Silicone Implants: Men’s Turn to Worry : Health: For 350,000 impotent Americans, penile implants can make sex possible again. But the recent furor over the safety of breast implants has stirred up new debate about possible risks.
For two decades, men with impotence have had the option of receiving penile implants if other treatments, such as medications or counseling, failed. The devices became greatly popular, and an estimated 28,000 men receive implants each year.
Now, however, concerns are growing over the safety of the devices, which for thousands of men provide the only means for normal sexual functioning.
The U.S. Food and Drug Administration in April announced that manufacturers of inflatable penile implants--the most popular type--would be required to submit scientific evidence of safety and effectiveness.
And soon, the agency will require implant patients to read and sign an informational letter stating the risks involved, including possible immune-system reaction.
The FDA’s action is thought to be the result of its experience with silicone breast implants, which have a high rate of complications and now are only available as part of a government-controlled study. Like breast implants, penile implants arrived on the market before the FDA was given regulatory authority of medical devices in 1976. The agency said it will systematically check all “high-risk” devices that became available prior to 1976.
Inflatable penile implants, which have been around since the early 1970s, are among the first to be scrutinized because they are made of silicone and have generated a high number of consumer complaints--6,500 since 1984. About 350,000 men have implants.
Moreover, recent studies show that the devices fail and may require additional surgery in about one-third of the cases over time.
“I think it’s important for the FDA to know what is really going on with these devices,” says Dr. Myron Murdock, medical director of the Impotence Institute of America. “They were developed around 1973, and the follow-up on these devices has not been what it should be. The manufacturers know very little about what has happened to these patients, and the FDA knows even less.
“For example, what is the percentage of complications and how long does it take on average for these problems to occur? We have a general idea but we need more accurate data.”
But Murdock and other doctors are concerned that the FDA is over-exaggerating possible immune system disorders associated with the implants and may frighten some patients from seeking treatment. The FDA wants to examine whether the silicone in penile implants produces the same type of immune system disorders associated with some breast implant cases.
According to the American Urological Assn., 80% of men with implants are satisfied with the results. For men who have not been helped by other therapies, the AUA recommends implants if the patient understands the risks involved.
However, if the FDA determines manufacturers cannot provide data attesting to the product’s safety and effectiveness, implants could be removed from the market. The FDA’s timetable for reviewing the data has not been determined, says FDA spokeswoman Sharon Snider.
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Impotence is the inability to attain and maintain a penile erection. Since an erection results from a complex interaction between muscles, nerves and blood vessels, it can be affected by a variety of disorders and illnesses, such as diabetes and hypertension. Injuries, certain medications and psychological problems can also lead to impotence, which affects 30 million Americans--mostly older men.
The disorder can be successfully treated in a number of ways, including counseling, usually with the sexual partner present. If the cause is physiological, treatments include injections, medication, implants and a vacuum device (which creates negative pressure around the penis and pulls blood into the organ to produce an erection), says Dr. Leroy Nyberg, of the National Institute of Diabetes and Digestive and Kidney Diseases.
In recent years, many men have had success by injecting drugs into the penis prior to intercourse. And because of this treatment, the use of implants has declined, says Dr. Alan H. Bennett, an Albany, N.Y., urologist and member of the American Urology Assn. committee that recently reviewed the devices.
Penile implants, which cost $10,000-$15,000 and are usually covered by insurance, are often viewed as a last resort because they are the most complicated. An estimated 10% of men who seek treatment for impotence require implants.
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There are several types of implants including rods inserted in the penis and more complicated inflatable devices.
“People like the inflatable device because it’s the closest to natural,” Nyberg says. “It’s hidden, and not noticeable, even with a bathing suit on. The disadvantage is there are some mechanical failures.”
What is not clear is how often the inflatable devices fail or cause complications, such as pain and infection.
Statistics released last week by one manufacturer--American Medical Systems--showed an 18% chance that a patient would require surgery to remove or replace an implant called the 700 CX after five years. The rate for another of its popular implants, the 700 Ultrex, showed that additional surgery was required in 10% of patients after two years, according to the company, a major implant manufacturer based in Minneapolis. Complications that could lead to surgery include infection, leaks, migration of components or mechanical failure.
However, a position paper released in May from the American Urological Assn. advises consumers that inflatable implants fail in 30% of cases over time, with some failures requiring surgery.
According to Denise Ulrich of American Medical Systems, improvements were made to the newer devices, which have curbed the complication rate.
“As the technology of the devices has improved, as well as doctor training and technique, all of that has contributed to a lower complication rate,” she says.
But Dr. Perry Nadig, an impotence expert in San Antonio, says manufacturers have given inaccurate estimates of the failure rate.
“I do think industry has not been forthcoming about the possibility of complications and of informing the physician and the public about what the rate is,” he says. “So I don’t think it’s unreasonable for the FDA now to require data on durability and performance.”
Hoyt Rowell, a Charleston, S.C., attorney who is representing men with legal complaints against implant manufacturers, says he and other attorneys suspect manufacturers of providing inaccurate data.
“I’m hoping by virtue of the FDA investigation and the increasing litigation, that we’re going to see that the manufacturers knew they had tremendous problems with these devices,” Rowell says. “I think we’ll see a much higher complication rate than what has been given to physicians and the public.”
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While the major complaint about penile implants is mechanical breakdown, the devices are also part of a widening controversy surrounding the use of silicone in the body.
The most common complaints of silicone breast implants are hardening of the scar tissue around the implant and the possibility that the silicone gel would break from its sac and migrate. Some experts also suggest that the silicone can cause a severe immune system reaction in some women, causing various forms of autoimmune disease, such as scleroderma and lupus. But that theory is hotly debated.
The FDA has drawn no conclusions as yet about this link. But the agency still cites silicone as a possible problem with penile implants.
“Most of the implants are made of silicone,” says the FDA’s Snider. “Because of that, they do raise some of the same safety concerns posed by silicone breast implants.”
But many urologists criticize the suggestion of silicone reactions among men. Silicone has long been thought to be an inert substance in the body, but some researchers suggest that the form the material is in may make a difference. Breast implants contain gel, which has the ability to migrate to other parts of the body. The silicone penile implant is a hard silicone, Murdock says.
“The (concern) with silicone gel breast implants has no implication whatsoever for the implantation of solid silicone. Solid silicone has been implanted for over 50 years,” he says.
That’s why Murdock says he was opposed to the inclusion of silicone as a risk in the FDA’s informational letter.
“We are dealing with patients who are significantly impotent and not treatable by other means. So you throw at them this unbelievable letter, which is almost using scare tactics. It frightens many of the patients. They are hindering patients who are appropriate and excellent candidates for the implants.”
