loaded in tension Anatomy and medicine * Abdominal hernia, formerly referred to as "a rupture" * Achilles tendon rupture * Rupture of membranes, a "wate ...
of silicone
breast implant A breast implant is a prosthesis used to change the size, shape, and contour of a person's breast. In reconstructive plastic surgery, breast implants can be placed to restore a natural looking breast following a mastectomy, to correct congenital ...
s,
hip replacement Hip replacement is a surgical procedure in which the hip joint is replaced by a prosthetic implant, that is, a hip prosthesis. Hip replacement surgery can be performed as a total replacement or a hemi (half) replacement. Such joint replacement o ...
joints, and
artificial heart valves An artificial heart valve is a one-way valve implanted into a person's heart to replace a heart valve that is not functioning properly (valvular heart disease). Artificial heart valves can be separated into three broad classes: mechanical hear ...
, 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 Grey matter is a major component of the central nervous system, consisting of neuronal cell bodies, neuropil (dendrites and unmyelinated axons), glial cells (astrocytes and oligodendrocytes), synapses, and capillaries. Grey matter is distingui ...
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 The International Consortium of Investigative Journalists, Inc. (ICIJ), is an independent global network of 280 investigative journalists and over 140 media organizations spanning more than 100 countries. It is based in Washington, D.C. with pe ...
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 The Royal College of Surgeons is an ancient college (a form of corporation) established in England to regulate the activity of surgeons. Derivative organisations survive in many present and former members of the Commonwealth. These organisations a ...
, concludes: "All implantable devices should be registered and tracked to monitor efficacy and patient safety in the long-term."


See also

*
Biofunctionalisation In the field of bioengineering, biofunctionalisation (or biofunctionalization) is the modification of a material to have biological function and/or stimulus A stimulus is something that causes a physiological response. It may refer to: *Stimulat ...
* Implantable devices *
List of orthopedic implants An orthopedic implant is a medical device manufactured to replace a missing joint or bone or to support a damaged bone. The medical implant is mainly fabricated using stainless steel and titanium alloys for strength and the plastic coating that is ...
*
Medical device 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 assura ...
*
Prosthesis In medicine, a prosthesis (plural: prostheses; from grc, πρόσθεσις, prósthesis, addition, application, attachment), or a prosthetic implant, is an artificial device that replaces a missing body part, which may be lost through trau ...
* Microchip implant * Implant Files scandal by
ICIJ The International Consortium of Investigative Journalists, Inc. (ICIJ), is an independent global network of 280 investigative journalists and over 140 media organizations spanning more than 100 countries. It is based in Washington, D.C. with pe ...
, November 2018.


References


External links


AAOMS - Dental Implant Surgery

ACOG - IUDs and Birth Control Implants: Resource Overview

International Medical Devices Database
– Recalls, Safety Alerts and Field Safety Notices of medical devices –
International Consortium of Investigative Journalists The International Consortium of Investigative Journalists, Inc. (ICIJ), is an independent global network of 280 investigative journalists and over 140 media organizations spanning more than 100 countries. It is based in Washington, D.C. with pe ...

Implant-Register
{{Authority control Biomedical engineering Prosthetics Tissue engineering