03/29/2013 // Concord, CA, USA // LifeCare123 // Greg Vigna, M.D., J.D., Gregory Rueb, J.D. // (press release)

The application of surgical mesh by way of transvaginal approach has been a debacle caused by a dangerously defective product that was ill conceived from the onset, inadequately studied, and overly marketed to the public and physicians. Further is has been determined that the transvaginal mesh provides no greater benefit to the public than the old traditional non-mesh related procedures used for pelvic organ prolapse and stress urinary incontinence.

Unlike other patients who have suffered catastrophic injuries, transvaginal mesh patients generally will not appear disabled. By utilizing demonstrative evidence a skillful attorney will be able to direct the focus of the jury on the key structures of the pelvis that are impacted by the transvaginal mesh rather than the outward appearance of the patient. By focusing the attention on the loss of function, the loss of intimacy caused by mesh related painful intercourse, and intractable pain there will be a maximum award to compensate the pain and suffering caused by this device.

Demonstrative evidence is essential to disassociate the jury’s attention from the outward appearance of the plaintiff to the dangerousness of the device, the greed of the manufacturer, and proximity of the transvaginal mesh to vital key structures of the pelvis. In preparation for trial, focus groups that I have participated in have demonstrated that it is necessary to use 3D animation to adequately describe the function, the structure of the pelvis, and the effects of both the procedure and the device on the female pelvis. Dr. Michael Hibner, an internationally recognized expert in the management of chronic pelvic pain, in an interview with Dr. Greg Vigna, M.D., J.D. stated that no structure other than the brain is so complex, with functions that include sexual, reproductive, and excretory function of the bladder, and evacuation of the rectum and anus. Testimony by an expert that the 3D animations are accurate depictions of the female pelvis, the reproductive organs of the uterus, ovaries, and fallopian tube can help the jury understand the true nature of the injuries. The sexual structures of the clitoris and the vagina can be displayed. By layering one structure on another such as the bladder, the rectum, the anus the viewers can appreciate the complexity of the anatomy. The pelvis also contains muscles, ligaments, and joints that are essential for the function of mobility. These structures should be layered on to the structures mentioned above by 3D animation and testified by the expert to accurately depicting the complex anatomical structures of the pelvis.

Finally, by 3D animation the nerves of the pelvis should be layered into the pelvis showing the course from the spine to the structures they innervated. The obturator nerve and the pudendal nerve should be followed throughout their entire course. The terminal branches of the pudendal nerve which includes the rectal, the perineal, and the clitoral nerve and these should be displayed to the jury from both an anatomic standpoint with emphasis to their proximity to the surgical field and the expert should explain to the jury their essential function. This demonstrative evidence will crystalize just how complex anatomically and functionally the pelvis is to the jury.

Demonstrative evidence is essential for the jury to understand how the transvaginal mesh kits are flawed from the onset. By way of 3D animation the jury will appreciate how this device is surgically placed and how the arms that anchor the device are place high up in the pelvis near critical pelvic structures. Dr. Hibner in his interview discussed how the arms are placed “up into the pelvis, blind”. The word blind will resonate with the jury when taken into the context of the complexity of the anatomy and the essential functions placed at risk.

One of the most critical questions according to Dr. Hibner when he meets a new patient with pelvic pain following the mesh procedure is what type of device does the patient have. These devices are unique in shape and size and impact different structures of the pelvis. By 3D animation the particular transvaginal mesh device can be displayed to the jury and incorporated in the 3D animation of the pelvis. The specific structure at risk by a particular device can be explained which would provide a mechanism for the pain and function that is compromised. If the 3D animation is inconsistent with the type of pain and functional loss that the patient suffers from, then the testimony of the expert must provide a mechanism of pain and functional loss that would account for the complaints. Case by case this is an exercise that must be understood by the plaintiff’s attorney.

Dr. Hibner stated that a properly placed device can cause nerve damage by way of traction on the nerve and that there are anatomical variances in the general population that may make nerves of the pelvis more susceptible to direct injury from the blindly placed arms. Dr. Hibner states that the device causes an inflammatory reaction to the soft tissues and the muscles which causes pain. The proximity of the mesh device to the pelvic floor can be displayed to the jury by way of 3D animation. The transvaginal procedure itself may damage the terminal branches of the pudendal nerve depending on which procedure was performed and the approach the surgeon took. This can be displayed by demonstrative 3D animation and testified to by the expert.

An attorney with 3D animation should have no problem focusing the jury on the ill-conceived surgical procedure that offers no advantages to traditional non-mesh surgical interventions. It will be apparent that the transvaginal approach places the terminal branches at risk of damage, and requires blind placement of arms which endangers key structures required for reproductive, sexual, mobility, excretory, and evacuation function. The jury will focus less on the appearance of the plaintiff and will focus on the testimony of the witnesses regarding the impact on her life.

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