Busted - April 2005 W magazine

[Guest guest]

Note: forwarded message attached.

Here we go again, another New and Improved implant.

Thanks Myrl and Pam.

>>>The implant industry disagrees. “The cohesive gel does fit into the new and improved category,†says Dan Cohen, vice president of global, corporate and government affairs for Inamed, and implant manufacturer. “It’s demonstrably better.â€<<,

Kathy Nye

Subj: Busted - April 2005 W magazine

Date: 6/2/2005 9:04:34 PM Eastern Standard Time

From: myrlj@...

Thanks to Pam Dowd for sending us the following article. . .Myrl

BUSTED

Natasha Singer

(Copyrighted April 2005 W magazine)

Will the advent of “gummy bear†breasts lift the stigma from silicone implants?

Plastic surgeon Teitelbaum recently FedExed me a box of breasts. There’s a pair of saline implants that feel like water balloons—when I shake them, they slosh. There are several silicone-gel models that are soft and wobbly, like grape jelly. But the piece de rubbery resistance is a new and reportedly improved silicone implant that springs back like a stress ball after I squeeze it. Already in use for a decade in Europe and recently submitted to the Food and Drug Administration for preliminary approval here, the newcomer has a cuddly, sugarcoated nickname: the “gummy bearâ€. While doctors say other implants may slacken over time and may be prone to leakage and rupture, “gummy bear†(also known as anatomic high-cohesive silicone-gel implant) are denser than their rivals and designed to maintain shape better. Plastic surgeons like Teitelbaum haven’t been this excited since the invention of liposuction.

“I love them!†enthuses the Santa , California, doctor, who has already implanted 125 women with the firmer silicone gels as part of clinical trials for three manufacturers. “But I hate the term ‘gummy bear’ because it implies small and hard. These are soft and malleable, more like gummy worms.†Teitelbaum rhapsodizes. “I have more control over them. And, of course, I want an implant that doesn’t leak.â€

Leaking, it turns out, is just one of the problems that surgeons say have plagued implants over the years. Although breast augmentation is among the most popular cosmetic procedures—it ranks third after liposuction and nose jobs, according to the American Society of Plastic Surgeons—mammoplasty also has one of the highest complication rates. One third of the women in an FDA study from 2000 reported that they had undergone at least one subsequent surgery in which an implant was removed or replaced due to problems—a statistic that activists say would not be tolerated for cars or toasters. “Breast implants do NOT last a lifetime,†the FDA warns in its Breast Implant Consumer Handbook 2004. “You should be prepared for long-term follow-ups, reoperations to treat complications and personal financial cost.â€

Plastic surgeons are hoping that the “gummy bear†(which manufacturers say may not be readily available here until at least 2006) will be a less complicated and more long-lived product, but if the high cohesive does prove more effective it will represent a rare advance in the long and troubled history of breast augmentation.

As Nora son relates in her book <I style="mso-bidi-font-style: normal">Cleavage, breast implant technology tends to follow a cycle of “innovation, modification and disillusion.†The idea of augmentation dates back to 1899, when an Austrian surgeon tried paraffin breast injections. The results were less than stellar: Some patients ended up with tumors and skin eruptions; others died. In the 20th century, according to son, other materials inserted to increase perkiness and volume included glass balls (ouch!), nylon, Plexiglas and polyvinyl. In postwar Japan liquid silicone injections resulted in lumps and inflammation. Meanwhile, in the United States, according to the aforementioned FDA handbook, a manufacturer removed polyurethane foam-covered implants from the market in 1991 after it was discovered that their coating degraded, releasing a potentially carcinogenic chemical. More recently, after British women who tried soybean-oil implants started complaining of swelling, inflammation and rancid odor, the Medical Devices Agency (the UK equivalent of the FDA), concerned that the leaking material might be toxic, issued a hazard notice in 2000, suggesting all patients have the implants removed.

And then, of course, there is the saga of silicone implants. In 1992, after allegations that linked leaks and ruptures to symptoms resembling autoimmune diseases, the FDA declared a moratorium on them, citing manufacturers for failing “to provide adequate evidence that they are marketing a safe product.†In the years since, silicone implants have been considered “investigational devices†available only to patients undergoing reconstruction after mastectomies, women with congenital chest defects and mammoplasty patients with problem implants who agree to participate in a study. Only the saline implant, a rubbery silicone shell that is inserted into the breast and then inflated with salty water, has been widely available. The problem: Doctors say saline implants often spring links and collapse like flat tires—a malady surgeons term “deflationâ€.

“One of my patients had three deflations on the same side and another just had her fourth,†reports Beverly Hills plastic surgeon Lesley H. s. And deflation isn’t the only reason he’s had to replace failing saline implants. “Over time, the breasts get smaller and squishy, like water beds,†he says.

Many doctors also have aesthetic quibbles with saline. “The saline implant can feel line a water balloon. It’s much firmer than a natural breast,†opines Mark Berman, a Santa otolaryngologist who is also certified by the American Board of Cosmetic Surgery. He adds that saline implants may also cause “permanent rippling, vertical creases or scalloping around the edges of the breast.

As a rule, plastic surgeons prefer the silicone-gel implant (a silicone rubber envelope that comes pre-filed with the free-flowing silicone.) And because extensive research never proved a link between inflammatory symptoms reported by women with silicone implants and specific autoimmune diseases, many surgeons hope that, after the FDA’s General and Plastic Surgery Device Advisory Panel convenes this month, the moratorium will be lifted. “Silicone feels better and, and for thin women, it looks better,†says s.

For reasons of both looks and longevity, other doctors however, aren’t sold on silicone—at least the looser silicone used in older implant models. “Lying down, the old saline and silicone implants are round and flat like M & M’s,†says Teitelbaum, “but when you stand them up on their sides, gravity causes the liquid to fall to the bottom.†That’s where “gummy bears†comes in. Surgeons hope that the more solid gels will provide the tactile benefits of silicone without sagging and seepage.

“The new silicone cohesive gels are solid and shaped anatomically,†says Teitelbaum, who keeps one on an office shelf. He’s sliced a wedge out of it so patients can witness its spill resistance for themselves. “You can’t pour them, and, if you rip the shell, the implants retain their teardrop shape.

Yet even the “gummy bear†is not without its critics. “The new cohesive gels have a harder and less natural feel, and they are more difficult to implant,†says s, who has not inserted the firmer implant since he is not involved in the clinical trials, but who has surgically removed them from a patient. “The traditional silicone gel is still the gold standard.â€

Longevity and shape retention are not the only nagging problems. Whether saline or silicone, implants—like all foreign objects inserted into the body—they may trigger infection and thick scar tissue. Sometimes tissue hardens around an implant, painfully squeezing and deforming the breast in a process doctors call “capsular contractureâ€.

“Of the estimated three million women in America who have implants, I suspect one third of them have messed-up breasts,†says Berman. “They have hard, distorted implants or leakage they don’t know about. And, he adds, “I don’t expect a lower rate of contraction with the cohesive-gel implants.â€

To counteract possible hardening, Berman recently came up with the idea of a “pocket protectorâ€, a pouch-like device that he uses to line the breasts with before he inserts implants. This internal brassiere is made out of a “Teflon spin-off called e-PTFE that has been used for years to graft arteries during heart surgeries (and less successfully, to created dental implants which, according to the FDA, have been associated with “severe bone loss†and “soft tissue degenerationâ€). Berman believes the material to be safe for breasts. He says d-PTFE prevents scar tissue formation because it has miniscule pores to which the body attaches fibers “somewhat like Velcroâ€. Over the past 30 months, he’s placed the patented “pocket protector†in 120 mammoplasty patients and eventually plans to submit the device for FDA approval.

“We haven’t seen the inflammatory reaction we used to see with the implants alone,†Berman says. “Now if a silicone implant leaks, it would be isolated in the ‘pocket protector’. I mean, you could get peanut butter and jelly in there and it would be walled off from the rest of the body,†he promises. Good luck finding women to participate in that trial!

Still, the suggestion that a patient needs a “pocket protector†to defend her body from her implants implies that the mammoplasty remains problematic. According to the FDA handbook, “breast implants may interfere with the detection of cancer by mammograms, and women with breast implants “may not be able to breast-feed.†Additionally, a 15-year study conducted by the National Cancer Institute involving 13,500 breast-augmentation patients concluded that women with silicone implants two times more likely to die from brain or respiratory cancers, and four times more likely to die from suicide than women who opted for other cosmetic surgeries. Meanwhile, a study published last year by a chemist at American University in Washington, D.C., found unprecedented levels of highly reactive platinum ( used to make silicone shells more pliable) in women with silicone implants and their children whom they had breast-fed; toxicologists say this heavy metal accumulation could potentially cause nervous-system disorders. And although plastic surgeons are urging the FDA to bring back silicone implants, some doctors in other specialties feel further research is needed.

“If one waits long enough…implants will eventually rupture or leak,†A. Choiti, an associate professor of surgery and oncology at Hopkins University School of Medicine who sits on the FDA advisory panel, wrote recently in a breast cancer newsletter. “My primary concern is that we have little information about the long-term effects of [silicone], which, if not fully removed, remains in the body permanently.

Of course, Choiti is not referring specifically to the new high-cohesive silicone-gel implants. But women who have charted the rise and fall of every new implant to come down the pike say it will take several decades of clinical data before the long-term safety of “gummy bears†is assured.

After 20 years, what happens to the microscopic particles of silicone that get through the envelope? Even firm silicone may break down and migrate,†says Sybil Niden Goldrich, director of the Command Trust Network, an implant information center in California. “Cohesive gels are the same thing we’ve seen before, only in a different dress.â€

The implant industry disagrees. “The cohesive gel does fit into the new and improved category,†says Dan Cohen, vice president of global, corporate and government affairs for Inamed, and implant manufacturer. “It’s demonstrably better.â€

Even if they are approved, high cohesives, just like saline and looser silicone-gel implants, come with only limited guarantees. Inamed’s warranty covers lifetime product replacement but provides $2,400 toward surgical labor for 10 years. The problem is that as long as implants are not permanent, breast augmentation patients will continue to represent lifetime annuities for plastic surgeons.

“It’s not like doing a nose job or an eyelid, when you might never see a patient again,†says s in Beverly Hills. “When you take on a breast patient, there’s a good chance that they are going to need another procedure.