(438) An Inflatable Penile Prosthesis Manufacturer Recall: What do the Real Numbers Show from a Single High-volume Center?

Abstract

Abstract Introduction The inflatable penile prosthesis (IPP) is considered the gold standard in the treatment of erectile dysfunction. As such, there have been a multitude of mechanical improvements over the recent decades. Despite these advances, there have been device recalls in the past. Some required revision surgery. A large retrospective study in 1995 from Drs. Wilson and Delk illustrated that revision surgery has an increased risk of infection of approximately 10%. However, this is most likely higher in lower volume institutions. In May of 2020, a major IPP device company released a letter issuing an urgent Class 2 medical device recall for their AMS 700 Momentary Squeeze Pumps (Boston Scientific, Marlborough, MA, USA) due to an increasing number of complaints due to failure of pump activation over a several year period. After investigation, a defective pump mold was found to be the etiology. There were only 2 pump molds; yet it is estimated that only up to 2% of devices would be affected. Objective We aim to investigate the actual device defect rate in clinical practice and to bring to light the cost of revision IPP surgery to our health system and patients. Methods We retrospectively reviewed charts from a single high-volume IPP surgeon from January 2018-December 2020 for virgin and replacement IPP patients. Those having Coloplast devices or malleable implants were excluded. Costs of revision surgery were also researched at the senior author’s facility. Results A total of 154 patients were identified. 42/154 (27%) patients were identified as removal and replacements and 112/154 (73%) were virgin cases. Of the 154 patients, 13/154 (8.4%) patients had pump failure. 5/112 (4.5%) were virgin cases and 8/42 (19%) patients were removal and replacements. These numbers do not include patients that have fickle pumps that were conservatively managed or implants that were identified as defective intraoperatively, which would greatly inflate these numbers. Cost analysis at our institution revealed direct costs that far exceed the price of the replacement device (list price $15,100; average is ~$14,000). However, these direct costs do not include the costs of convalescence, loss of work, or if any complications arise from the revision surgery. Conclusions We found that the stated rate of affected AMS 700 MS pumps to be approximately 4 times greater than previously stated at a rate of 8.4%. Including fickle pumps or grossly defective devices during the index surgery in this analysis would undoubtedly increase these numbers significantly. The company’s recall policy is also limited as it only considers malfunctions brought to its attention within 2 months of surgery. The cost to the patient and/or the hospital system far exceeds the cost of the replacement device itself. Further analysis should be performed. A more expeditious process for evaluating device complaints and more transparency from manufacturers should be implemented to improve patient satisfaction and outcomes. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific, Coloplast, Irrimax, MicrogenDx, Signati Medical, Endo, Pfizer, Procept Robotics