Vesica Procedure Gives Birth to Pelvic Mesh – Pre 1996

[Trigger warning: This story contains graphic surgical details.]
If you have a retropubic bladder sling, you may want to get familiar with the procedure that paved the way for yours and all pelvic meshes. The Vesica technique was used to implant the ProteGen, the evil grandmother of all transvaginal mesh.

The story below was pieced together from historical patent applications, MAUDE reports, and donated personal stories in order to create a composite patient with the pseudonym Abbey Nordell. On the day of her operation for a little bladder leak, her surgeon, Brian Malikoff (also a pseudonym), asked the young woman who peed when she sneezed to sign a consent for a “Vesica Procedure” before he headed off to “scrub in.”

A short while later, Nordell was flat on the table, covered with a sheet,  ankles in stirrups when Malikoff swept into the operating room.. After saying hello, Malikoff watched his sedated patient drift off to sleep. Pushing his foot on a floor pedal, he tilted the table backward until his patient’s head was lower than her hips. The circulating nurse adjusted a powerful light behind his head until the young doctor could visualize the area of Abbey’s body she normally kept very private.
With a gloved hand, Malikoff unfalteringly inserted a sixteen-millimeter diameter Foley catheter, pushed a tablespoon of water through it and inflated her bladder just enough to feel her urethra through the front wall of her vagina with the other. Next, he took a pair of sharp tipped scissors and cut open a hatch-door-shaped flap at the top front of her vagina. He Exchanged the sharp scissors for blunt-tipped ones and, keeping them closed, swept the tips back and forth through the space outside of her vaginal canal, the periurethral fascia (periurethral fascia includes the obturator fascia, covers the pelvic walls formed primarily by muscles that pass from the interior of the pelvis to the thigh), until he separated her bladder from her vagina.

Illustration from Vesica Patent

The fascia around Nordell’s urethra is part of an uninterrupted head-to-toe system that surrounds and permeates every tissue in her body: organ, bone, muscle, skin, nerve, artery or vein. Fascial structures are made of collagenous tissue which is pre-loaded with tension and can stretch or compress in many directions without losing strength. They act as a lubricant to the surrounding surfaces. Cuts to Nordell’s fascia will heal, but will become scarred, more rigid, and change shape. To Malikoff, this was a reasonable trade-off with an acceptable risk-benefit ratio (a complex decision that balances the degree of illness or injury, the patient’s age and health, especially circulatory health, how well the patient is responding to non-surgical treatments, the patient’s feelings about surgery, and how much risk there is for surgical complications).
On each side of Nordell’s incision, Malikoff separated further using both sharp and blunt tools, cutting sideways as far as possible to avoid injuring her bladder and urethra. He then punctured her endopelvic fascia (Endopelvic fascia includes the obturator fascia, covers the pelvic walls formed primarily by muscles that pass from the interior of the pelvis to the thigh) behind her pubic bone and cut a path wide enough to pass a large darning needle-shaped instrument known as a “Stamey needle.” (Stamey needle: used for pulling sutures from a vaginal incision into the suprapubic area during bladder suspension surgery. This needle is reusable.) He then made a half-inch long incision deep enough to reach the next fascial area rectus fascia (thin but very tough layer that covers the abdominal muscles) above her pubic bone where he would soon anchor a suture. The circulating nurse opened a sterile package containing a Vesica kit and carefully dropped the contents onto the Mayo Stand (metal table that holds surgical instruments): two screws with sutures attached and a tube-shaped drill guide.

Two examples of anchor fixation devices

Still gloved, Malikoff grasped a tube-shaped drill guide and used it to insert a tiny anchor. He located specific internal landmarks at the back of Nordell’s pubic bone with his fingertip and aimed the head of the guide into the bone’s periosteum (dense fibrous membrane covering the surface of bones) and twisted the first tiny screw until it was securely seated. The second screw was not so easy. When he realized he accidentally twisted it into a ligament, his heart stopped. Unable to back it out, he cut the errant suture lose with a tiny saw Boston Scientific provided for this kind of mishap and requested a second Vesica kit to access a third screw. (The misplaced screw remained inside her body for years to come. She discovered it many years later.)*

Pubic bone

Malikoff then pulled the two properly secured sutures around her urethra and up through the incision above her pubis. After placing two fingers through her vagina and between the sutures and her urethra he estimated the amount of tension and then tied the ends above with a square knot “I’ll tie eight knots just to be sure. We don’t want this unraveling,” he said to no one in particular.
To make sure there was no injury to Nordell’s urethra and that the sutures were not to tight, Malikoff passed a cyctoscope (slender, cylindrical camera for examining the interior of the urinary bladder) into her bladder to look for signs of perforation. Happy there were none, he closed her vaginal and suprapubic incisions with absorbable sutures, inserted a Foley catheter and vaginal packing and signaled the anesthesiologist to wake her up.
* * *
Nordell’s procedure never worked to stop her leakage but put her into a world of pain. She began to suffer from UTI’s and the sutures cut her husband making love-making an ordeal.
The F.D.A. provides a place to report disasters like Nordell’s but the vast majority of tragic outcomes never make it there. Doctors are not required to report complications and company representatives rarely follow the reporting mandate. Medical personnel, lawyers, and patients themselves can report negative experiences to M.A.U.D.E. (Manufacturer and User Facility Device Experience), however. That’s how we know that, before pelvic mesh caused a slew of problems, patients were already suffering.
Look for more stories about other mesh inventions as I attempt to cover each different type of pelvic mesh.

* * *

*When the circulating nurse cleaned up after the surgery, she threw away a small folded paper that dropped out of the Vesica Kit package called the “instructions for use” (IFU). Those instructions recommended surgeons prepare for Vesica procedure surgery by planning in advance a way to replace “dropped, contaminated, mal-positioned or non-working screws” and by having extra supplies and extraction tools on hand—as Malikoff had done.

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Peggy Day is working on a book to combine all these stories. This is an excerpt from . Your input is welcome to help make Pelvic Mesh Owner Guide the book you need to read.

If you’d like to join an online support group and learn about erosion, partial removals, surgeons, or just find out that you are not alone, join my group, Surgical Mesh or check the list of support groups here.

Subscribe to PelvicMeshOwnersGuide.com to learn more about pelvic mesh. I’d like to hear from you if you are helped by what you read here or if you need to know more about any particular topic. Comment below or email me privately at daywriter1@gmail.com.

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