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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

2006 – Research finds 14.6% of men require secondary surgery following penile prosthesis implantation

Posted in Penile Implants

We are no longer accepting cases regarding these products.  Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device.  We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers.  For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.

Penile prosthetic surgery is one option men have who suffer from erectile dysfunction.  These implants can also be used to help manage urinary drainage when penile retraction has inhibited that process.  The surgery required for this implant is delicate and even when performed by a skilled surgeon many serious complications can arise, such as erosion of the prosthetic, infections, and painful reoperations.  Author DH Zermann, from the Department of Urology at The University Hospital, Friedrich-Schiller-University Jena, in Jena, Germany, conducted a study called “Penile Prosthetic Surgery in Neurologically Impaired Patients:  Long Term Follow-Up”, where the purpose of this study was to examine the long term results for men that underwent penile prosthetic surgery.

Zermann states “Between 1980 and 1996, 245 neurologically impaired patients with a mean age of 40.8 years (range 16 to 75), including 188 with paraplegia, 57 with quadriplegia and 197 with spinal cord injuries, were treated for erectile dysfunction and/or urinary incontinence with penile prosthesis implantation.”  Mean time of paralysis was 11.2 years and after a nuero-urological evaluation all the patients were candidates for penile prosthesis implantation.  A follow program was initiated after the treatment in order to document patient satisfaction, problems, and complications.  The study was done over 17 years and 293 surgical procedures were done with the implantation of 147 semirigid, 113 self contained inflatable, and 33 inflatable 3 piece prostheses.  The subjects were divided in three groups, Urinary management only, erectile dysfunction, and urinary management and erectile dysfunction.  The author of this paper further writes that “At a mean followup of 7.2 years (maximum 17) 195 patients were reevaluated in clinic. In 122 patients (90.3%) urinary management problems were resolved. Erectile dysfunction treatment was successful in 76 patients (82.6%). There were 43 revisions for technical reasons and infections.”

This means that 14.6% of patients who used penile implants required painful reoperation.

In all, 12 patients had infection.  The perforation rate was different for each implant: 15 cases for semirigid devices, 2 cases for self contained inflatable, and 0 for inflatable 3-piece devices.  The author of this paper concludes that despite technical advances, many painful complications are still associated with this procedure.

Since these complications are so frequent in the use of penile prosthesis, a number of penile implant lawsuits have been filed in recent decades.

Our Penile Prosthesis Lawsuit Information page is a great place to start if you have any questions about penile prostheses.