Sunday, September 9, 2007

Silicone Breast Implants

A controversial procedure returns to market, deemed safe but still doubtful.

After a 14-year ban, silicone implants were re-approved in November 2006.

The ban came from the FDA’s reaction to the public concern that implants were responsible for women’s health issues including cancer, immunological diseases and rheumatoid arthritis. When manufacturer Dow Corning was unable to prove that the implants were completely safe, they were bankrupted by over $3 billion in lawsuits.

Silicone implants had, to that point, been favored over saline implants because they felt softer (saline implants were known to be unnaturally hard) and were less likely to spontaneously deflate.

Fourteen years of research revealed no link between implants and the serious health issues cited.

The FDA therefore decided to leave the decision to the discretion of women and their surgeons. But recovering the reputation of silicone (or gel) implants is an uphill battle, and critics still question why the FDA would rush re-approval when longer-term testing might expose risks. A month after the ban was lifted, an Austrian study rekindled the old concerns.

“Fourteen years isn’t much of a rush,” counters Dr. Paul Petty, consultant to Mayo Clinic’s department of plastic surgery. “There have been a number of very large studies conducted by epidemiologists—not plastic surgeons—looking for any kind of correlation between implants and significant disease entities, and none has ever been found. And there were many hundreds of thousands of ‘patient years’ to look at during the time that those evaluations were being done.”

Lifting the ban hasn’t made things easier on anyone.

Consumer advocates may suspect that the ban was lifted to benefit implant manufacturers and/or a lobby of plastic surgeons. But the lift comes accompanied by FDA restrictions that hogtie manufacturers, doctors and even patients.

Exasperated by the restrictions, Petty says, “It’s a way for the government to say yes and no at the same time, and the way they’re saying yes is so onerous that most [plastic surgeons] don’t want to put the implants in anyway. All of the patients who are getting implants are still on a 10-year FDA study with obtuse requirements, and there are many strings attached for the doctors and the manufacturer.”

The two biggest corporations dedicated to keeping breasts plump and faces firm are Allergan (the Botox people) and Mentor. Both make silicone and saline implants.

No implants are without risks or possible complications.

Among the most common is capsular contracture, the uncomfortable tightening that results from scar tissue build-up around an implant.

Another is when small amounts of silicone gel leak from a ruptured implant or bleed through its porous lining.

“A mammogram can easily identify a little piece of free gel with scar tissue around it,” says Petty, describing what is known as a siliconoma. The name is frightening, but Petty explains that they are innocuous.

“Siliconomas form a palpable lump, but there’s not a health risk associated with them. If they’re not in an obvious location [i.e., visible on the breast surface], you can just leave them alone.”

Connective tissue diseases (CTD’s) were among the biggest concerns leading to the ban, since many women with silicone implants were found to have CTD. It’s been found, however, that CTD is as common in women without implants, and the connection was never proven or disproven. The FDA has developed a document outlining potential complications.

Cosmetic silicone implants are approved for women aged 22 and older.

The minimum age for saline, in contrast, is 18. Why the difference? The FDA’s age specification is a bit random but one justification is that, in their words, “A young woman may not be mature enough to make an informed decision about the potential risks.”

What’s more, the 22-year-old may be more likely to follow the FDA’s recommendation for bi-annual MRI exams to test for leakage—though she’d have to be a wealthy twenty-something to afford the procedure, which costs thousands of dollars and is rarely covered by insurance. Another thought is that a more mature woman may stand a better chance of understanding the voluminous documents she’ll be asked to read in advance of surgery.

(Note: There is no minimum age for breast reconstruction based on damaged tissue, as for cancer patients or young women with breast abnormalities.)

Implants don’t last forever.

Petty tells patients with silicone implants that they stand a 20 percent chance of needing a second surgery within 10 years to correct capsular contracture. Patients with saline implants run the same odds of a second surgery within 10 years due to either capsular contracture or rupture. And, Petty says, there’s a 100 percent chance that the “fancy water balloon” will need to be removed or replaced within 30 years. One way or another, nature will eventually have its way.

1 comment:

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