Adhesions – One of the Major Unsolved Problems of Surgery
Ever since the first surgical incision, adhesion formation has remained one of the most common unsolved complications following surgery. Adhesions form immediately after all surgery as a part of the normal healing response to tissue trauma. Adhesions growth initiates within the first 3-5 days after surgery and are made up of sticky fibrous bands of scar tissue. If development of adhesions can be interrupted in these first days, several potential complications of surgery can be avoided.
More than 90% of patients develop peritoneal adhesions following abdominal or pelvic surgery. In most patients this tissue is remodeled and eventually dissolves. However, in millions of patients worldwide sustained adhesions can attach to organs or tissue that are normally separate, such as intestines, bowels, uterus, ovaries and other organs, causing dysfunction and complications. Within the abdominal cavity adhesions can cause bowels and pelvic organs to adhere to each other thus creating risks for small bowel obstruction, female infertility and pain. Adhesions can make future surgery more difficult and limit future treatment options, such as minimally invasive surgery.
Adhesions are the most common cause of small-bowel obstruction and account for 70% of all cases. Tubal adhesions account for up to 40% of female infertility cases and many women develop pelvic pain due to postoperative adhesions.
In a large American database study the annual cost for direct hospital and surgical expenditures has been calculated to $1.3 billion in 1994. A more detailed analysis in Sweden demonstrated a yearly cost of approximately SEK 500 million ($70 million) with direct hospital expenditures that equal the cost of stomach cancer in Sweden.
Postoperative adhesions are not only a problem after abdominal surgery. The increasing indication for repetitive lung surgery further defines the clear need for an effective thoracic anti-adhesion product. Cardiac patients are often limited in repeat or follow-on surgical options as a result of adhesion formation. Orthopaedic patients undergoing joint and tendon surgery will also have postoperative problems in mobility due to postoperative adhesions and scar formation.
A Great Need for an Effective Adhesion Barrier
Today there are a few medical device products on the market that have some anti-adhesion properties using films, gels, membranes or fluids. However, they do not decrease the clinical problem of small bowel obstruction and infertility and have experienced limited adoption in practice in most countries. Most products are difficult to apply and will not work in many circumstances, such as bleeding, infections and anastomotic surgery. Currently there is no pharmacological treatment available to prevent clinical problems following adhesions.
Several current commercial products have had problems showing effect on clinically valuable end-points and are limited by various shortcomings. There is a great need for an effective and easily applied anti-adhesion product for all types of surgery.
Such a product would have a large impact on post-procedural patient management and re-intervention and, as a result, health finance. The anti-adhesion market offers a large, untapped market opportunity. The current estimated world market size for abdominal and pelvic surgery alone exceeds $800 million. Adding new indications such as thoracic and orthopaedic surgery would significantly increase this market.
The ideal product should be:
- Effective in the targeted area for at least 5 days
- Biologically degradable
- Non-interfering with normal healing
- Non-interfering with immunological functions
- Applicable in various settings such as bleeding, infections and anastomotic surgery
- Easy to apply