FDA OKs Inflatable Penile Prosthesis for Erectile Dysfunction

The FDA approved the Titan Prime inflatable penile prosthesis for men with erectile dysfunction, Coloplast announced on Wednesday.

This prosthesis is indicated for men who are considered to be candidates for implantation of a penile prosthesis, and is “designed to emulate the appearance and performance of a natural erection, supporting device performance for patients, surgeons, and partners,” the company said.

The device is made with a proprietary material called Bioflex — a polymer engineered for greater strength and durability than silicone — and is implanted through a single outpatient procedure.

Patients should expect a recovery time of 4 to 6 weeks after implant before they can resume sexual activity.

A systematic review and meta-analysis published in 2022 reported that the median survival time of inflatable penile prostheses is approximately 20 years, with a device survival of 93.3% at 1 year, 91% at 3 years, 87.2% at 5 years, 76.8% at 10 years, 63.7% at 15 years, and 52.9% at 20 years.

The Titan Prime prosthesis is contraindicated in patients who have an active infection present anywhere in the body, especially a urinary tract or genital infection, a documented hypersensitivity or allergic reaction to silicone or polyurethane, unresolved problems affecting urination (such as elevated residual urine volume secondary to bladder outlet obstruction or neurogenic bladder), and those unwilling to undergo any further surgery for device revision.

Warnings include the potential for re-surgery, and the possible increased risk of infection in diabetic and immunocompromised patients that could result in permanent damage to tissue/organs.

Adverse events that can occur with penile prosthesis procedures and implants (and which may require revision surgery or device removal) include acquired phimosis, adhesions, bladder storage symptoms, capsular contracture, deformity, delayed/impaired/abnormal wound healing, discomfort, erosion/extrusion, fistula, foreign body reaction, hematoma/seroma, hemorrhage/bleeding, hernia, hypersensitivity/allergic reaction, induration, infection, inflammation, male dyspareunia, necrosis, obstruction/occlusion, pain, scar tissue, sexual dysfunction, tactile disorders, urinary incontinence symptoms, urinary tract infection, voiding symptoms, and perforation or injury of soft tissue, structures, or organs.

The Titan Prime inflatable penile prosthesis will be available in the U.S. later this year.