Penile prostheses and the litigious patient: a legal database review.

Introduction: Erectile dysfunction (ED) is a common problem with significant impact on patient quality of life. Penile prosthesis implantation provides an effective treatment for ED but as an invasive procedure carries with it an increased risk of medicolegal liability.

Aim: To investigate factors associated with malpractice litigation surrounding penile prosthesis implantation.

Methods: The Westlaw legal database was used to perform an advanced search for case reports using the term "medical malpractice" in combination with "penile" or "penis" and "prosthesis" or "implant" with dates between the January 1990 and December 2013.

Main Outcome Measures: Each report was examined for trial information including patient demographics, device model and indications, alleged breach of duty, alleged damages, progression to trial, case outcome, and plaintiff award(s).

Results: The initial search yielded 76 cases that were narrowed to 40 after exclusions. There were 23 (57.5%) cases that were found in favor of the defendant, while 17 (42.5%) cases led to indemnity payment to the plaintiff including two cases (5.0%) that were settled out of court and 15 (37.5%) favoring the plaintiff in front of a jury. The mean settlement received was $335,500 compared with the mean indemnity award of $831,050 for verdicts decided in favor of the plaintiff (P = 0.68). The most common breach of duty was error in surgical decision making, present in 20 cases (48.8%). Informed consent was an issue in 13 filings (31.7%), and postoperative infection was seen in 13 cases (31.7%). In cases that identified the type of implant used, 58.3% were malleable implants, and 41.7% were inflatable devices.

Conclusions: The main issues involved in malpractice litigation for penile prosthesis implants included surgical performance, informed consent, and postoperative management. Urologists must be aware of these potential issues in order to minimize their malpractice liability.