Breast Implant Pain

Far too many women are experiencing breast implant pain and it is not acceptable.

When Kathryn Gordon’s black implant was sent for testing to Dr. Pierre Blais, Ph.D., a former senior scientific adviser at Canada’s version of the FDA, Health Canada’s Health Protection Branch, the results were unnerving.

“The implant was full of dead fungus–aspergillis [sic] niger, aspergillis [sic] fumigatis and a subtype of the albicans family–which could make the recipient very ill,” explains Blais, who has analyzed more than 7,000 breast implants. But he also found something far worse–dead, antibiotic-resistant bacteria: “Enough to fill a teaspoon.”

The bacteria and fungi were dead because the implant had been dunked in formaldehyde upon removal from Gordon’s chest, as is customary–so clearly this wasn’t mold that had grown afterward. “We’ve seen hundreds of cases like this,” maintains Blais. “But Ms. Gordon’s implant ranks number four among the most contaminated implants we’ve ever tested.”

In Blais’ analysis, small amounts of the bugs had leaked into Gordon’s body as her implant aged, making her feel sick. When the organism-filled sac was removed, antibiotics and antifungal drugs were able to wipe out the remaining germs in her body and restore her health.

“Had the implant stayed in longer, she might have been chronically ill; had it ruptured, her body could have been flooded with bacteria and fungus that drugs would have been unable to fight. She was really lucky to walk away from this,” notes Blais solemnly. “If I were her, I would not buy a lottery ticket for a long time.”

Mounting evidence suggests that in a small percentage of women, like Kathryn Gordon, implants become tainted with bacteria or fungus, which sometimes causes the sacs to discolor and, over time, the wearers develop autoimmune-like illnesses.

Although the FDA maintains that implants do not cause these illnesses, the agency is planning to review additional reports from the manufacturers’ ongoing studies (which will continue for about six more years). Mentor Corp.’s studies so far have already shown that 2 percent of augmentation patients and 9 percent of reconstruction subjects developed unspecified infections within three years.

Six women in each of the manufacturers’ studies were also deemed, using very strict criteria, to have autoimmune problems.

How could the implants become contaminated? When breast implants are shipped to a surgeon, they arrive deflated; in the office, the doctor fills them with saline solution through a valve.

If the conditions aren’t completely sterile–if, for example, the solution is exposed to air–germs could be introduced. Also, some doctors have been known to add ingredients like antibiotics and disinfectants in the hope of preventing infections.

These additives degrade in the implant’s solution after years inside the body. In fact, in Gordon’s implant, Blais did find degraded Keflin, an antibiotic, which contributed to the black color.

Worse, instead of protecting her it encouraged the growth of bacteria that were resistant to the drug, hence more dangerous.

Some experts believe that microbes can pass through the implant’s envelope and through imperfect valves. According to this theory, bugs could enter the sacs from the body, and/or germs growing inside could wind up on the device’s outer surface, infect the surrounding tissue and travel into the bloodstream.

The idea is controversial, however. “Cases of contamination have been cited in the past, but with today’s sterile techniques, bacteria or fungus should not enter the implant during filling or afterward,” contends Diane Hart, program manager of patient services at Mentor, the company that made Gordon’s implant.

Meanwhile, Blais, who has authored 250 scientific papers on the safety of implantable medical devices, believes women are still in danger. He has seen hundreds of black, brown and green implants–both saline and silicone-gel implants, which were banned for cosmetic use in 1992 but allowed for reconstruction patients–removed from women who had all types of health problems, including autoimmune symptoms.

These colors correlate to certain types of microbes present in the implant, he explains. “One of the most common contaminants in black implants is aspergillus niger, a black variety of fungus, while two other forms, aspergillus fumigatis and Bouffardi’s black, cause dark brown discoloration.” In the case of blue or green implants, the culprit is usually algae.

V. Leroy Young, M.D., professor of plastic surgery at Washington University in St. Louis, is another scientist who has shown that disease-causing microbes including E. coli, staph bacteria and aspergillus can grow in saline implants.

Further, a handful of studies have shown a connection between symptoms associated with autoimmune disease and germ-ridden implants of both the saline and silicone variety.

In one of these studies, Marek .K. Dobke, M.D., head of the division of plastic surgery at the University of California, San Diego School of Medicine, cultured both kinds of implants, removed from more than 300 hundred women complaining of muscle or joint pain, chronic fatigue, skin rashes, low grade fever, dry eyes and mouth, hair loss, and confusion or impaired memory.

He found bacteria (most commonly staph) or fungi in approximately 70 percent of cases–three times the rate of occurrence of bugs in implants removed from healthy women who were having an “explant” for cosmetic reasons (such as trading up a cup size).

He also found high rates of microbe contamination in women with capsular contracture and breast implant pain–a connection that many agree with, including Dr. Young, who fingers bacteria as the culprit.

“This strong correlation between microbes–mostly bacteria–and symptoms,” maintains Dr. Dobke, “may be the key to the health troubles so many women with implants have.”

Still, many experts discount such findings. Dr. Young, despite his own microbe studies, contends that the real discoloring culprits in most cases are the substances often added to the saline fill, such as Betadine, an antiseptic, which is brown.

He’s also suspect of research finding live germs in contaminated implants. “If the device has been sitting around in someone’s closet, you may find fungus, but that doesn’t mean it was there when the implant was removed,” he contends.

Others believe that implant patients’ autoimmune complaints are coincidental. “Women are genuinely suffering [from autoimmune problems],” explains James L. Baker Jr., M.D., clinical professor of plastic surgery at the University of South Florida in Tampa, “but women who have implants have the same rate of these diseases as those who don’t.”

Dr. Baker also points out that people who have other kinds of implantable devices in their bodies aren’t complaining of an autoimmune epidemic. But this is another point of debate. Small studies by Dr. Dobke and others have shown a link between painful symptoms in men and contaminated penile implants.

Blais adds that because implants are soft and fluid-filled, they may provide a more conducive environment for germs to grow than, say, a hard chin implant or knee replacement. However, he admits, a dearth of research on other types of devices leaves many questions unanswered.

“With many medical implantable devices,” he notes, “the patients are elderly, so autoimmune problems that take time to develop may not show up before a patient dies or may never be linked to the implant.”

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Comments on Breast Implant Pain Leave a Comment

June 21, 2011

Ben Kass @ 10:16 pm #

You might want to inform your subscribers of a new breast surgery recovery pillow. We are a new company and our product is the Side Sleeper Pillow. It allows a woman to recovery more comfortably and with less pain after any type of chest surgery for women. It will support her breasts and allow her to sleep comfortably and in her favorite position. This is the only successful product of its kind and was created specifically for this purpose.

June 23, 2011

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