The FDA, Vaginal Prolapse Repairs and Implications
By Marja Sprock, M.D.

On July 13th, the FDA issued an updated warning against the use of vaginally implanted meshes. This was based on the perceived high number of reported complications for this biomedical device used to treat severe and often recurrent vaginal prolapse. The repair without the use of an artificial material, be it polypropylene or derived from animal sources, does not get reported, since it does not involve FDA regulated material.

The pelvic prolapse surgeon network has drafted a letter to the FDA that I cosigned, to put some of the accusations against mesh material used in the vagina in perspective.

The goal of the letter, which has already received over 400 pelvic floor surgeon signatures is to express our opinions and concerns to the FDA, since the July update fails to convey an accurate reflection of the vaginally placed mesh for prolapse repair and is not consistent with the current literature and experience. In broader perspective; every prolapse option involves risks and benefits.

In actuality, a lot of people, including other physicians start laughing when I tell them: "I fix vaginas"; reality is, it is an art and you need to know what you are doing. A lot of weight is put on a vagina, it has to withstand a lot of forces, and we do not like it too wide or too small, not too deep and not too superficial and keep on going. Once your entire vagina or parts of it start hanging down and put pressure on your back or make it difficult to empty your bladder or rectum, or you are up the whole night going to the bathroom, you'd like some relief. Pessaries, small shelves to hold up a bladder or small bowel are great for some people, however they create discharge, are less than romantic to take out right before intercourse and sometimes do not even hold the large prolapsed vagina anymore.

Vaginal repair of prolapse without a mesh is definitely an option, however for the descent of vaginal tissue to the opening of the vagina or through the opening, not very realistic. Support is severely defective and the past has shown us, a lot of these "native tissue repairs", or in other words use your existent defective tissue repairs, do not work, last or make sex impossible or painful or cause pelvic pain. The same problems you could get with mesh repairs. Again vaginal prolapse repair is an art, it is for the specialist.

Laparoscopic, robotic or abdominal sacrocolpopexy is our "gold standard"  for vaginal prolapse repair. It uses the same mesh material; however the mesh is introduced through the abdomen and not the vagina. Research shows this approach has the lowest failure rate, however there are also mesh erosion problems (mesh showing itself without vaginal tissue covering) and the bowel could get stuck to the mesh, often requiring another invasive surgery. Also for a lot of women this approach is not an option, since the surgery is more involved and takes longer. If you are a healthy 55 year old with your bladder protruding through your vagina, it is probably a great surgery for you, but not if you are the same age, have severe diabetes mellitus and had a quadruple bypass. However you may still not desire a pessary, but want your vagina surgically fixed.  A vaginally placed mesh may be the best option for you,-let us not prevent this from happening. Another option, the only prolapse surgery that I refuse to do, is to close off the vagina. The published rate of complications for the colpocleisis, is close to 33% and I refuse to take away/close a vagina, if I can fix the problem in the same amount of time with a mesh and much lower rate of complications.

The vaginal prolapse surgeon consortium is fighting for women with the data from the literature to support us, that there is a place for the vaginally inserted mesh. Other repairs of the severely descended vagina all come with their potential problems also, there is no free lunch.

Women need their options, severely prolapsed vaginas interfere with quality of life, do not take away a good option to repair a vagina for the right woman in the right surgeons hands. A high rate of satisfaction is noted for patients undergoing vaginally placed mesh repairs, in the hands of well-trained pelvic floor surgeons, as quoted from the evidence based response from Pelvic Surgeons to the FDA Safety Communication.

Yesterday I saw Ruth, a 78 year old active lady in the clinic, 6 months after vaginal insertion of a mesh to fix her bladder and top of vagina prolapse through her vaginal opening. Ruth is doing great and has a normal well-functioning and supported vagina. When asked if she read some of the articles that had come out regarding the FDA mesh warning, she said sure, "means little to me. You told me it was no 100% guarantee and told me about possible problems and I accepted that. To interview some people with problems, means little to me, it is sad, but will happen with any surgery, I am great now."

My next patient Mary, another 78 year old, used to have her vagina hanging out for 1.5 inches and came for her 2 year checkup. Mary wrote me a little testimonial: "This surgery has improved my quality of life and all my check-ups have been excellent. This prolapse caused a lot of stress on me and my recovery was quick and easy. Thanks, Mary R”.

Not every vaginal prolapse needs repair, not every prolapse repair needs mesh and not every mesh repair can be done laparoscopically or robotically. The experienced vaginal surgeons are speaking up for women to keep the option of repairing a severely prolapsed vagina with vaginally placed mesh open. There are possible complications with any surgery, any surgeon claiming there are none, has either not done enough of them, is never in the operating room or is untruthful.

Severely prolapsed vaginas are debilitating and interfere with the quality of life of many women, a vaginally placed mesh in the right surgeon's hands  could be the best choice for some of us, let us not give up this option. Remember there is no free lunch; any surgery has its risks and benefits.

Please call for an appointment at 321-806-3929, send us a note or visit us online at www.CFUroGyn.com.