Implants and

Biomaterials
Dr. Rashid Khan
TMO
Plastic and Reconstructive Surgery
Date: 26/11/2015

Definition
The National Institutes of Health defines a biomaterial
as:
any substance (other than a drug) or combination of substances synthetic
or natural in origin, which can be used for any period of
time, as a whole or part of a system which treats, augments, or replaces
tissue, organ, or function of the body.

any material used in a medical device

intended to interact with biological
systems,

Historical Perspective
Biomaterials are being used by human
around 32000 years in the form sutures
Modern implants date back to 1940s, when
British opthalmologist unintentionally used
canopy plastic in Spitfire pilots eyes injuries
leading to its use in cataract surgery as
intraocular implants in 1949.
In 1950s Cumberland and Scales described
properties of an ideal implant

Classification
Biomaterials may be classified
according to:
1. Source
Synthetic , biological

2. Composition
Metals, polymers, ceramics, adhesives
& glues, skin substitutes

3. Host tissue responses

Bioinert, bioactive & bioresorbable

Requisites of ideal implant

Shape
Surface
Gap
Margins

Positioning
Supraperiosteal
Subperiosteal

Immobilization
Suture
Screw fixation

Biomaterials composition

Metals
Polymers
Ceramics
Adhesives and glues
Skin substitutes
Bioprosthetic mesh

Metals
Stainless steel:
Iron-chromium-nickel alloy, medical grade
316L.
Cr is protective component (conc 17%)
High tensile strength but easily deformed
Metallic ions leaching in tissues results
inflammatory reaction.
Used as surgical wire and arch bar in MMF.

Metals
Cobalt- Chromium:
Vitallium (Co-Cr-Mo alloy) first described in
1932
Co replace Fe of Stainless steel
Used in craniofacial miniplates and screws
Major disadvantage is scattered artifact on
CT
Replace by Titanium but still used in dental
implants

Metals
Titanium:

Introduced in medical applications in 1980

Replaced almost all other alloys
Stronger, lighter, less corrosive and less irritant
Less stress shielding due to less stiffness
Minimal artifact on CT / MRI
Can form bonds with surrounding bone without
typical fibrous tissue formation hence ideal for
osteointegrated implants
Plates and screws for rigid fixation and mesh
for orbit/skull reconstruction

Metals
Gold:
Chemically inert but poor mechanical
properties
Eyelid weight in lagopthalmos

Metals
Platinum:
Inert like gold but denser thus ideal eyelid
implant in lagopthalmos in patients with
gold sensitivity
Low profile and hence less noticeable
Some formulation may be immunogenic
Used as catalyst in manufacture of silicon
gel implant
Cisplatin, platinum chemotherapeutic agent

Polymers
Polymers are molecules of repeating
subunits
Backbone series of molecules
covalently bonded to side chains
Physical properties depends upon the
structure, number and cross linking
of monomers
Exist in liquid, gel and solid form

Polymers
Silicone:

First introduced in US in 1960

Most maligned and misunderstood biomaterial
Consists of alternating Si and O 2 molecules
Siloxane: combination of basic unit with a
saturated hydrocarbon side chain
Polydimethylsiloxane (PDMS)-{(CH 3)2SiO} is the
polymer used in most medical applications
Most inert material
Viscosity depends upon molecular weight

Silicone
Silicone implants are used in breast,
malar, nasal, chin
reconstruction/augmentation
Orbital floor reconstruction
Hand surgery; arthroplasty, flexor
tendons reconstruction, bone block
spacers
Used in medical devices
manufacturing, cosmetics

Polymers
Polytetraflouroethylene (PTFE)/ Teflon:

Invented in Roy Plunkett in 1938

Carbon backbone with flouride side chains
Porous (10-30 m), allows tissue in growth
Used as surgical meshes and vascular grafts

polymers
Polyester:
Contains an ester functional group
MERSILENE is polyster fiber mesh, used in
herniorrhaphy, more softer and hydrophilic
than polypropylene enhancing tissue
ingrowth
DACRON is another form of polyester used in
vascular graft

Polymers
Polypropylene:
Contains carbon back bone with side chains
of hydrogen and methyl groups
Used as polypropylene mesh and suture
High tensile strength with minimal tissue
reaction
Herniorhaphy and pelvic organ prolapse
surgery
Main complications are tissue/visceral
erosion and dense adhesions

Polymers
Polyethylene:
Contains carbon backbone with hydrogen
side chains
MEDPOR is highly dense porous form used in
facial implants
High tissue and vascular ingrowth making
placement and removal difficult
Along with titanium mesh used in orbital
floor reconstruction

Polymers
Biodegradable polymers:
Developed to overcome complication of
permanent implants
Degradation begins through hydrolysis or
oxidation
Mainly -hydroxy acids such as polyglycolic
acid and polylactic acid or their copolymers
named lactico-glycolic acid
Used as Vicryl suture and mesh
Biodegradable plates and screws in
craniofacial and hand surgery

Ceramics
Crystalline structure made up of inorganic and non metallic
molecules
Manufactured under high pressure and heat, the process called
Sintering.
Ceramics have decreased foreign body reaction, resisting bacterial
colonization, high compressive strength and tissue ingrowth
Main disadvantage, they are brittle and break easily undr tensile,
torsional and bending loads.
Bone augmentation and replacement
Calcium phosphate comes in two formulations hydroxyapatite
(Ca10(PO4)6(OH)2) and tricalcium phosphate (Ca 3(PO4) ).
TCP has better resorption and replacement rate by bone
Used in nonloading reconstruction of face and cranium
2

Adhesives and Glues

First fibrin tissue adhesive as
described in 1944 for skin graft
adherence and became commercially
available in 1978.
Cyanoacrylate was synthesized in
1949 but severe tissue reaction
limited its use.

Adhesives and Glues

Platelet Gels:
Derived from PRP
Platelet layer obtained from a 70ml
centrifuged whole blood is mixed with
bovine thrombin
Comercially available form has high conc of
fibrin and hence more effective but
expensive
Used in brow/facelift, abdominoplasty, LD
and TRAM flap donor sites.

Adhesives and Glues

Fibrin tissue adhesives:
Consists of two main components, fibrin and
thrombin, with small amount of factor XIII
and calcium
Dual syringe delivery system
(sprayer/mister) allow mixing at time of
application
Strength of fibrin glue is directly propotional
to fibrin concentration

Adhesives and Glues

Cyanoacrylate:
Original cyanoacrylate is butylcyanoacrylate, short chain with rapid break
down into formaldehyde and cyanoacetate
causing tissue irritation and wound
dehiscence
To overcome this long chain octylcyanoacrylate is developed
Skin closure in plastic surgery

Skin Substitutes
Bioengineered skin substitutes have
become mainstay in wound management
in past 20 years.
Management of severe burns, chronic
venous and diabetic ulcers
Three important component in
manufacturing
Cell source
Tissue differentiation inducer
matrix

Skin Substitutes
Integra:
Bilayer skin substitute
Dermal layer has bovine collagen base with
glycosaminoglycan chondroitin-6-sulphate
Upper/ epidermal layer is a silicone sheet

Indicated in superficial/fullthickness burns

and various types of ulcers
Integra has high rate of infection compare to
autograft. Allograft, xenograft or Biobrane
However it appears to be better in terms of
wound healing time 10- 14days

Epicel (cultured epidermal autografts):

Grown from patient own keratinocytes
through a small skin biopsy
Co cultured with 3T3 murine fibroblast
feeder cells
Once 2-8 cells thick it is insetted
Deep dermal or full thickness burns
involving more than 30% of TBSA
Epithelial cell combined with integra to
regenerate skin and oral mucosa

Dermagraft:
Polyglactin mesh seeded with neonatal
fiboblasts which produce collagen, GAG,
fibronectin and other growth factor
Mesh is resorb and replaced with human
tissue
Used for temporary and permanent covering
to inc successful take of meshed STSG in
burns, venous and diabetic ulcer
Equivalent to allograft

Apligraf:
Bilayered skin equivalent
Dermal layer contains bovines type 1 collagen
and fibroblasts obtained from neonatal foreskin
Epidermal layer has keratinocytes

Can be applied fresh with shelf life of 5 days

Mainly used in venous and diabtic ulcers but
can be used in conjunction with STSG in
excised burns

Bioprosthetic mesh
Derived from decellularised
mammalian tissue (allograft or
xenograft)
Dermis is most common source
It is developed to avoid the possible
side effect of synthetic prosthetic
mesh and provide more
biocompatible material
Limit adhesions, resist infection and
tolerate cutanuous exposure

Small intestine mucosa:

Also called Surgisis
Created from small intestinal mucosa of pigs
after removal of mucosal, muscular and
serosal layer
Durable yet biochemically rich and diverse
extracellular matrix
First described for vascular graft in 1989
Hernia repairs, dural repair, bladder
reconstruction and stress incontinence
treatmen

Human Acellular dermal matrix:

AlloDerm, AlloMax, FlexHD
Derived from donated human dermis which
is processed by freeze drying or chemical
detergents
Used in implant-based breast, abdominal
wall, chest wall and pelvic reconstruction,
and lip augmntation
Micronizd HADM (Cymetra) is used in
laryngoplasty and as soft tissue filler

Porcine acellular dermal matrix:

CollaMend , Prmacol , Strattice
More abundant but needs additional
processing to prevent immunogenic reaction
by chem cross linking of cllagen fibers or
enzymatic deactivation of antigen.

Other bioprosthetic mesh products:

Bovine pricardium (Veritas) is decellularised
and reduced immungenic collagen matrix
Bovine fetal dermis (Surgimend) is acellular
dermis derived from fetal calves

Future materials
Tissues specific response
Hybrid biomaterials containing cells,
polymers and growth factors thus
enabling them to sense their
surrounding and adopt to the needs
of environment