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

2009 – Scrotal Hematoma, Infection, Material Migration, and Surgical Revision Associated with Penile Prostheses

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 prostheses have been invented to treat several penile ailments, and often, these ailments are typically a result of a physical malady of the penile structure.  Prosthetics are generally only implanted when natural remedies and medications have failed to correct the condition.  Like many other surgical procedures, penile prosthetic implantation has been associated with various complications.  In recent years, the medical community has worked to study the risk factors associated with the occurrence of such complications.

One study on the complications of penile prosthetic implantation was conducted in France by I Souillac et al. The title of the study, translated from French, is “Inflatable penile prostheses: results, complications and prognostic factors.”  The study was published in the French journal Progrès en Urologie in 2009.  The study was conducted “To identify the main prognostic factors influencing the immediate and long-term results of inflatable penile prosthesis implantation.”

The study included 96 patients, with an average age of 54.4 years, and 118 total inflatable penile prosthetic implants.  The same operator carried out all procedures.  Among the patients in the study, 1/3 had undergone previous penile surgery.

Follow ups were conducted on all of the patients.  One patient, who also suffered from sickle-cell disease, died from a “massive pulmonary embolism”.  Several other patients suffered from complications including “Seven patients (7.3%) had a postoperative scrotal [hematoma]. Eleven patients (11.5%) had a postoperative infection. Fourteen patients (14.6%) had a material migration. Sixteen patients (16.7%) had a surgical revision for mechanical dysfunctions after a mean period of 21 months.”  Additionally, complications were much more frequent among patients who had previously undergone penile surgery or suffered from Peyronie’s disease.  After all of the procedures, 85% of the total patients had functional prosthesis, first time implantation recipients experienced a 91% success rate.

Ultimately the authors concluded, “The long-term functional results of inflatable penile prosthesis are suitable but the postoperative complications are frequent in case of prior penile surgery, associated surgical procedure, Peyronie’s disease, or post priapism implantation.”

Due to the fact that many of the men who used penile implants did so unaware of the risks associated with penile prosthesis surgery, penile implant lawsuits were filed in great numbers.

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