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.

Erectile dysfunction is a medical condition that plagues millions of men in the united states alone.  When the pharmacologic route doesn’t adequately solve the problems seen with erectile dysfunction, men may turn a penile prosthesis implant for the solution.  There are several different types of implants available on the market today, but the most commonly used penile prostheses are those manufactured by American Medical Systems (AMS).  The surgery required for these implants are delicate by nature and are often accompanied with serious complications such as infections and painful reoperations.

Author A. Natali from the Uro-Andrological Unit within The Department of Urology at University of Florence, in Florence, Italy, conducted a study called “Penile Implantation in Europe:  Successes and Complications with 253 Implants in Italy and Germany”, where the goal of the study was assess complications and patient satisfaction with AMS penile implants.  The study consisted of 253 consecutive patients who had clinically diagnosed erectile dysfunction.  Natali A. states “Pre, intra- and postoperative data were obtained from chart review, with a mean follow-up of 60 months; 200 patients were available for evaluation. Patient satisfaction data were collected using the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire.”  Major postoperative complications were seen in 20 percent of the patients.  In all, 9 men experience prosthesis infections, 18 had mechanical failure, and 13 men experienced erosion of the prosthesis.  Natali A. further states “ Partner satisfaction with the AMS 700CX, AMS Ambicor, and AMS 600-650 was 91%, 91%, and 75%, respectively; dissatisfaction was 0%, 5%, and 6%, respectively.”  The study noted that patients claimed they had more natural erections than before the operation, but hardness was the same as before.  The use of standardized assessment tools for patient satisfaction will allow future comparison of data between different centers performing similar penile prosthesis implants.

Due to the fact that many men have used AMS penile implants that required reoperation, unaware of the risk for infection or complications, a number of AMS penile implant lawsuits have been filed.

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

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.
.

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.

A penile prosthesis and other similar types of treatment are forms of treatment for men with erectile dysfunction.  The prostheses used are bendable or inflatable.  Some basic types of prosthesis consist of a pair of bendable rod like structures that can be surgically implanted within the erection chambers of the penis.  The most common types are manufactured by American Medical Systems, and are used for a wide variety of patients.  The use of these implants are usually used when there is a clear medical cause for ED and when the problem is unlikely to resolve or improve naturally or with other medical treatments.  Certain medical conditions may create the need for the use of these penile implants: for example, when scarring has caused an erection to curve, we see prosthesis implanted during surgery to reconstruct the penis; this is called peyronie’s disease.

Many times, these implants require painful secondary penis surgeries and infections are so bad that the implants have to be removed.  Sometimes, reoperation is required and infections are not a rare occurrence.  While the newer penile implant designs are more reliable than their earlier predecessors, there are still cases of implant malfunction.  When this occurs it requires surgery to remove or repair the broken implant.  Internal erosion or adhesion is a serious problem that may lead to a serious infection.  An implant might stick to the skin or rub away the skin of the penis from the inside and could break through the skin.  In 1983, medical researcher CC. Carson, wrote a report titled “Inflatable Penile Prosthesis:  Experience with 100 patients”, where he reviewed the experience and complications that men had with their penile prosthesis implants.  An inflatable penile prosthesis was implanted for the treatment of chronic erectile dysfunction over a two year period.

Carson states “Each patient was thoroughly evaluated by history, physical examination psychologic investigation, and appropriate laboratory testing. Of these patients, the most common indication for prosthesis implantation was diabetes mellitus of adult onset, followed by vascular disease and radical pelvic surgery.”  Mechanical complications and malfunction occurred in 12 of 100 patients and these complications were surgically corrected in secondary operations.  Diabetes raises the risk factors associated with these procedures and the study found that one diabetic patient had an infection that required the removal of the implant.

Due to the high rate of complications associated with penile prostheses, a number of penile prosthesis lawsuits have been filed.

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

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.

The use and implantation of penile implants are hard decisions that many men have to make.  We see these implants used when the pharmacologic route does not work or does not sufficiently solve the patient’s problems.  Author XW Zhu from the Department of Urology at The First Affiliated Hospital, Zhejiang University School of Medicine, in Hangzhou, China, worked on a study called “Prevention and Treatment of the Complications of Inflatable Penile Prosthesis Implantation”, where the objective of the study was to report on the process of making the three piece inflatable penile prosthesis better and identify ways to prevent complications commonly associated with the implant.   The implantation of an inflatable penile prosthesis is a complex procedure that requires careful surgical technique.  Even when these procedures are done by a skilled and experienced surgeon, many serious complications can arise, such as infections, erosion of the implant, and painful reoperations.  Prior to an operation, thorough evaluation of patient history, physical examinations, psychological investigations, and appropriate laboratory testing needs to be done to ensure minimal risk of complications.

Certain medical conditions such as diabetes mellitus, vascular diseases, and radical pelvic surgery may put the patient at a greater risk for complications which may lead to corrective surgery.  In all, 32 patients were with moderate to severe erectile dysfunction, received three piece IPPs.  Zhu XW. States “The surgical techniques were ameliorated in the course of operation. The patients were guided in using the IPP after operation. The effects and complications of the implantation were observed based on IIEF of the patients before and after operation.”

For most of the patients in this study, sexual life continued with little to no complications.  4 of the men in this experiment experienced certain complications that included pump failure, urethral perforation, and penis contractions.  A second operation was needed to achieve normal sexual intercourse.  Occurrence rate of complications in this study was 12.5 percent and sexual intercourse satisfaction was 87.5 percent.

Due to the high rate of complications seen with penile prostheses, a number of penile implant lawsuits have been filed.

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

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.

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.

Millions of men today suffer erectile dysfunction.  A penile prosthesis and other similar types of treatment are forms of treatment for men with erectile dysfunction.  The prostheses used are bendable or inflatable.  Some basic types of prostheses consist of a pair of bendable rod like structures that can be surgically implanted within the erection chambers of the penis.

Penile implant surgery is a risky and sensitive procedure, often accompanied with serious infections and painful reoperations.   Many procedures involving these penile prostheses are accompanied with high rates of postoperative complications, and while the newer penile implant designs are more reliable than their earlier predecessors, there are still cases of implant malfunction.  Certain health factors such as diabetes can increase the risk for postoperative complications.  A thorough physical examination from your doctor will ensure you are a suitable patient for a penile prosthesis and can lower the risk factors involved.

Author Y. Deuk Choi from the Department of Urology and Institute of Andrology, at Yonsei University, College of Medicine, in Seoul, worked on a study titled “Mechanical Reliability of the AMS 700 CXM Inflatable Penile Prosthesis for the Treatment of Male Erectile Dysfunction”, where the goal was to review their experience with the AMS 700CXM prosthesis and assess postoperative complications and reliability.  Deuk Choi states “The AMS 700CXM inflatable penile prosthesis with medium controlled expansion cylinders was introduced in 1990 to provide a device with controlled expansion in girth and fitness for Asian men.”  The study was done from January 1991 to April 1999 and included 273 subjects with erectile dysfunction who had primary penile prosthesis implants.  Medical records and telephone interviews were used after the operations to assess function status of the prosthesis.  Age of the patients ranged from 24 to 78 years of age and the mean follow up was 49 months.  28 complications were reported, 8 were non mechanical and 20 were mechanical.  Infection, erosion, surgical complications, and tube kinking were included in the non mechanical complication group.  Mechanical complications that were seen included cylinder tears, pump failure, and reservoir tears.  Deuk Choi Y. further explains “Mechanical reliability of the device was 98.2% after 2, 95.7% after 3 and 90.4% after 5 years.  The AMS 700CXM is suitable for Asian men and its mechanical reliability is excellent. However, more device modifications are needed to guarantee good reliability during long-term followup.”

Because many men have used penile implants by American Medical Systems unaware of the risks associated with these prostheses, a number of penile prosthesis lawsuits have been filed against the company.

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

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.

For some men, the only way to correct erectile dysfunction is through the implantation of a penile prosthesis.  The surgery required for these implants is delicate and serious complications such as mechanical failure, protrusion of the implant through the skin, and infections can occur.  Sometimes, painful reoperation may the only way to reverse these negative complications.

Author WL Furlow from The Department of Urology at Mayo Clinic worked on an article called “Implantation of Model AMS 700 Penile Prosthesis:  Long-Term Results”, where the goal was to review how certain adjustments made to AMS 700 penile prostheses (American Medical Systems) improved device use and patient satisfaction with the procedure in general.

Furlow states that “the American Medical Systems inflatable penile prosthesis has undergone periodic design changes to improve device reliability and longevity while maintaining a high degree of patient and partner satisfaction.”  Past studies done on the AMS 700 penile prosthesis did not take into account the changes made to the design of the implant, so assessment of the reliability may have been skewed.

In all, 120 patients were evaluated who had been implanted with the AMS 700 inflatable penile prosthesis; using the same inflatable prosthesis in all evaluations made it possible to determine the positives and negatives of this one type of implant.  Just over 11% of patients required revision surgery to correct complications that arose after surgery, but the review found that the model 700 implant has a 97 percent chance of working for at least 3 years without mechanical failure.

Due to the fact that many men have entered into penile prosthesis surgery unaware of the rate at which revision surgery is required, a number of penile implant lawsuits have been filed around the country.

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

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 prosthesis implantation surgery is a serious operation, but can help with erectile dysfunction and other ailments.  Even when the operation is being done by a skilled surgeon, it is not uncommon for serious complications to arise.  In many cases, the only way to correct the problems that come with these surgeries are reoperations that can be painful.  Complications range from protrusion of the implant through the skin to serious infections and mechanical failure.

Author I. Moncada, from the Departments of Urology and Andrology at Hospital La Zarzuela in Madrid, Spain, worked on a study titled “Inflatable Penile Prosthesis Implantation Without Corporeal Dilation:  A Cavernous Tissue Sparing Technique”, where the purpose was to determine if dilation of the corpora cavernosa before implanting the penile prosthesis results in more favorable outcomes.  (The corpora cavernosa is a spongy part of erectile tissue that fills with blood during a penile erection.)

The study included patients who used an AMS 700CX or an antibiotic coated 700CX InhibiZone 3-piece prosthesis.  Moncada states “They were randomized to penile implantation without (group 1) or with (group 2) penile dilation. Postoperative pain was measured on the day after surgery and at day 7 postoperatively.”  Pain and postoperative complications were similar across both groups.  In all, 100 patients were used in this study, and they were asked to help with the follow-ups by recording penile length and girth during sexual stimulation.  Complications seen were problems during the operations and pain after the operation.

Further, “Immediately postoperatively, and at 3 and 6 months penile length was significantly greater in group 1 than in group 2” and “Mean International Index of Erectile Function scores were higher in group 1 (12, range 10 to 14 vs 7, range 6 to 8).”  As such, the researchers did not conclude that penile dilation was necessary.

Due to the fact that a number of men have entered into penile prosthesis surgery unaware of the risks associated with the use of these devices and their implantation, a number of penile implant lawsuits have been filed around the world.

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

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 prosthesis operations are delicate surgeries that attempt to help men overcome erectile dysfunction.  These implants come with many possible complications that may include infection or malfunction of the implant which can require painful reoperations.  Author D. Droggin from the Department of Urology at University of Columbia, New York, worked on a study titled “Antibiotic Coating Reduces Penile Prosthesis Infection”, where the main goal was to determine how well a new antibiotic-coated penile prosthesis inhibits infection by reducing bacterial adhesion.

The study observed the medical records of three groups of patients who used three different types of penile implants.  The first type of implant observed was the American Medical Systems (AMS) inflatable penile prosthesis, the second was the AMS antibiotic-coated prosthesis, and the third type was the AMS nonantibiotic-coated prosthesis.  Droggin states “A total of 152 men aged from 27 to 79 years with erectile dysfunction underwent implantation of the AMS inflatable penile prosthesis. Fifty-eight patients received the antibiotic-coated prosthesis between July 2001 and November 2003, and 94 patients received the nonantibiotic-coated prosthesis between July 1990 and June 2001.”

Results from the study showed that most of the patients had reported that some degree of infection occurred.  The infections were seen as soon as 1 day and up to 6 months after the operation.  Surgery was required to correct the infections for 15 of the patients who used the prostheses not coated with antibiotics, and no infections were found with patients who used the antibiotic-coated prosthesis implants.  The researchers and authors of this study conclude that antibiotic-coated prosthesis can inhibit the growth of bacteria on the prosthesis and reduce the risk of infections.

Unfortunately, many men use penile implants not coated with antibiotics, and are thus prone to infection.  Infection and complications are risks accompanying all surgical procedures, but what is most important is that the manufacturers of the medical devices used make all patients and doctors aware of the rate at which these risks are associated with the implantation of their product.  Sadly, this has not been the case with American Medical Systems and their penile prostheses, and many men have entered the surgery unaware of the rate at which reoperation is required and at which complications occur.

As a result of this, a number of men have chosen to file penile implant lawsuits.

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

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 prosthesis implants require delicate surgeries, and complications that lead to serious medical conditions may occur, including infection, protrusion of the implant through the skin, and mechanical failure of the device.  In many cases, the only way to correct problems that arise from complications are secondary, revision surgeries.  Author KH Ferguson from the Department of Urology (MCSU) at Wilford Hall Medical Center at Lackland Air Force Base in Texas, conducted a study titled “Prospective Long-Term Results and Quality-of-Life Assessment After Dura-II Penile Prosthesis Placement”, where the objective was to study the long term reliability of the Dura-II malleable penile prosthesis.  The study also looked at how satisfied the patients were with the results of their implants.

Ferguson states that “Between 1992 and 1996, 94 patients underwent Dura-II implantation for erectile dysfunction. Patients were prospectively examined and completed standardized questionnaires regarding sexual activity, prosthesis function, intercourse satisfaction, and overall quality of life.”  In order to eliminate possible bias of interpretation of the results, the study hired an outside statistician, apart from the original study team.  On average, the patient age for this study was 63 years old and they got a follow up after 5.7 years.  Eighty-five patients were included in the follow up to begin, but sadly 14 patients passed away during the course of the follow-up evaluation.

It was found that eight prostheses (of 94) had to be removed due to complications after implantation.  No mechanical failures were reported and 87 percent of the patients reported they were happy with the rigidity of the implant and felt the operation improved their quality of life.  Ease of concealing these implants is important and overall, it was reported that this was not a problem.  Author Ferguson concludes that most of the patients used in this study would undergo the surgery again after knowing what it includes, and states “The Dura-II malleable penile prosthesis provides good rigidity, ability to conceal the device, and mechanical reliability, as demonstrated by the results of this long-term study.”

Due to the fact that many men enter into penile prosthesis surgery unaware of the fact that between about 4 and 12 percent of the time penile implants require revision surgery, a number of penile implant lawsuits were filed.

 

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

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.