Are Moldy Breast Implants a Cause For Concern?

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Are Moldy Breast Implants a Cause For Concern? featured image

Anne Ziegenhorn of Shalimar, FL, made headlines at the end of last year when her goose bump–inducing story of finding out she had moldy breast implants hit.

Since then, Ziegenhorn has been a staunch advocate of “educating others through our experiences on the dangers of breast implants and changing federal policy to protect women’s health” via The Implant Truth Survivors Committee, an organization she founded that’s also going head-to-head with the FDA. Now, she is making news again. Next up: A national spot on The Animal Planet show “Monsters Inside Me.”

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While this is an unfortunate story, Las Vegas plastic surgeon Michael Edwards, MD, says in no way or form does it represent the majority of women who are very happy with their implants. “I have been a plastic surgeon for more than twenty years and I have cared for thousands of women with implants. I have never removed implants where there was an infection or contamination with mold. The only way this would conceivably occur would be if there was a contamination of the saline fill material.”

Pepper Pike, OH, plastic surgeon Lu-Jean Feng, MD, says that, in her 28 years of experience removing breast implants, she also has rarely encountered mold. “To be specific, I have only encountered two such cases out of thousands, containing mold, as confirmed through pathology findings and culture results. This type of contamination can only happen at the time of insertion of the implants. After viewing the video on moldy implants it is evident that the footage was not captured intraoperatively at the time of removal from the body. The person holding the discolored saline implant is not wearing sterile gloves so it is misleading how long the implant has been removed from the body. Mold can form on the surface of the implants after removal and storage for a period of time.”

Dr. Feng does say, however, that she does not doubt Ziegenhorn became very ill from having breast implants. “I personally have seen thousands of patients who have also had an inflammatory reaction and developed similar health problems. As part of my standard protocol, all implants are photographed in the operating room at the time of removal. They are then sent to an outside independent pathology firm to be thoroughly and carefully evaluated. Dark patches and spots on or inside the implants is typically acellular debris from blood. The only possible way mold could get inside an implant would be if it was introduced at the time of insertion. It would be highly unlikely if the implants were put in by a board certified plastic surgeon in a sterile operating room. Furthermore, from a medical standpoint, the only way to detect mold is through pathology of the scar capsule and a culture of the implant content. Mold cannot be detected by visual inspection and therefore, assumptions should not be made that any discolored or dark areas on an implant represent mold.”

“I suppose that it is possible that the saline inside implants could be contaminated if exposed to the air by being decanted into a sterile basin, but that’s rare, given the use of closed saline implant fill systems,” adds Eugene, OR, plastic surgeon Mark Jewell, MD, who stresses that the topic of implant-related disease has pretty much been refuted with high-level studies in the New England Journal of Medicine. “Plus, with the return of gel to the market in 2006, the use of saline is not very common these days.”

That’s the year the FDA approved silicone breast implants, and, according to Dr. Edwards, this approval came only after 14 years of study with thousands of women who had implants placed for reconstruction as well as for aesthetic surgery.

“We as board-certified plastic surgeons have learned much in our quest to care for our patients in the safest manner possible yielding results patients are pleased with. It is estimated that there are over five million women—by conservative estimates—that have breast implants and statistics show the overwhelming majority of women are satisfied with their results,” Dr. Edwards adds.

And it’s this satisfaction that makes breast implants one of the most popular surgical procedures—and one of the safest. “No other medical device has been studied as much as breast implants,” La Jolla, CA, plastic surgeon Robert Singer, MD, says. “The majority of patients are very pleased and would do it again.”

But one very important thing anyone considering implants should know: They are not meant to be lifetime devices. Plus, as Dr. Singer adds, no one can guarantee the life cycle of them but has yet to see a case of mold in an implant. “It could happen, but it would be very, very unlikely with the methods used now to fill saline implants. Infections and problems can happen with any surgical procedure but, statistically, the rate is low.”

So what about those problems that you do read about? “In every patient who I have ever cared for who had a saline implant deflation, their body reabsorbed the sterile saline and they benefitted from a surgery to replace their implants,” Dr. Edwards says. Adds Dr. Feng, “Many women develop health problems associated with their breast implants as evidenced by certain commonly occurring symptoms—but, in all of the thousands of implants I have removed and photographed and sent to pathology, I have never seen any that look like the one shown in this video.”

Any patient who feels they have a problem possibly related to their breast implants should schedule a consultation with a board-certified plastic surgeon who can evaluate them and make suggestions for proper care. This care may involve removing the implants or removing and replacing them.

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