A.M.I. Advanced Pelvic Floor Repair System
Declaration of Pecuniary Interest: The A.M.I. Advanced Pelvic Floor System available in Europe and many other parts of the world has been developed by Dr Bruce Farnsworth at the Centre for Pelvic Reconstructive Surgery at Sydney Adventist Hospital based on his personal experience with implantation of over 1500 patients with prostheses in pelvic surgery since 1996.
Personal History of Mesh Use
Dr Farnsworth first used mesh slings for the treatment of prolapse in 1996 when he commenced the Posterior IVS procedure. Following visits to Italy, Germany and France in 2001 he became convinced that use of a mesh prosthesis was the only real option for succesfull fascial reconstruction in patients who had recurrent prolapse following failed surgery. It was clear that without using some type of reinforcing material there were some patients who would not be able to be cured. Traditionally this group of patients had been treated with a mesh but the mesh had been implanted through an abdominal incision.
First Generation vaginal mesh techniques involved placement of a polypropylene mesh in the vaginal wall to recreate the fascial layers between the vagina and bladder or between the vagina and rectum. The mesh used at these times was either a Surgipro mesh (Tyco) or Vipro II (Ethicon).
Initially, mesh was only used in patients with recurrent prolapse. All patients who chose mesh implantation were well aware that serious complications were possible. The success rate of the procedure was high and fortunately most of the complications that were seen in the early phase of mesh surgery proved to be minor. Patients reported minor mesh extrusions and erosions in 15-20% of cases. A small number of patients also suffered more serious reactions to the mesh but only one patient in several years has had a full blown "rejection" of mesh with complete extrusion of the prosthesis. Most complications and healing issues related to postoperative problems such as haematoma formation and constipation.
All patients treated by Dr Farnsworth who undergo vaginal prolapse surgery with mesh implantation are aware of the risks of pelvic dysfunction, mesh complications, scar tissue formation and dyspareunia that may result. Despite these known risks many patients chose to undertake vaginal mesh implantation because of the better chance of a long term durable result and the knowledge that the chance of serious long term complications was very low.
Subsequent developments in surgical technique and the availability of improved mesh prostheses have led to a steady decrease in the risk of complications.
In the second phase of mesh use 2003-2007 the main prostheses used at Sydney Adventist Hospital were Apogee/Perigee (American Medical Systems) and Prolift (Ethicon) devices. These meshes involved the placement of transobturator slings to provide lateral support of the mesh with fixation to the obturator or levator muscles. A further improvement in outcomes was evident and by 2007 the risk of a mesh related complication was less than 5%.
Since 2001 Dr Farnsworth has conducted an audit of all his operations in order to identify any factors that might be helpful in further reducing the risk of complications and to document surgical outcomes. All patients complete a series of quality of life assessments before and after surgery. After spending a number of years customising his own design from basic mesh prostheses and modifying other mesh kit products Dr Farnsworth sought a manufacturer to produce a customised mesh for his own use. In 2005 Agency for Medical Innovation (Feldkirch, Austria) agreed to manufacture the new APFR system and the product was available for a limited clinical release in late 2007.
APFR System
The Advanced Pelvic Floor Repair System (APFR) has been designed to repair any combination of focal defects in vaginal support. A customised combination of prostheses is available for use by the surgeon in each patient so as to allow accurate restoration of the original anatomy. No tissue or epithelium is removed in this surgery. Hysterectomy is only performed in the presence of coexisting uterine pathology.
The APFR is made up of a number of components which include the CR Mesh, E Mesh, Multi-purpose Sling (MPS) and TVA-TOA Adjustable Sling. This versatility enables a number of various combinations of defects to be treated surgically. The most important component of the new system is the CR Mesh, so named because of the ability to treat either a cystocoele or a rectocoele.
CR Mesh
CR Mesh has been designed to restore fascial support to either the anterior or posterior vaginal compartment. It has a number of features which have been designed to make it less likely to cause mesh related complications after surgery.
Click here for more information about CR Mesh
CR Mesh is now available in Europe and Australia for advanced pelvic floor surgeons who complete a training program. The technique is more complex and difficult than standard techniques using already available mesh but results in a superior result due to the accurate recreation of the pelvic anatomy.
CR Mesh received approval in the European Community when the CE Mark was obtained in November 2007. The CR Mesh achieved TGA Approval in Australia in August 2008.
Dr Farnsworth performed over 200 mesh reconstructions using the A.M.I. Advanced Pelvic Floor Reconstruction System between February 2008 and January 2009. Eighty five of these patients have been operated in Sydney between August 2008 and January 2009. As of February 1st 2009 there had not been any mesh related surgical complications reported in this group of patients.