An adhesion barrier is a medical implant that can be used to reduce abnormal internal

scar A scar (or scar tissue) is an area of fibrous tissue that replaces normal skin after an injury. Scars result from the biological process of wound repair in the skin, as well as in other organs, and tissues of the body. Thus, scarring is a n ...

ring (

adhesions Adhesions are fibrous bands that form between tissues and organs, often as a result of injury during surgery. They may be thought of as internal scar tissue that connects tissues not normally connected. Pathophysiology Adhesions form as a natural ...

) following surgery by separating the internal tissues and organs while they heal. Surgeons have realized that proper surgical technique is crucial to reduce adhesion formation. In addition, for more than a century,

adjuvants In pharmacology, an adjuvant is a drug or other substance, or a combination of substances, that is used to increase the efficacy#Pharmacology, efficacy or Potency (pharmacology), potency of certain drugs. Specifically, the term can refer to: * Adju ...

including drugs and materials such as animal membranes, gold foil,

mineral oil Mineral oil is any of various colorless, odorless, light mixtures of higher alkanes from a mineral source, particularly a distillate of petroleum, as distinct from usually edible vegetable oils. The name 'mineral oil' by itself is imprecise, ...

, sheets made of

rubber Rubber, also called India rubber, latex, Amazonian rubber, ''caucho'', or ''caoutchouc'', as initially produced, consists of polymers of the organic compound isoprene, with minor impurities of other organic compounds. Thailand, Malaysia, an ...

and

Teflon Polytetrafluoroethylene (PTFE) is a synthetic fluoropolymer of tetrafluoroethylene that has numerous applications. It is one of the best-known and widely applied PFAS. The commonly known brand name of PTFE-based composition is Teflon by Chemo ...

, have been used to reduce the risk of adhesion formation. Nevertheless, adhesions do occur and appear to be, to some degree, an almost unavoidable consequence of

abdominal The abdomen (colloquially called the belly, tummy, midriff, tucky or stomach) is the part of the body between the thorax (chest) and pelvis, in humans and in other vertebrates. The abdomen is the front part of the abdominal segment of the torso ...

and pelvic surgery. Adhesions can lead to significant post-surgical

morbidity A disease is a particular abnormal condition that negatively affects the structure or function of all or part of an organism, and that is not immediately due to any external injury. Diseases are often known to be medical conditions that a ...

, bowel obstruction, infertility, and

chronic pelvic pain Pelvic pain is pain in the area of the pelvis. Acute pain is more common than chronic pain. If the pain lasts for more than six months, it is deemed to be chronic pelvic pain. It can affect both the male and female pelvis. Common causes in inclu ...

or chronic

abdominal pain Abdominal pain, also known as a stomach ache, is a symptom associated with both non-serious and serious medical issues. Common causes of pain in the abdomen include gastroenteritis and irritable bowel syndrome. About 15% of people have a m ...

. Surgeons and

healthcare professional A health professional, healthcare professional, or healthcare worker (sometimes abbreviated HCW) is a provider of health care treatment and advice based on formal training and experience. The field includes those who work as a nurse, physician (s ...

s developed several methods for minimizing tissue injury in order to minimize the formation of adhesions. However, even an experienced surgeon despite using advanced techniques may not be able to fully prevent the formation of adhesions following surgery, without the aid of an adhesion barrier. Consequently, many surgeons apply adhesion barriers while performing abdominal and pelvic surgery. However, one study found the frequency of adhesion barrier use to be very low. The study examined hospital data and found that adhesion barriers were only used in a maximum of 5% of procedures in which the use of a barrier would be appropriate.

Description

Adhesion barriers are physical films,

fabric Textile is an umbrella term that includes various fiber-based materials, including fibers, yarns, filaments, threads, different fabric types, etc. At first, the word "textiles" only referred to woven fabrics. However, weaving is not th ...

gel A gel is a semi-solid that can have properties ranging from soft and weak to hard and tough. Gels are defined as a substantially dilute cross-linked system, which exhibits no flow when in the steady-state, although the liquid phase may still dif ...

s or other materials that are applied between layers of tissues at the end of a surgery before the incision site is closed. While in place, the adhesion barrier acts as a physical barrier to separate traumatized tissue surfaces so that they do not adhere to one another while the tissue surfaces heal. Once the tissue surfaces heal, which is usually between 3 and 7 days, the barrier dissolves and is absorbed by the body.

Commercial availability

Globa
Adhesion Barrier Market
Size is expected to reach US $ 15Mn by 2025 during the forecast period 2020 to 2025.The first commercially available adhesion barrier was probably Cargile Membrane, a preserved

peritoneal The peritoneum is the serous membrane forming the lining of the abdominal cavity or coelom in amniotes and some invertebrates, such as annelids. It covers most of the intra-abdominal (or coelomic) organs, and is composed of a layer of meso ...

membrane of the Danish Ox. Marketed by Johnson & Johnson around 1904, it was still available in the early 1990s. In the United States, Interceed, Seprafilm and Adept are the three products approved by the U.S.

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) for use as an adhesion barrier after abdominal or pelvic surgery. Seprafilm (made by

Genzyme Genzyme was an American biotechnology company based in Cambridge, Massachusetts. Since its acquisition in 2011, Genzyme (also known as Genzyme Transgenics Corp or GTC Biotherapeutics) has been a fully owned subsidiary of Sanofi. In 2010, Genzyme ...

) is a clear, sticky film composed of chemically modified sugars, some of which occur naturally in the human body. It sticks to the tissues to which it is applied and is slowly absorbed into the body over a period of seven days. It is approved for use in certain types of pelvic or abdominal surgery. Interceed (made by Johnson & Johnson) is a knitted fabric composed of a modified

cellulose Cellulose is an organic compound with the formula , a polysaccharide consisting of a linear chain of several hundred to many thousands of β(1→4) linked D-glucose units. Cellulose is an important structural component of the primary cell w ...

that swells and eventually gels after being placed on the injured site, and, like Seprafilm, forms a barrier and then is slowly absorbed over a period of days. It is approved for use in pelvic surgery. Although it is technically possible to apply either Seprafilm or Interceed

laparoscopically Laparoscopy () is an operation performed in the abdomen or human pelvis, pelvis using small Surgical incision, incisions (usually 0.5–1.5 cm) with the aid of a camera. The laparoscope aids diagnosis or therapeutic interventions with a few ...

, neither product is approved for this use in the U.S. Adept ( Baxter) is a solution of Icodextrin that when instilled in a large volume causes organs to float apart, reducing the possibility of attachment.

Other sources

A number of adhesion barriers are available outside of the United States including Hyalobarrier, SprayShield, PrevAdh and INTERCOAT. Several products licensed for other uses are used

off-label Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although ...

in the USA for adhesion prevention including Evicel, Surgiwrap, CoSeal and Preclude, the latter being a product of

Gore-Tex Gore-Tex is a waterproof, breathable fabric membrane and registered trademark of W. L. Gore & Associates. Invented in 1969, Gore-Tex can repel liquid water while allowing water vapor to pass through and is designed to be a lightweight, waterpr ...

, not being absorbed and requiring a second intervention/operation for removal. Products available for adhesion prevention outside the

and

pelvic The pelvis (plural pelves or pelvises) is the lower part of the trunk, between the abdomen and the thighs (sometimes also called pelvic region), together with its embedded skeleton (sometimes also called bony pelvis, or pelvic skeleton). The p ...

cavities inside or outside the U.S. include ADCON Gel (spine and tendon surgery), Sepragel ENT, INCERT (spine), Tenoglide (tendon), Oxiplex (Medishield) (spine) and REPEL CV (Cardiac). Genzyme also tested a spray-on barrier called Sepraspray. The company settled a federal Department of Justice lawsuit over claims its sales representatives illegally showed hospital staff how to dissolve Seprafilm with saline into "slurry" and use it in laproscopic surgeries, for which it was not FDA-approved.

Evaluation

According to Cochrane Summaries, Gore-Tex is more effective than Interceed, but requires a second surgery for removal as it is not absorbable. Seprafilm or Fibrin sheets were not found to be effective. Vigorous follow-up is crucial, thus more studies are needed in gynecologic surgery as a major drawback of studies is that they do not incorporate the gold standard of success, namely pregnancy rates.

References

External links