SpaceOAR Lawsuit Alleges Prostate Cancer Treatment Caused Rectal Fistula, Required Colostomy

Lawsuit claims Boston Scientific failed to warn physicians to check for misplaced hydrogel before radiation treatment, increasing the risk of serious rectal injuries.

A Pennsylvania man has filed a SpaceOAR lawsuit alleging a defective hydrogel spacer used during prostate cancer treatment infiltrated his rectal wall, causing severe tissue damage and a fistula that required a colostomy and urinary catheter.

The complaint (PDF) was brought by Daniel Patrick Marchio and Rose Marie Marchio in Massachusetts Superior Court on October 14, naming Boston Scientific Corporation as the sole defendant.

Daniel and Rose Marchio allege SpaceOAR Vue was implanted to protect Daniel’s rectum from radiation exposure, yet the gel entered his rectal wall instead of remaining in its intended location. They maintain that radiation treatment continued even after an MRI revealed the infiltration.

SpaceOAR Risks

SpaceOAR devices are injectable hydrogel spacers used during prostate cancer radiation therapy.

The original SpaceOAR was developed by Augmenix Inc. and received FDA clearance in April 2015. Boston Scientific acquired Augmenix in 2018, and a second-generation version, SpaceOAR Vue, received FDA clearance in July 2019. Unlike the original device, SpaceOAR Vue is radiopaque, making it easier to identify on CT scans.

Because the prostate is located immediately in front of the rectum, radiation targeting cancer cells can also damage nearby rectal tissue. SpaceOAR is designed to separate the organs, reducing radiation exposure to the rectal wall.

Physicians inject the hydrogel between the prostate and rectum using ultrasound guidance, creating a protective barrier throughout radiation treatment. However, some individuals allege the injection site can be difficult to visualize, increasing the risk of gel entering the rectal wall or surrounding tissue.

In light of these concerns, product liability attorneys are investigating SpaceOAR lawsuits alleging Boston Scientific failed to adequately warn physicians about complications from misplaced hydrogel, including rectal ulceration and fistula formation, particularly when radiation continues after infiltration.

SpaceOAR Vue Injuries Following Radiation Treatment

According to the complaint, Daniel Marchio was diagnosed with high-risk prostate cancer in September 2022. Physicians recommended hormone therapy, brachytherapy and external beam radiation, beginning with radioactive seed placement on January 9, 2023, at UPMC Hanover in Pennsylvania.

On March 17, 2023, his urologist implanted SpaceOAR Vue to protect his rectum during radiation treatment. However, an MRI performed 10 days later allegedly revealed that a moderate amount of hydrogel had infiltrated his rectal wall.

Despite those findings, Daniel began external beam radiation on April 3, receiving 25 treatments through May 5.

The Marchios allege Boston Scientific should have instructed physicians to obtain MRI imaging after implantation and postpone radiation when hydrogel infiltration was detected, warning that radiation exposure could increase the risk of ulcers and fistulas.

An August 2023 MRI revealed a fistula at the location of the hydrogel. Although physicians initially attributed the condition to previously undiagnosed inflammatory bowel disease, the Marchios maintain it resulted from radiation exposure following SpaceOAR infiltration.

In April 2024, doctors at Penn State Health Milton S. Hershey Medical Center confirmed a large rectourethral fistula, an abnormal connection between the rectum and urethra.

Daniel underwent surgery on April 25, requiring a colostomy bag to divert stool and a suprapubic catheter to drain urine directly from his bladder. Both procedures were intended to prevent waste from passing through the injured area.

Following additional examinations and catheter exchanges, Daniel was allegedly advised in August 2024 that pelvic reconstructive surgery was the only possible treatment for the fistula.

The lawsuit indicates Daniel has incurred more than $300,000 in medical expenses. However, the Marchios maintain they did not discover the alleged connection between SpaceOAR Vue and his injuries until April 2026.

Lawsuit Claims Boston Scientific Failed to Warn About SpaceOAR Risks

Daniel and Rose Marchio allege Boston Scientific failed to adequately warn physicians about SpaceOAR complications, including rectal wall infiltration, ulceration, fistulas and injuries requiring colostomy or urinary diversion.

The complaint also claims SpaceOAR Vue was defectively designed because the hydrogel can infiltrate the rectal wall, its placement is difficult to control and misplaced material cannot be easily removed.

According to the lawsuit, Boston Scientific knew about significant infiltration and fistula risks by January 2023 but failed to provide adequate warnings or instructions for MRI evaluation following implantation. The Marchios also claim some major medical centers have stopped using SpaceOAR because of safety concerns.

“The SpaceOAR Vue is defective because the risks inherent in the product design outweigh the utility or benefit derived from the product.”

— Daniel Patrick Marchio et al. v. Boston Scientific Corporation

The lawsuit raises claims involving defective design, failure to warn and negligence, seeking compensatory and punitive damages, among other relief.

Rose Marchio also seeks damages for loss of consortium, alleging her husband’s injuries have affected their marriage, companionship and household responsibilities.

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