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Silicone implants are back, but little reason to fear
Silicone breast implants are now available for cosmetic purposes after a long hiatus, and chances are good that surgeons are using them in your operating rooms. But should you worry about a repeat of the lawsuit frenzy that led to the banishment of silicone implants years ago?
There is some need for caution, but not much reason to worry, says Al Bixler, JD, an attorney with the law firm of Eckert Seamans in Philadelphia. Bixler is experienced with defending medical malpractice cases and has studied the history of silicone implants and related lawsuits. A wave of lawsuits and intense media criticism in the 1990s led to the 14-year ban.
"The question everyone is asking is, 'Will that happen again?'" he says. "The answer is that it is very unlikely to be like what we say in the '90s. But that doesn't mean there won't be lawsuits."
Until the approval earlier this year, silicone implants were available in the United States only to women seeking breast reconstruction and revision surgery through clinical studies. After rigorous scientific review, the Food and Drug Administration (FDA) approved the marketing of silicone gel-filled breast implants made by two companies for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older. The products are manufactured by Allergan Corp. (formerly Inamed Corp.) of Irvine, CA, and Mentor Corp. of Santa Barbara, CA.
There still may be suits
As risk managers know, patients don't necessarily have to have a good case or a true injury in order to sue. So Bixler says it is possible that some patients will make unfounded claims related to silicone implants just because of the past controversy. Even with the lawsuits of the 1990s, there was little or no scientific basis for the claims of patient injury, Bixler says. Instead, the claims were the result of hysteria hyped by the media, he says.
If a patient sues after receiving silicone implants, the hospital or surgery center probably would be named as a defendant also, Bixler says. The difference this time around, unlike the 1990s, is that there is a wealth of scientific evidence showing the safety of the implants, he says.
"Even though the FDA has now approved silicone implants and even though the science behind the previous claims has been largely debunked, those two facts alone will not immunize a surgeon from potential claims," Bixler says. "You can see examples all the time of FDA-approved devices and pharmaceuticals that give rise to litigation."
More evidence to show safety
The FDA approved the wide use of silicone implants only after extensive clinical studies proved their safety, so Bixler says any health care provider would have a solid defense against claims that the implants themselves are unsafe.
"I don't see the plaintiff's bar being eager to take on a difficult case where the science is against them, because they are in business to make money like the rest of us, and that is just not good business sense," he says.
To reduce the chance of nuisance cases from patients who remember the previous lawsuit frenzy, Bixler suggests taking steps to makes sure that patients are well educated about not only the current scientific data regarding the safety of silicone implants, but also their controversial history. The informed consent process should include some discussion of how silicone implants were the subject of numerous lawsuits alleging patient harm, and the FDA's decision to restrict their use for many years, he says.
"You can't expect the patient to evaluate the epidemiology and the long scientific history, but you can be certain that the patient is aware of the history of this device," he says. "Full disclosure is always best in the informed consent process. You don't want someone claiming that she had no idea silicone implants were once criticized so harshly."
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