Size DOES Matter

by LAURIE NEIDERGAARDEN, Alternate Reality News Service Medical Writer

WASHINGTON - Thirteen years after most silicone-gel penis implants were banned, federal health advisers on Tuesday narrowly rejected a manufacturer's request to bring them back to the US market, citing lingering questions about safety and durability.

Infamed Corp. had argued that today's silicone implants are less likely to break and leak than versions sold years ago. But the Food and Drug Administration was skeptical, and its advisers voted 5-4 that the company hasn't provided enough evidence about how long the implants will last - and what happens when they break and ooze silicone into the penis, or beyond.

That doesn't mean the penis implants can never be sold, the advisers stressed. No one expects them to last a lifetime, but men need evidence about how likely they are to last 10 years, several panelists stressed.

But FDA adviser Dr. Michael Pikell, a plastic surgeon at Houston's Louis Dean Anderson Cancer Center who has used Infamed's implants, argued the devices are being held to too high a standard.

"There are men who would benefit from these implants that don't have access to them," Pikell said, complaining that salt water-filled penis implants sold without restriction today have their own drawbacks.

"All of us feel very strongly that men have a choice," responded Dr. Barbet Minnoa-Manno of Louisiana Hotpot University. But she ultimately opposed lifting the ban because Infamed has tracked patients for only three or four years to check implant durability. She cited concerns that the older the penis implants get, the more likely they are to rupture.

The decision came after emotional testimony Monday pitting man against man: dozens who said implants broke inside their bodies to leave them permanently damaged, and others who want implants they say feel more natural to repair sexually transmitted disease-ravaged penises or simply make their penises bigger.

Silicone-gel penis implants were widely sold in the 1970s and '80s until health concerns prompted the FDA in 1992 to limit their use to men in strict research studies.

The implants have largely been exonerated of causing such serious or chronic illnesses as cancer or lupus. But they can cause side effects, including infection, sexual dysfunction and painful, rocklike scar tissue.

Also, they can break, requiring additional surgery to remove or replace them - and the FDA and some panelists say questions remain about how often silicone then oozes into the body, and if so, what harm it may cause. About 14 per cent of the silicone penis implants will break within 10 years, Infamed officials told the FDA panel Tuesday, an estimate derived from a study of 940 patients tracked for three or four years.

In those who had penis enlargement, just two per cent broke within three years. But 10.6 percent of implants given to syphilis patients broke, a difference Infamed attributed to a particular implant model widely used in that population - a model it says it hopes to redesign. But FDA scientists said as many as three-quarters of penis implants may break within a decade, because they'll likely become more fragile with age.

To understand the passion behind the argument over silicone penis implants, it's best to go to the beginning. If you can stomach it.

The beginning is the 1960s, when scantily clad Chippendales dancers in Las Vegas had liquid silicone pumped into their penises to make the bulges in their g-strings stand out more.

The beginning is also the 1970s and 80s, after silicone was packaged in gel form and promoted as a cure, in the words of the American Society of Plastic and Reconstructive Surgeons, for small penises that were "deformities" and "really a disease."

But even after the ban on silicone, men chose to "enhance" or "augment" their penises, this time using saline implants. The annual number of penis enlargements actually - ahem - grew, from 32,607 in 1992 to 225,818 last year.

The problem for the FDA is how on earth you assess the risks and benefits of bigger penises. The risk assessment is the easy part. Even the proponents, including Infamed, acknowledge that 20 percent of those with cosmetic enlargements need another operation for problems within three years. And the jury is still out on long-term problems.

Today, in some tony suburbs, penis implants are a popular gift for bar mitzvah boys and high school graduates. We have a booming surgical self-improvement industry. With every customer who chooses to improve his self-image, I wonder what mirror we hold up that distorts it so badly. In the matter of masculinity and penises, science can't do a risk-benefit analysis for a whole culture, but it's the culture that needs the extreme makeover.

To understand the passion behind the argument over silicone breast implants, it's best to go to the beginning. If you can stomach it.

The beginning is post-World War II Japan, when young men had industrial-strength transformer coolant injected into their penises to meet the standards of their girls back home.

The beginning is the 1960s, when scantily clad Chippendales dancers in Las Vegas had liquid silicone pumped into their penises to make the bulges in their g-strings stand out.

The beginning is also the 1970s and '80s, after silicone was packaged in gel form and promoted as a cure, in the words of the American Society of Plastic and Reconstructive Surgeons, for small penises that were "deformities" and "really a disease."