"An infection after placement of a penile implant is a potentially dangerous problem. The article below published on ABC news highlights the issues surrounding the controversial case of a Miami urologist who placed a penile prosthesis in a diabetic patient which resulted in a severe infection necessitating penile amputation. Fortunately, infections after placement of penile implants are rare complications. The penile implants that I place manufactured by AMS are antibiotic coated and have an infection rate of less than 1%. Although having diabetes is certainly not a contraindication to placement of a penile implant, certainly having poorly controlled diabetes increases a patient's risk for developing an infection. For this reason, it is important for urologists to pay attention to a patients diabetes control and evaluate the hemoglobin A1c which is an indicator of the patients diabetes control over the past several months. In my practice, if a patient has refractory erectile dysfunction and is interested in a penile implant, but his hemoglobin A1c is elevated, I defer placement of the penile prosthesis until the patient in combination with his primary care physician or endocrinologist is able to improve his patients diabetes control and bring the hemoglobin A1c back down to normal levels. Unfortunately, even under optimal conditions, an infection can occur. The most important factor in the context of an infection of a penile prosthesis is early recognition and intervention to prevent severe complications such as a penile amputation as highlighted in the article below."
A man who elected to have a penile implant in a Florida hospital is now suing his doctor after a post-surgical infection resulted in the amputation of his organ.
Enrique Milla, 65, who was reportedly deported from the United States last year back to his native Peru, has been testifying in court via Skype that the medical procedure robbed him of his dignity and manhood.
In a medical malpractice trial that began this week, Milla claims that his doctors should have known that he was not a good candidate for the procedure because of his diabetes and high blood pressure.
"This has been devastating, painful and embarrassing," said Milla's attorney, Spencer Aronfeld of Coral Gables, according to ABC's affiliate WPLG.
Milla alleges that his anesthesiologist Dr. Laurentiu Boeru "failed to evaluate properly the risks of this procedure." He first filed the lawsuit in 2009, naming Boeru and Dr. Paul Perito, the urologist who performed the surgery.
According to the Miami Herald, which obtained records that are not publicly available, Perito settled the case out of court.
"At the end of the day, he has to sit down to pee through a tube," Aronfeld told the Herald.
Penile implant surgery is most commonly performed after all other treatments for erectile dysfunction have failed. It is also used to treat some cases of Peyronie's disease, a condition that causes scarring inside the penis, leading to bent, painful erections.
Implant surgery comes with a risk of infection, which can occur at any time after surgery -- in rare cases, even years later, according to the Mayo Clinic.
Milla suffered from a number of medical conditions, including erectile dysfunction, according to court records. Milla, who had lived in Miami for 40 years working in a medical supply business, received the surgery in 2007 at Coral Gables Hospital.
"He didn't do this to have a bigger penis," said Aronfeld. "This was because of medical reasons: He just wanted to have relations with his wife."
But two weeks after the operation, Milla developed an infection that eventually turned to gangrene. Amputation of his penis was necessary to save his life, according to his lawyer, who alleges Boeru didn't exercise proper care after the surgery.
"Post-operative period is about anywhere between six to 24 hours after surgery. It does not include either days or months," testified Boeru.
"This is an infection that occurred in this gentleman because he didn't do what he was supposed to do post-operatively nine days after the surgery," Boeru's lawyer Jay Chimpoulis, told WPLG.
He suggested that Milla ignored medical instructions to avoid sex and developed a fecal infection.
"There are any number of ways he could've gotten that. None of them had anything to do with [Boeru]," Chimpoulis said.
Dr. Pravin Rao, director of reproductive medicine and surgery at the Johns Hopkins Brady Urological Institute, said penile implants, called prostheses, are safe for patients who are in good health -- even those with diabetes, as long as the disease is "controlled."
The risk rate is lower than 3 percent, according to Rao, who did not treat Milla.
"Usually, it's the last report option for men who just don't want to use other treatments as options," he said. "Sometimes, the individual wants a permanent solution and wants the spontaneity."
Penile implants are among a "long algorithm of options" for those with erectile dysfunction, according to Rao. Urologists start with pills like Viagra -- the least invasive approach -- to vacuum erection devices and injection therapy.
But sometimes those treatments fail because of the quality of the tissue in the penis or poor blood flow.
The most common reason for ED is chronic disease that affects the vessels in the penis -- most often diabetes, hypertension, smoking or high cholesterol. Nerve damage, caused by spinal cord injuries, diabetes or radical prostate cancer surgery, can also trigger ED.
A poor candidate for a prosthesis is someone who is not in overall good health and may be at risk under anesthesia or not be able to withstand the blood loss of surgery.
"The number one concern is infection, and that's why we make sure their overall health and immune status are good and their diabetes is under control," said Rao.
When infection does occur, the prosthesis must be immediately removed to clear the infection.
"Personally, I have heard of amputation, but not seen one," said Rao. "We have definitely seen prostheses taken out due to erosion. The wrong size is chosen or there is poor wound healing."
The prosthesis is an inflatable device that is inserted in the two tubes of the penis. The balloons can be filled up with fluid, creating an erection. A small pump is placed in the scrotum with a reservoir of fluid that connects to the tubing.
"When we first place it, we don't have it activated to create a full erection," said Rao. "Then after letting it heal for six weeks, [the patient] comes in and we teach them how to use the pump by squeezing it."
Patients are told not to have sex during that recuperative period.
Rao said that penile implants are "very successful and infection is not the norm."
Some studies of patients with diabetes and those without the disease had the same rate of infection. "But," he said. "We have to be prudent about picking the patient."