Urogynecology Experts Respond to Recent FDA Warning Regarding Surgical Mesh Used for the Repair of Pelvic Organ Prolapse

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Drs. Moore and Miklos Offer Additional Advice on Complications Associated with the Procedure

Drs. Robert D. Moore and John R. Miklos, of the Atlanta Center for Laparoscopic Urogynecology and leading experts in vaginal surgery, offer advice regarding the recent U.S. Food and Drug Administration's warning about the complications associated with the vaginal placement of surgical mesh in the repair of pelvic organ prolapse.

Pelvic organ prolapse, or POP, occurs when a pelvic organ (such as the bladder or uterus) drops from its natural position and pushes or bulges into or outside of the vagina. Prolapse can occur after childbirth or surgery if the connective tissues or muscles holding the pelvic organs in place are weakened or damaged. Symptoms of POP include pressure, pain or other bladder, bowel or sexual problems. Prolapse can be repaired either vaginally or abdominally and sometimes with the use of a synthetic mesh graft to help increase cure rates. More recently, "kits" have been designed to help standardize and simplify the placement of mesh vaginally to treat POP. As more of these "kits" have been used in surgical treatments of prolapse, the rate of complications reported to the FDA have also increased.

The FDA's warning states that in the last three years, nine surgical mesh manufacturers have collectively reported over 1,000 complications associated with their products used in POP repair. The most commonly reported complications included vaginal wall extrusion of the mesh, infection, pain, urinary problems and POP recurrence. In some cases, complications related to the surgery resulted in a weakening of the patient's overall quality of life.

Drs. Moore and Miklos state that mesh use has been shown to be beneficial in certain patients when used by experienced surgeons and suggest that it is possible that many of the complications reported could have been avoided had certain factors about both the patient's circumstances and the type of mesh used been taken into consideration. They urge surgeons to study their patient's history carefully, and make an informed decision regarding the particular surgical mesh they use in the procedures and how it is placed. They also stress that surgeons need to review the risks of mesh use with their patients prior to the procedure.

"It's true that many unforeseen complications can arise with any vagina surgery; however, it is far less likely to happen under the care of a specialist. Complications are easier to avoid if the doctor is trained and prepared to handle a specific condition," said Dr. Moore. "As leading laparoscopic prolapse repair surgeons, we have years of experience with POP surgeries and encounter very few complications including when mesh is used in the repair. We are experts in all matters related to pelvic organ prolapse, including the difference in mesh products and which patients may benefit from its use. However, when complications do occur, they are much more easily handled when recognized early and treated by a specialist familiar with these surgical procedures."

Dr. Moore continues, "I agree with the FDA's conclusion that there are many aspects of each individual case that must be fully explored when performing this surgery. Each patient has unique circumstances that affect the surgeon's decision about how the operation should be performed and which patient may benefit from the use of mesh placed. They must be fully understood."

Dr. Moore asserts that the characteristics of the mesh used in POP repair surgery are critical to the success of the procedure. "The mesh kits from different manufacturers may be similar, but they are not all identical. There are variations in the chemical make-up of the mesh material that can lead to some of the complications. In our practice, whether placed laparoscopically or vaginally, we have utilized the type of mesh that has been studied to be the best tolerated with the fewest complications and with which we have yielded consistent success."

Drs. Moore and Miklos urge those suffering from POP to research their surgeon's credentials and choice of surgical method. Given the complications that can arise with such a delicate surgery, patients should seek treatment from an experienced and skillful expert in the field.

About Drs. John R. Miklos and Robert D. Moore:
Drs. Miklos and Moore are internationally recognized experts in laparoscopic, urogynecologic and reconstructive cosmetic vaginal surgery and are pioneers in minimally invasive vagina and bladder surgery techniques. They have been in practice together for over eight years and have published multiple papers on mesh use in pelvic surgery. Their practice, Atlanta Center for Laparoscopic Urogynecology, in business since 1997, is located in Alpharetta, Ga. They are both fellowship trained Urogynecologists and Pelvic Reconstructive Surgeons, Board certified by the American College of Obstetrics and Gynecology and fellows of the International Urogynecology Association and the American College of Surgeons. Individual biographies for Drs. Miklos and Moore and information about their practice and published papers can be found at http://www.miklosandmoore.com.

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