Couple Sues Boston Scientific Over Hydrogel Implant
A Pennsylvania couple alleges that a Boston Scientific device caused severe tissue damage during prostate cancer treatment.
Updated on Oct. 21, 2026 in Healthcare
Daniel Patrick Marchio and Rose Marie Marchio filed a lawsuit in Massachusetts Superior Court claiming a SpaceOAR hydrogel implant infiltrated the patient's rectal wall. The complaint alleges the device caused severe damage and required a colostomy.
Why it matters
The lawsuit centers on claims that Boston Scientific failed to adequately warn physicians to verify proper hydrogel placement before proceeding with radiation therapy. This litigation highlights risks associated with using hydrogel spacers designed to protect the rectal wall during prostate cancer treatment.
Boston Scientific acquired Augmenix, the original developer of the hydrogel, in 2018. The SpaceOAR Vue device, which is the subject of the complaint, received its FDA clearance in July 2019.
The players
Boston Scientific
This major medical device manufacturer produces a wide array of products, including technology for urology, endoscopy, and interventional cardiology.
Daniel Patrick Marchio
He is a plaintiff in the lawsuit who underwent prostate cancer treatment involving a SpaceOAR hydrogel implant.
Rose Marie Marchio
She is a co-plaintiff in the complaint filed against Boston Scientific regarding her husband's medical treatment.
The details
The plaintiffs allege that radiation treatment continued even after an MRI scan identified that the hydrogel had been misplaced. The resulting complications necessitated a colostomy and the use of a urinary catheter for the patient.
Timeline
April 2015: Original SpaceOAR device received FDA clearance.
2018: Boston Scientific acquired Augmenix.
July 2019: SpaceOAR Vue received FDA clearance.
October 14, 2026: Lawsuit filed in Massachusetts Superior Court.
Market Landscape
The lawsuit arrives following the 2018 acquisition of Augmenix by Boston Scientific, which brought the hydrogel spacer technology under the manufacturer's control. Legal actions such as this are common in the medical device industry as manufacturers face scrutiny regarding the long-term clinical outcomes of their specialized treatment products.
This case underscores the potential medical risks that patients should discuss with their physicians before undergoing procedures involving hydrogel spacers. While this specific lawsuit is ongoing, it may influence how hospitals and surgeons communicate treatment risks to patients undergoing prostate cancer radiation.
The takeaway
Patients preparing for prostate cancer treatment should confirm that their care team performs thorough imaging to verify the placement of any hydrogel spacers before radiation. Understanding the specific components of your medical plan can help ensure you are aware of both the benefits and the potential risks of the procedure.
Further reading
Learn more about the latest developments in the Healthcare sector.
Source note: This article includes information reported by AboutLawsuits.
