Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study

Inclusion Criteria:

- Adult female at least 18 years of age

- Willing and able to provide written informed consent

- Diagnosed with clinically significant pelvic organ prolapse of Stage 2 or higher as
determined by Pelvic Organ Prolapse Quantification System (POP-Q) requiring surgical
intervention in the anterior and/or posterior compartment

- Willing and able to complete all follow-up visits and procedures indicated in the
protocol

Exclusion Criteria:

- Concurrent surgical treatment of pelvic organ prolapse using anything other than the
Restorelle Direct Fix A&P

- Confirmed Stage 2 or higher prolapse as determined by POP-Q for a compartment that is
not being repaired in the same procedure

- Previous pelvic organ prolapse repair using synthetic grafts

- Patients requiring a total hysterectomy (i.e. removal of the cervix) at the time of
vaginal reconstruction

- Patients requiring a procedure for fecal incontinence (i.e.) anal sphincteroplasty)
at the time of vaginal reconstruction

- Pregnant or a desire to become pregnant

- Previous radiation or other treatments for cancer in the pelvic area

- Immunosuppression and/or current systemic steroid user

- On any anticoagulation therapy at the time of implant or with bleeding diathesis