Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study

Inclusion Criteria:

- Adult female at least 18 years of age.

- Willing and able to provide written informed consent.

- Confirmed pelvic organ prolapse (POP) of Stage 2 or higher as determined by POP-Q
prolapse grading requiring surgical intervention in the anterior, posterior or
combined (anterior and posterior) compartment.

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

Exclusion Criteria:

- Concurrent surgical treatment of pelvic organ prolapse using anything other than the
Axis Dermis.[Note: concurrent mid-urethral sling placement for treatment of stress
urinary incontinence is allowed].

- Confirmed Stage 2 or higher prolapse as determined by POP-Q prolapse grading for a
compartment that is not being repaired in the same procedure. (Concurrent POP-Q Stage
1 repair is at the physician's discretion.)

- Previous pelvic organ prolapse repair using biologic, or synthetic grafts. [Note:
previous midurethral sling for treatment of stress urinary incontinence is allowed]

- Pregnant or a desire to become pregnant in the future.

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

- Severe urogenital atrophy.

- Immunosuppression and/or current systemic steroid user.

- Any contraindication to the surgical procedure.