Results of Xenform® Matrix Repair in Treatment
of Pelvic Organ Prolapse- A Four Year Study
Amita Singla*, Sujana Molaktalla and Priti Pradhan
Consultant, Obstetrics and Gynaecology, The Queen Elizabeth Hospital and Calvary Hospital, Adelaide
Submission: February 18, 2019; Published: May 03, 2019
*Corresponding author: Dr. Amita Singla. Department of Gynaecology The Queen Elizabeth Hospital 28, Woodville Road, Woodville SA 5011, Australia
How to cite this article: Amita Singla, Sujana Molaktalla, Priti Pradhan. Results of Xenform® Matrix Repair in Treatment
of Pelvic Organ Prolapse- A Four Year Study. Glob J Reprod Med. 2019; 6(5): 555696. DOI:10.19080/GJORM.2019.06.555696.
Abbrevations: WHI: Women’s Health Initiative; POP: Pelvic Organ Prolapse; FDA: Food and Drug Administration; PDS: Polydiaxanone Sutures; TEDS: Thrombo-Embolic Deterrent Stockings; IUGA/ICS: International Urogynaecological Association/International Continence Society
Pelvic organ prolapse is a common gynaecological disorder with a 11 % life time risk of requiring at least one surgery to correct prolapse. Approximately, one third of these women face the risk of needing surgery for recurrent prolapse . The Women’s Health Initiative (WHI) study demonstrated post hysterectomy prevalence of cystocoele of 32.9% and rectocele of 18.3% . Similar rates were shown to be prevalent in women with uterus and rate of uterine prolapse was 14.2% . There has been an ongoing clinical need for various materials to reinforce the native tissues to optimise the prolapse repair with particular emphasis to reduce the recurrence [3-30].
i. Anterior compartment prolapse–Hernia of anterior vaginal wall often associated with descent of the bladder (cystocele)
ii. Posterior compartment prolapse–Hernia of the posterior vaginal segment often associated with descent of the rectum (rectocele)
iii. Enterocele – Hernia of the intestines to or through the vaginal wall.
iv. Apical compartment prolapse (uterine prolapse, vaginal vault prolapse) – Descent of the apex of the vagina into the lower vagina, to the hymen, or beyond the vaginal introitus. The apex can be either the uterus and cervix, cervix alone, or vaginal vault, depending upon whether the woman has undergone hysterectomy. Apical prolapse is often associated with enterocele.
v. Uterine procidentia -Hernia of all three compartments through the vaginal introitus.
The terms anterior vaginal wall prolapse and posterior vaginal wall prolapse are preferred to cystocele and rectocele because vaginal topography does not reliably predict the location of the associated viscera in Pelvic organ prolapse (POP) [3,4].
Over the last decade, there has been an exponential increase in use of synthetic mesh for pelvic organ prolapse repair in all the three anatomic compartments. According to industry estimates from manufacturer data in United States, mesh was used approximately in one out of three pelvic organ prolapse (POP) surgeries, and three out of four of the mesh POP procedures were performed by trans-vaginal route [5,16,18,24-30]. Due to large number of complications secondary to mesh use in transvaginal repair like infection, pelvic pain and mesh erosion, The Food and drug administration (FDA) has re-classified the devices from Class II (moderate risk) to Class III (high risk) [6,13,14,17,20,25]. The FDA update in 2011 stated that mesh related complications were no longer considered rare . It has given specific recommendations to clinicians for careful selection of patients for the use of mesh in prolapse repair as well as strong emphasis on counselling.
Various biological grafts have been used to avoid synthetic mesh related complications like infection, vaginal erosions or fistulas [7,8,10,11]. Xenform® Matrix is an acellular collagen based graft derived from foetal bovine dermis. A growing number of reconstructive surgeons advocate for biologic grafts  in which the host tissue repopulates the graft with blood vessels, fibroblast infiltration, and subsequent collagen deposition, creating a new tissue layer that lasts after the graft resorbs. There are three potential outcomes of a biologic graft after surgical implantation: absorption, encapsulation and remodeling. The first potential outcome is simple absorption of the material. This may occur if the host tissue does not recognize the graft as remodelable and simply forms scar tissue in response to insertion of the graft. This response is similar to what might happen if an absorbable
synthetic mesh material, such as polyglycolic acid was implanted.
A potential response to a biologic material, especially one that has
been cross-linked with some chemical, such as glutaraldehyde, is
encapsulation. The body will attempt to wall off the material by
forming a fibrous capsule around the material. The most desirable
outcome, however, is remodeling, whereby the host tissue sees
the graft as a material in which it may re-populate with blood
vessels, blood cells, collagen, and growth factors. The anticipated
result is that after the biologic graft reabsorbs, the patient is left
with a stronger layer of “fascia” beneath the vaginal epithelium
[7,10,15,21,23]. Due to its origin from foetal dermis, it has higher
type III collagen content than type I collagen. Type III collagen has
less inflammatory cells with higher metalloproteinase to tissue
derived inhibitor ratio that favours remodeling over collagen
Non crossed linked intact porcine- derived acellular dermal
matrix is designed to perform as surgical matrix for soft tissue
repair while serving as a scaffold for the rapid ingrowth of host
cells, collagen and blood vessels . The length of remodelling is
variable and based on patient characteristics. In a rat model, by
12 weeks, there was no inflammatory response and population by
host fibroblasts was noted which is typical of wound healing .
The aim of this study is to determine the success and complication
rates of Xenform® matrix in the treatment of pelvic organ prolapse
over a three year period from 2011-2014 
This is a retrospective study which included fifty seven
(57) women who underwent pelvic organ prolapse repair with
Xenform augmentation by single operator. The ethics committee
at The Queen Elizabeth Hospital, Lyell McEwin Hospital and
Modbury Hospital approved this retrospective audit. The ethics
review reference number was Q20151101.
Women with Grade II or greater pelvic organ prolapse (as per
POP Q classification) were treated with Xenform during primary
surgery or during secondary surgery for recurrent prolapse.
Xenform was placed either in anterior or posterior compartments
as a single procedure, with traditional native tissue repair or for
either compartment if clinically indicated. The POP Q scoring
system was used to assess the degree of prolapse to maintain
consistency in the pre- operative and post- operative findings.
Demographic criteria included age, parity, previous conservative
management such as Neo-Tonus chair (Extracorporeal Magnetic
Innervation), vaginal oestrogen cream and pelvic floor exercises
as well as previous native and mesh repair surgeries (Table 1).
Concomitant surgeries such as sub urethral sling procedures
were performed according to the clinical indication and associated
urinary stress incontinence after outpatient urodynamic studies.
Patients were followed up at 6 weeks, 3 months, 6 months
and 12 months after the procedure. At each post-operative visit,
review of clinical symptoms and assessment of grade of prolapse
as per the POP Q classification was undertaken. Objective success
was defined as no or Grade 1 prolapse at 12 months of follow up
and subjective success was defined as no prolapse symptoms or
no bulge reported by patients at 12 months. Surgical failure was
described in terms of subjective and objective assessments (Table
2). Graft failure was determined at 6 weeks with recurrence of
The intra-operative complications were recorded as followingureteric
injury, bladder injury, vaginal mucosal injury (button hole
tear), urethral injury, bowel injury, vascular injury, neurological
injury, perioperative blood transfusion and blood loss > 500ml.
Peri-operative complications such as unplanned return to
theatre for procedure related event within 72 hours, prolonged
catheterization for more than 10 days post operatively and return
to hospital within 30 days, with procedure related event were
Post-operative complications include de novo dyspareunia,
recurrence of prolapse at the same site requiring conservative
treatment, recurrence at same site requiring surgery, recurrent or
new incontinence requiring surgery, vaginal narrowing secondary
to mesh retraction. Complications were classified and documented
according to the International Urogynaecological Association/
International Continence Society (IUGA/ICS) . The case notes
were reviewed for data collection. This retrospective audit was
approved by Hospital Ethics Commit.
Of the 56 women included in the study,, 12 % had prior repair
done. 18 % had had undergone prior hysterectomy and at least one
compartment prolapse. 45 % of the patients had been treated with
neo-tonus chair and one third had been commenced on pelvic floor
exercises and hence, failed non-surgical management of prolapse
(Table 1). Out of the 56 women included in study, approximately
12 month follow up data was available for 47 patients due to loss
of 9 patients for follow up in clinic especially in public hospital.
Anterior compartment prolapse was the most common condition
requiring surgery and success rate was 75% at 12 months after
surgery, with 25 % failure rate thus having a subjective cure rate
of 75% (Table 2 &3, Figure 1). Other concomitant procedures
done were anterior repair (4%), Posterior repair (43%), Vaginal
hysterectomy (12.5%) and mid urethral sling (32%) (Table 4).
In our series, there were no vaginal erosions, contractures
and need to revise the mesh during the follow up. One case
with secondary hemorrhage needed return to theatre and need
for re-suturing of vaginal wall (Table-3). There was one case
of symptomatic granulation tissue and vaginitis that required
conservative management with oral anti-biotics. One patient had
de novo dyspareunia that was reported at 6 months follow up
and was not associated with any vaginal erosion and stenosis or
recurrent prolapse (Table 3). Out of the 12 patients of recurrence
group with same site prolapse, 3 required interventions with
native tissue repair and one patient underwent second Xenform
implantation in same compartment. Out of the recurrence group,
2 had different site prolapse (posterior compartment and uterine
prolapse), and one patient underwent native tissue posterior
Our retrospective study was aimed to determine the success
rates and complications associated with Xenform matrix use for
reinforcement in trans-vaginal prolapse repair. Our study shows
very promising results with the success rate of 75 % and no major
complications or other unique problems associated with the use of
synthetic mesh . Thus, this audit demonstrates that Xenform
matrix use in prolapse repair shows promising results.
There were fewer minor complications like urinary retention,
vaginitis. The case of de novo dyspareunia wasn’t associated
with vaginal erosion or contracture. Even though our study
demonstrated failure of repair in 12 cases, only 4 cases of same
site recurrence required second procedure.
Only other prospective cohort study by Goldstein et al
reported 88% success rate based on mean Ba and Bp points at
one year follow up. This group of 43 demonstrated no erosions
and significant improvement in PDFI-20(pelvic floor distress
inventory score) [8,22]. Xenform Soft tissue repair matrix is
derived from fetal dermal bovine tissues [7-12] that, per World
Health Organisation and European designation, has no known
detectable prion infectivity. It is solely derived from cattle obtained
in compliance with US and European regulatory requirements.
Xenform Matrix is intended for use as a soft tissue patch and
is indicated for  repair of colon, rectal, urethral, and vaginal
prolapse; reconstruction of the pelvic floor for procedures such as
sacrocolpo suspension and urethral sling. This is a retrospective
study of a small group of patients (N=56), with initial follow up
for a period of 12 months. The study includes all patients operated
by a single practitioner with consistent surgical procedure; the
general application to other practitioners would involve learning
curve and requires appropriate training. The lack of longerterm
follow up could potentially miss late failures due to myxoid
degeneration of the graft.
Nevertheless, our study is the largest retrospective study
available regarding the Xenform use in pelvic organ prolapse
repair as prior studies were in relation to use in dura-mater repair
and urological procedures . Hence, the emphasis should be on
long term follow up with standardized questionnaires to assess
quality of life and sexual function after prolapse repair.
Aguirre OA (2002) Foetal Bovine Dermal Graft (Xenform Matrix) in Pelvic Floor Reconstruction The Centre for Female Pelvic Medicine, Englewood, Colorado, USA.
Vivian W Sung, Rebecca G Rogers, Joseph I Schaffer, Ethan M Balk, Katrin Uhlig, et al. (2008) For the Society of Gynecologic Surgeons Systematic Review Group, Graft Use in Transvaginal Pelvic Organ Prolapse Repair A Systematic Review 2008 by The American College of Obstetricians and Gynecologists.
Bernard T Haylen, Robert M Freeman, Steven E Swift, Michel Cosson, G Willy Davila, et al. (2011) An International Urogynaecological Association (IUGA)/International Continence Society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) & grafts in female pelvic floor surgery, Int Urogynecol J 22: 3-15.
Sara Armitage, Elvis I Seman, Marc JNC Keirse (2012) Clinical Study Use of Surgisis for Treatment of Anterior and Posterior Vaginal Prolapse, Department of Obstetrics, Gynaecology and Reproductive Medicine, Flinders Medical Centre and Flinders University, Adelaide, SA 5042, Obstetrics and Gynecology International Volume.
Peter Rosenblatt, Emily Von Bargen (2017) Use of biologic grafts in pelvic organ prolapse surgery, Contemporary OB/ GYN.
Silva WA, Karram MM (2005) Use of biologic grafts in pelvic organ prolapse surgery, Scientific basis for use of grafts during vaginal reconstructive procedures. Curr Opin Obstet Gynecol 17: 519-529.