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European Market Report for Pelvic Organ Prolapse Devices 2016 - MedCore

European Market Report for Pelvic Organ Prolapse Devices 2016 - MedCore

  • September 2016
  • 82 pages
  • ID: 4785424
  • Format: PDF
  • By iData Research, Inc.


Table of Contents

The market is expected to continue a substantial shift from transvaginal mesh to sacrocolpopexy mesh. While transvaginal mesh sales currently comprise the majority of the market, their dominance will decrease as physicians move towards sacrocolpopexy mesh at increasing rates. Although the U.S. market was struck heavily by the FDA warnings issued in 2011, the European market was never substantially impacted. The United Kingdom has been by far the most impacted, possibly because of the high degree of cross-over in negative press between the two countries regarding pelvic organ prolapse procedures using mesh.

Modifications to the mesh, extra clinical trials to prove safety and pre-emptive marketing is helping to clarify the safety and health risks associated with mesh to curb the decline in procedures. ASPs for both types of mesh have been relatively stable, with a slight decline on average over the past few years. In Europe, there are many smaller companies that compete in the incontinence sling market. Competitive pricing, which pushes down ASP, is one of the tactics that allows these smaller companies to thrive amongst larger medical device corporations. Changes in the market due to companies choosing to leave the market, notably Johnson & Johnson’s transvaginal mesh products, has allowed many smaller competitors to better position themselves in their respective markets.

In the pelvis, the pelvic floor holds the vagina, bladder and uterus in place. The pelvic floor is made of ligaments that stretch across the inside of the pelvis. In a normal situation, the uterus, bladder and the upper part of the urethra lie above the pelvic floor. The vagina, rectum and the lower part of the urethra all pass through the pelvic floor to the outside. The vagina passes through the center of the pelvic floor, with the urethra to the front of it and the rectum behind.

Situations like childbirth, chronic cough, obesity or hormonal changes can cause the organs held in place by the pelvic floor to drop; this condition is also known as prolapse. Different types of prolapse exist: cystocele, a prolapse of the bladder into the front wall of the vagina; hysterocele, a prolapse of the uterus into the back, front or top of the vagina; rectocele, a prolapse of the rectum into the back wall of the vagina; urethrocele, a prolapse of the urethra into the lower front wall of the vagina; and enterocele, a prolapse that contains loops of bowel.


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