Lessons from the past: directions for the future

Abstract

New procedures and materials for incontinence and prolapse are proliferating rapidly. Surgical procedures were developed by physicians and carried their names, but over the last 15 years, these procedures are developed by industry and bear the trade names of the companies selling the kits needed to perform them. The Food and Drug Administration (FDA) approves devices, not procedures, and does not require submission of efficacy or adverse-event data to gain this approval by the 510-K process. Evidence-based medicine is lacking in the performance of these procedures that may be considered experimental by an insurance company or malpractice carrier with denial of payment or coverage. Physicians and hospitals are exposing themselves to financial, legal, and ethical risks when performing or allowing such procedures to be performed. Informed consent from the patient cannot be obtained. We must not confuse medical marketing with evidence-based medicine.

Surgical management of stress urinary incontinence in women: safety, effectiveness and cost-utility of trans-obturator tape (TOT) versus tension-free vaginal tape (TVT) five years after a randomized surgical trial

“…There has been increasing concern about the introduction of new surgical devices into urogynaecology without evidence of safety and effectiveness[7-9]. Device manufacturers are not required to provide such information to obtain a license in Canada, the USA or Europe, if a device is made by a manufacturer who makes similar products or if a similar product is already produced by another manufacturer [10-12].…”

“…Device manufacturers are not required to provide such information to obtain a license in Canada, the USA or Europe, if a device is made by a manufacturer who makes similar products or if a similar product is already produced by another manufacturer [10-12]. Therefore it becomes the responsibility of clinicians to evaluate any known relevant evidence [7-9,13]. Unfortunately even if short-term outcome is known, longer term outcomes usually remain unknown, and therefore clinicians are unable to fully inform patients of the consequences of surgery.…”

Biomaterials in the treatment of pelvic organ prolapse and stress urinary incontinence: An update

“…Perhaps blind passage of the trocars through the levator musculature, ischiorectal fossa, and sacrospinous ligament poses a risk for these complications. These concerns have prompted comments regarding new procedures and materials for the treatment of incontinence and prolapse, warning that insuffi cient data support their routine use [ 50 ]. Therefore, physicians must relate to patients that these procedures have uncertain long-term results and involve unique risks of organ and vascular injury.…”

Ethical Principles for Introducing Device and/or Mesh Use Into Your Practice

“…Given the multitude of unknowns regarding the safety and efficacy of various mesh devices, the possibility of truly valid informed consent for the use of these materials in pelvic floor repair has been questioned. 7 However, given the potential benefits of mesh to many patients and the increase in available data, this seems a bit cynical. Broadly, informed consent is considered to consist of 3 key elements: information disclosure, patient understanding, and a voluntary decision.…”