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 fibrosis, 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 Organ (anatomy), organs, and biological tissue, t ...

ring ( adhesions) following

surgery Surgery is a medical specialty that uses manual and instrumental techniques to diagnose or treat pathological conditions (e.g., trauma, disease, injury, malignancy), to alter bodily functions (e.g., malabsorption created by bariatric surgery s ...

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 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. Types of polyisoprene ...

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

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

bowel obstruction Bowel obstruction, also known as intestinal obstruction, is a mechanical or Ileus, functional obstruction of the Gastrointestinal tract#Lower gastrointestinal tract, intestines which prevents the normal movement of the products of digestion. Ei ...

infertility In biology, infertility is the inability of a male and female organism to Sexual reproduction, reproduce. It is usually not the natural state of a healthy organism that has reached sexual maturity, so children who have not undergone puberty, whi ...

, 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 include ...

or chronic

abdominal pain Abdominal pain, also known as a stomach ache, is a symptom associated with both non-serious and serious medical issues. Since the abdomen contains most of the body's vital organs, it can be an indicator of a wide variety of diseases. Given th ...

. Surgeons and healthcare professionals 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, and different types of fabric. At first, the word "textiles" only referred to woven fabrics. However, weaving is no ...

s, gels 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 membrane of the Danish Ox. Marketed by

Johnson & Johnson Johnson & Johnson (J&J) is an American multinational pharmaceutical, biotechnology, and medical technologies corporation headquartered in New Brunswick, New Jersey, and publicly traded on the New York Stock Exchange. Its common stock is a c ...

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 respo ...

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

Genzyme Genzyme (also known as Genzyme Transgenics Corp or GTC Biotherapeutics) was an American biotechnology company based in Cambridge, Massachusetts. From its acquisition in 2011 to 2022 Genzyme operated as a fully owned subsidiary of Sanofi. In 2010, ...

) is a clear, sticky film composed of chemically modified

sugar Sugar is the generic name for sweet-tasting, soluble carbohydrates, many of which are used in food. Simple sugars, also called monosaccharides, include glucose Glucose is a sugar with the Chemical formula#Molecular formula, molecul ...

s, 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

) is a

knitted fabric Knitted fabric is a textile that results from knitting, the process of inter-looping of yarns or inter-meshing of loops. Its properties are distinct from woven fabric in that it is more flexible and can be more readily constructed into smaller ...

composed of a modified

cellulose Cellulose is an organic compound with the chemical formula, formula , a polysaccharide consisting of a linear chain of several hundred to many thousands of glycosidic bond, β(1→4) linked glucose, D-glucose units. Cellulose is an important s ...

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, 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 (medicine), indication or in an unapproved age group, dose (biochemistry), dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) ca ...

in the USA for adhesion prevention including Evicel, Surgiwrap, CoSeal and Preclude, the latter being a product of Gore-Tex, not being absorbed and requiring a second intervention/operation for removal. Products available for adhesion prevention outside the abdominal and

pelvic The pelvis (: pelves or pelvises) is the lower part of an anatomical 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). ...

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