Use of grafts in pelvic organ PROLAPSE

 

 Graft materials for POP(Pelvic organ prolapse) Grafts have been employed in repairing defects or hernias throughout the body. Their purpose is to either completely replace the weak tissue by spanning across that tissue or to provide a scaffold for fibroblast infiltration. The patient’s own connective tissue may grow into the graft, and if the graft is degradable, replace the graft as a supportive structure. Graft materials include autologous tissues like cadaveric allografts and fascia, dermis and other connective tissues, xenografts from animal sources, and various synthetic materials.

 

Julian first reported on the use of synthetic mesh for cystocele repair in 1996.Recently a number of prolapse repair mesh devices have been designed by different companies and extensively marketed as a minimally invasive approach for pelvic floor repair. Each of these prolapse repair mesh devices utilizes woven monofilament low-weight macroporous polypropylene meshes with extension arms to permanently reinforce the pubocervical and the rectovaginal fascia. Insertion techniques are very similar and involve the use of especially shaped insertion needles to anchor the mesh arms. The needle passage lies close to vessels, nerves and organs of the pelvis and pelvic sidewall, with slight differences between devices as to which structures are closest to the needle tracks.

Perigee and Apogee are comprehensive, single-use needle suspension kits that provide a standardized delivery method for mesh or graft-augmented repairs.

Perigee uses the transobturator technique for the treatment of anterior prolapse;

 

Apogee uses a posterior vaginal and perianal approach for the treatment of vault and posterior prolapse. These kits represent the “next generation” in vaginal prolapse repair because they allow for safe, consistent, comprehensive treatment and offer tension-free mesh or graft augmentation options to accommodate individual patient pathologies. They allow pelvic organ prolapse to be repaired in a minimally invasive manner with a short procedure time and the postoperative recovery is also rapid.

Inclusion criteria for Perigee or Apogee are patients with symptomatic anterior or posterior vaginal wall prolapse respectively with stage 3 or more as per the POPQ systems.

Exclusion criteria for Apogee and Perigee are patients with pelvic organ prolapse less than stage II (POPQ) or patients with history of prior graft- augmented repair and patients with systemic or local conditions that would preclude surgery or affect healing such as coagulation disorders, infections, compromised immune response, vaginal bleeding, uncontrolled diabetes, restricted leg motion (inability to conform to the lithotomy position), history of pelvic cancer in previous six months, history of radiation to the pelvic area.

APOGEE SYSTEM -

 

o The Apogee kit includes 2 thin-profile, curved needles and 1 precut, large-pore polypropylene mesh graft, approximately 5 cm by 13 cm, with 2 mesh arms.

o The kit can also be used with a lyophilized porcine dermis graft.

o The Apogee kit enables surgeons to repair multiple defects with one ready-to-use, preconfigured system.

o Held in the 12 o’clock position, the needle should be inserted into the incision and passed through the ischiorectal fossa.

o Has a 2 point approach

 

advantages of the APOGEE procedure —

o Minimally Invasive

o No abdominal incisions (vs. Sacral Colpopexy) o Decreased risk of bleeding (vs. Sacro-Spinous ligament fixation SSLF) o Decreased risk of nerve injury (vs. SSLF) o No general anaesthesia required (vs. Sacral colpopexy)

o Decreased recovery period, o Treats rectocele, enterocele and vault prolapse in one procedure

PERIGEE -

As compared to Apogee, Perigee has a 4 point approach. Principle of PIVS remains the same and is indicated for anterior wall defects.

 

o New minimally invasive vaginal approach for Vault Prolapse, o Transobturator Approach

o For repair of anterior vaginal wall defects (all central, lateral, proximal and distal defects) o Provides Level 2 support o Four point fixation

COMPLICATIONS OF THE APOGEE AND PERIGEE SYSTEMS (58,59)

Mesh exposure / vaginal erosions — 0 — 25%

Dyspareunia — 2% - 69 %

Urinary symptoms — 3% - 23%

Constipation and Voiding difficulties — 4.3% - 24%

Post operative infection — 2.3% - 31.5%

In 2008, FDA issued a warning regarding the use of mesh for prolapse and incontinence repair , the warning being repeated in 2011, although narrowing it to vaginal mesh used to correct pelvic organ prolapse (not for anti-incontinence procedures or when used abdominally). These warnings arose from concerns over mesh erosion through vagina, pain, infection, bleeding, dyspareunia, organ perforation and urinary problems. While many of these complications are common to all pelvic floor repairs, mesh erosion and some type of organ perforation are surely unique to mesh and trocars used for its placements.