Informed consent checklists for midurethral slings: a common-sense approach

Area of Science:

• Urogynecology
• Medical-Legal Studies

Background:

• US FDA warnings on transvaginal mesh for pelvic organ prolapse (POP) and single-incision slings for incontinence have increased medical negligence lawsuits.
• Despite warnings, polypropylene midurethral slings and sacrocolpopexies were not questioned by the FDA.
• Patients increasingly require defense regarding midurethral sling use, citing undisclosed complications and lack of discussion on alternative treatments.

Purpose of the Study:

• To address the rise in medicolegal proceedings concerning midurethral slings.
• To propose the use of preoperative checklists as a supplementary tool for informed consent.
• To provide an expert clinical and legal perspective on the controversial use of polypropylene mesh in urogynecological surgery.

Main Methods:

• Review of FDA warnings and their impact on litigation.
• Analysis of common reasons for lawsuits related to midurethral slings.
• Proposal of preoperative checklists to enhance informed consent procedures.

Main Results:

• Litigation has surged, often stemming from "breach of duties" related to informed consent and documentation.
• Preoperative checklists are identified as a potential response to mitigate legal risks.
• The study emphasizes the importance of thorough patient discussion regarding alternative treatments.

Conclusions:

• The use of midurethral slings remains controversial, necessitating careful patient management.
• Preoperative checklists can strengthen the informed consent process for surgical correction of stress urinary incontinence (SUI).
• This clinical opinion advocates for enhanced documentation and patient communication to address legal challenges in urogynecology.