Lawsuit Alleges Boston Scientific Urinary Sphincter Failed, Required Additional Surgery

Studies have determined that parts of the implant have a high failure rate, yet lawsuit indicates the Boston Scientific urinary sphincter risks are not adequately disclosed.

A California dentist has filed a product liability lawsuit, claiming he was implanted with a Boston Scientific urinary sphincter that suffered a “catastrophic failure” due to a defective design, causing severe pain and urinary incontinence.

The complaint (PDF) was originally brought by Malek Mansour in California state court on January 6, naming Boston Scientific Corporation as the defendant, and was removed to the U.S. District Court for the Central District of California on May 8.

The lawsuit involves the Boston Scientific AMS 800 Artificial Urinary Sphincter, a fluid-filled implant first approved by the U.S. Food and Drug Administration in January 2015, to help men control urine flow after prostate surgery or other conditions that weaken the urinary sphincter. The device is designed to keep pressure around the urethra to prevent leakage, then temporarily open when the user activates a small pump to urinate.

According to the complaint, the AMS 800 system includes a pressure-regulating balloon, a cuff placed around the bladder neck or urethra, and a soft pump implanted in the scrotum. When the pump is squeezed, fluid moves out of the cuff, allowing urine to pass. Afterward, the cuff refills and closes again to restore continence.

Boston Scientific Urinary Sphincter Lawsuit

Mansour’s lawsuit states that he was first implanted with the AMS 800 in May 2019, and was told that the device was expected to function for at least 10 years.

“Less than three years after Plaintiff underwent the surgical implantation of an artificial urinary sphincter at Keck Hospital of USC in Los Angeles, California, the implanted device failed catastrophically, causing severe urinary incontinence, pain and distress.”

– Malek Mansour v. Boston Scientific Corporation et al

Due to the device failure, Mansour had to undergo revision surgery in January 2023 to remove and replace the implant. However, the lawsuit states that he was not told the device was known to have a high failure rate, which Mansour claims Boston Scientific knew about, but decided not to warn the medical community or patients undergoing the procedure.

Clinical research from the Keck School of Medicine allegedly shows that the problems are with the urethral cuff, which is smaller than similar devices. A 2019 study indicated the cuff was more than seven times more likely to fail when compared to similar devices.

As a result of his injuries, Mansour indicates he suffered significant physical pain, emotional distress, major changes to daily activities and had to cancel a prepaid vacation due to the device failure. The filing states he will continue to accrue medical expenses and experience physical and mental pain and suffering into the future.

The lawsuit presents claims of design defect, manufacturing defect, failure to warn, negligence, breach of warranty, negligent misrepresentation, fraudulent concealment and unlawful business practices. It seeks both compensatory and punitive damages, and is also calling for injunctive relief by forcing the device to carry the appropriate warnings or design changes.

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