2025 October FDA Received Malleable Adverse Events

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###Spectra - 1 event

Spectra penile prosthesis lost rigidity, so it was explanted and replaced with a Tactra device; no patient complications were reported.

###Genesis – 8 events

Mechanical events
• Fracture (3 yrs) + malposition with extrusion and fistula: Penile shortening and pain from asymmetric implantation with bilateral cylinder fractures, extrusion, and chronic cavernous–cutaneous fistula; both cylinders removed, corpora repaired, no new prosthesis placed.

Biological events
• Rejection with fistula: After Genesis implant, patient developed painful purulent fistula attributed to implant rejection; fistula treated and implant replaced without complications.
• Infection with explant + replacement
• Infection with explant only
• Intraoperative extrusion: During implantation, the malleable rod perforated soft tissue and extruded; case aborted and no prosthesis placed.

Miscellaneous
• Revision to Tactra: Prior Tube Promedon / Coloplast Genesis prosthesis revised for unspecified reason and replaced with a Tactra implant.

###Tactra - 14 events

Mechanical events
• Tortuous device malfunction: Marked leftward tortuosity and failure to stay erect, causing intercourse pain; mechanical issue confirmed, surgery planned, device still implanted.

Biological events
• Malposition / curvature: Tactra malleable prosthesis reportedly placed incorrectly, causing curvature; revision with IPP planned.
• Fluid discharge: Tactra device associated with fluid discharge; replacement surgery requested.
• Infection after self-injection: Infection occurred after patient injected corpus cavernosum; Tactra removed and IPP implanted.

Miscellaneous
• Concealability / stiffness: Prosthesis caused concealability problems, pain, and inability to bend; Tactra explanted.
• Loss of rigidity: Loss of rigidity at penile base confirmed; Tactra explanted and replaced.
• Patient dissatisfaction (functional): Tactra replaced due to dissatisfaction; IPP implanted without complications.

References:
https://www.accessdata.fda.gov/scripts/ ... search.CFM

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Attaching an executive summary of October 2025 MPP FDA event submissions for Coloplast and Boston Scientific products.