Looking for Glamour Magazine Article from November

[Guest guest]

I am searching for the article that appeared in the November issue of

Glamour, entitled " Breast Implant Horror. "

I am hoping that someone has a copy of this article saved. If so, I

would really appreciate it if whoever has a copy of it would please send

it to me.

Thank you so much,

Lany

SBIPrayerForum

[Guest guest]

Here it is:

> BREAST IMPLANT HORROR>> LEAKY, SCARRING, BLACK WITH MOLD> WHY WOMEN ARE TAKING THEM OUT>> The shocking health claims against saline implants>> By Collier Cool>> [Glamour November 2000]>> Could saline implants-hardening, leaking, deflating and turning black with> fungus-be making women desperately ill? Former implant recipient > Gordon thinks so, and a growing number of doctors agree. Glamour> investigates.>> The squishy mound blackened with fungus in Gordon's fridge isn't a> lump of cheese gone bad. It's what the 33-year-old former actress from> Atlanta wore next to her heart, inside her bosom, for 11 years-a breast> implant she claims made her so desperately ill, she almost committed> suicide.>> In 1988, when Gordon was 21, she did what most of her friends had done;she> went to the doctor and got her bust enlarged from 34B to 34D. "I grew upin> a beach town where if you didn't have big breasts, you got them," she> explains. For the first seven years, she had no complaints. But then she> began to notice that her joints were slightly achy, she was more tiredthan> normal, and her hair was thinning-though none of the symptoms was bad> enough that she needed to see a doctor. It wasn't until she began> breastfeeding her newborn daughter in 1998 that her health really fell> apart, she remembers: "We both got an awful thrush infection that made my> daughter's mouth and my nipples bleed. After that, I was always exhausted,> despite sleeping 15 hours a day. I had hot and cold chills up my spine,> slurred speech and so much pain in my hands, I couldn't even open a jar of> baby food. It was like having a horrendous case of the flu all the time,">> Over the next nine months, Gordon says, she saw several doctors. "Eachtime> I'd outline my whole medical history, including my implant surgery," she> recalls. "They'd ask if I had silicone gel, and when I said, 'No, saline,'> they'd give me a big speech about how the body is made of salt water, soit> wouldn't matter if the implants had leaked or ruptured. They all felt my> implants couldn't be the problem-even though by then, I had severe breast> pain.">> In May of 1999, on the advice of a friend who knew someone whose implant> had ruptured in a car accident, she went to see Kolb, M.D., aplastic> surgeon in Atlanta. "I didn't even have to tell Dr. Kolb my symptoms-she> already knew what they were," recalls Gordon. "I started crying when she> asked questions like, 'Are you slurring your words?' and 'Do you feel like> someone is scratching inside your chest?' At last I'd found a doctor who> didn't think I was crazy and actually understood what I was goingthrough."> Dr. Kolb, who has saline implants herself, urged Gordon to have hers> removed immediately.>> "When I opened her up, her breast tissue was very inflamed, and the> implants looked black," recalls Dr. Kolb. "It was the third time I'd seen> black implants in the 100 saline [implant] removals I've done. I believe> the implants were darkened by a fungus, which then migrated into 's> bloodstream to cause the symptoms she was experiencing." Six weeks after> Dr. Kolb removed Gordon's implants and treated her with antibiotics and> antifungal drugs, Gordon felt fine.>> SAFETY DEBATE>> Last year, more than 167,000 American women chose to have their cup size> upped with saline implants, paying an average of $3,000 per pair. Breast> augmentation continues to be the second-most popular cosmetic procedure> (after liposuction) for women in this country, according to The American> Society of Plastic Surgeons (ASPS). So clearly the vast majority of> customers are happy with their implants. Indeed, a recent University of> Minnesota study of 450 women who had saline implants put in 10 or more> years ago found that 93 percent of them were "satisfied" or "very> satisfied" with their surgery results-and nearly 96 percent said they'd do> it all over again.>> But new data just released by the very companies that manufacture saline> implants show that their products have a surprisingly high rate offailure.> These findings may explain why 43,600 women had their implants (bothsaline> and silicone) removed in 1998, according to the ASPS- a 41 percent rise> over removal figures for 1992-and why among those women, 17 percent of the> augmentation patients and 26 percent of cancer victims who had chosen> reconstruction opted not to get them replaced.>> To investigate the real price of bigger breasts, Glamour spoke to experts> on both sides of the saline implant safety debate, including 13 women with> symptoms similar to Gordon's. Most of their symptoms cleared up as> soon as they had their implants taken out. None of these patients is suing> her implant manufacturer (although some other women are), but they shared> their stories in hopes of alerting others that when it comes to getting a> "boob job," the decision should not be taken lightly.>> [Picture of Gordon's reflection [head and shoulders] looking back> from mirror; caption: Tests showed that Gordon's implant was full> of fungus and contained an entire teaspoon of bacteria.]>> [Full-page picture of Gordon's cupped hands holding a blackened> saline implant; caption: Could breast implants make you sick?]>> FAULTY DEVICES>> Although saline implants have been on the market since the 1960s and now> generate roughly $800 million a year for manufacturers and plastic> surgeons, the Food and Drug Administration (FDA) did not evaluate them for> approval until this year. The initial lack of scrutiny was due to the fact> that the implants slipped into the marketplace before the FDA sanction was> required for medical devices. However, prompted by nearly 50,000 reports> from women and doctors about adverse side effects-including 118> deaths-allegedly related to implants since 1985, the agency finally did> order two major U.S. breast implant manufacturers, McGhan Medical and> Mentor Corp., to conduct ongoing studies that would establish the safetyof> their products. Findings from the first three years of the trials and some> of the fourth-year data were released at FDA hearings last March. The> results surprised many and caused some women's health advocates to caution> strongly saline implants.>> The McGhan study of 1,169 women with its brand of implants found that 60> percent of those who had their breasts enlarged and 84 percent who> underwent reconstruction for medical reasons suffered at least one> complication within four years. The researchers uncovered a wide array of> problems. More than one fourth of cosmetic patients ended up with> asymmetrical, wrinkled or scarred breasts, while 8 percent had improperly> positioned implants and 17 percent had either intense nipple sensation or> numbness. Sixteen percent suffered moderate to very severe breast pain; 9> percent developed capsular contracture, an often painful hardening of> tissue around the implants that, in severe cases, causes disfigurement;and> another 9 percent had implants that could be felt or seen through their> skin.>> Cancer survivors and other reconstruction patients fared far worse:Almost> three-quarters had scarring complications, folds, asymmetry or implant> positioning problems; 20 percent had visible or palpable implants; and 15> percent were in moderate to very severe pain. In addition, about one in 20> women in both groups had an implant that leaked or deflated within three> years. The studies conducted by the Mentor Corp. showed similar results.>> "This is shocking data," charges Norman , M.D., former chair ofthe> FDA's medical devices committee from 1984 to 1988 and currently associate> professor of medicine at s Hopkins School of Medicine in Baltimore.> implored the agency to put a stop to saline implants, testifying> that they "have the potential to have the highest failure rate of any> device ever approved by the FDA." Despite his pleas (there were 19> speakers, representing both individuals and groups, who testified in> support of saline implants; 18 testified against them), they were approved> in May. "It's a horrible situation," he told Glamour. "These devices can> deflate if they get a crack the size of a pinhole. I have patients in my> practice who have had as many as 14 implant operations.">> The FDA, however, stands by its decision to approve saline implants. "The> vast majority of complications don't affect health but rather the quality> of the cosmetic results-such as a lack of symmetry, wrinkling or capsular> contracture," contends al, M.D., director of the FDA's Centerfor> Devices and Radiological Health. "As with many cosmetic procedures, it's> not unusual to have additional surgery." The implant makers, for their> part, maintain that such risks are a small price to pay for the benefitsof> bigger breasts, all things considered. "The FDA panel voted our product as> a safe and effective device that satisfies medical and psychological> needs," asserts Ilan Reich, president of Inamed Corp., the parent company> of McGhan. "All of our studies show that implants make women feel better> about themselves and vastly improve the lives of cancer patients who have> had mastectomies.">> [Two pictures: Gordon [clothed], post implants (right); a pair of> saline sacs [look like white hockey pucks] prior to insertion (left);> caption: One fourth of breast augmentation patients end up with> asymmetrical, wrinkled or scarred breasts.]>> Yet Cherien Dabis, 24, believes that no amount of bust-boosting confidence> is worth the pain her implant caused her. In 1996, the Silver Spring,> land, publicist had her left breast, which failed to develop due to a> birth defect, reconstructed. First, her saline implant shifted upward,> making it noticeably higher than her other breast. Soon after that, she> developed chronic breast pain. By January of this year, her breast had> become painfully hard, a fairly common complication of saline implants, as> shown by the manufacturers' studies. All of this might have been bearable,> but then in June, she says, for no apparent reason her implant ruptured."I> stepped out of the shower and noticed my left breast was gone," she> recalls. "It was completely flat. I kept staring at myself in the mirror> because I couldn't believe this had really happened.">> Dabis had to have the implant removed. "What was left of it looked really> ugly, like a deflated balloon covered with dark purple, mucuslike slime,"> she says. "I decided not to have it replaced.">> REPEAT SURGERIES>> One unsettling finding to emerge from the FDA hearings is how often breast> jobs have to be redone. The McGhan study showed that more than one out of> five women with cosmetically enhanced busts-and 39 percent of cancer> patients-need additional surgery within three years. The top reasons for> such procedures include replacement of ruptured and leaking implants and> alleviation of hardened breasts caused by capsular contracture and other> factors. And new implants don't always solve the problem. After a second> surgery, nearly half of cancer patients (whose remaining breast tissue and> immune systems may be more fragile due to surgery, radiation and> chemotherapy) develop severe capsular contracture, and 26 percent requirea> third set within two years.>> Kim Green, a 36-year-old homemaker with two children in West Hartford,> Connecticut, got breast cancer in 1998, when she was seven monthspregnant,> and had her breasts rebuilt after a double mastectomy. So far, she has> endured 11 operations, at a cost of more than $70,000 (all of it coveredby> insurance). And with only one implant right now, she faces still more> surgery this coming January for the second. Each time implants have been> removed, she says, "it's like having a mastectomy all over again, with> total anesthesia and drains in my chest. It's been devastating-I spent a> whole year having surgery almost every month. When I was diagnosed with> breast cancer-which killed my mother when she was 35-I just wanted tolive.> I never dreamed reconstruction could be this bad. It's worse than> chemotherapy." Yet she's determined to keep trying. Getting her "breasts"> back is somehow a symbol that she's gotten past her disease. "I want to> look as normal as possible," she confesses.>> Despite stories like this and the complication rates shown in the latest> studies, FDA officials feel it's ultimately up to consumers to decide what> risks they will take. Thanks to the hearings, both implant companies now> have new package inserts that detail the study findings, which are also> posted on the FDA Web site at www.fda.gov. "Patients can [now] look at the> brochures to find out about the experiences of women who have these> implants," says the FDA's Dr. al. "The whole purpose of the FDA> approval process was to gather information so patients know exactly whatto> expect.">> THE EXCRUCIATING PAIN>> When Gordon's black implant was sent for testing to Dr. Pierre> Blais, Ph.D., a former senior scientific adviser at Canada's version ofthe> 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'sbody> as her implant aged, making her feel sick. When the organism-filled sacwas> removed, antibiotics and antifungal drugs were able to wipe out the> remaining germs in her body and restore her health. "Had the implantstayed> in longer, she might have been chronically ill; had it ruptured, her body> could have been flooded with bacteria and fungus that drugs would havebeen> 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 longtime.">> Mounting evidence suggests that in a small percentage of women, like> 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 doctorfills> 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 typesof> 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 WashingtonUniversity> 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 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 L. Baker Jr., M.D., clinical professor of plastic surgeryat> the University of South Florida in Tampa, "but women who have implantshave> 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 theirbodies> 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 medicalimplantable> 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.">> A PERSONAL DECISION>> Not all scientists who believe that implants trigger autoimmune disorders> finger microbes as the culprits. Many, despite substantial scientific> evidence showing otherwise, steadfastly claim that silicone is to blame.> "Many women don't realize that saline implants are surrounded by asilicone> shell, just like the one that surrounds silicone-gel implants," points out> Vasey, M.D., chief of rheumatology at the University of SouthFlorida.>> A more tangible area of concern, acknowledged by almost everyone in the> medical community: Implants may make it harder to detect breast cancer.> One reason is that cancer cells can be confused with calcifications around> the implant on a mammogram. Also, the sizeable sacs may obscure lumps one> would normally notice in a self-exam. "This is very scary," charges > Zuckerman, Ph.D., president of the National Center for Policy Research for> Women and Families in Washington, D.C., "because cancer may be missed or> diagnosis delayed until the disease reaches a later stage, when it's less> curable.">> Women need to push their doctors to be up-front about the risks, cautions> Zuckerman, because some may downplay any bad news that could deflate their> profits. And the FDA approval should not put you at ease, she warns: "To> call saline implants safe on the basis of three- or four-year studies paid> for by implant manufacturers leaves women dangerously in the dark." That's> why if you're considering surgery, it's crucial to check the FDA Web site> (www.fda.gov) to learn about possible side effects and discuss them in> depth with your surgeon. "Getting implants is a lifelong decision, because> even if you later have them removed, your breasts will never look as good> as they did before the operation," she stresses.>> Ultimately, says Dr. Kolb, the Atlanta plastic surgeon who removed > Gordon's implants, it's up to women to make up their own minds-aconclusion> shared by most medical professionals. Despite falling ill herself with> unshakable fatigue, dizziness, muscle aches, numbness in her arms, dryeyes> and memory problems after getting silicon[sic]-gel implants, Dr. Kolb> continues to augment other women's breasts, with saline, and now is> delighted with the salt-water pair she wears herself. "How can I betotally> against something I have in my own body? I agree there's vast room for> improvement, but as long as women are fully informed of the risks. Why> can't they decide for themselves, as I did?"> -ADDITIONAL REPORTING BY DINA ROTH>>> Saline Sound Off!>> Here, two experts duke it out over saline implant safety.>> THE PROS> LORI SALTZ, M.D., is a plastic> surgeon in La Jolla, California,> who has had silicone implants for> 24 years and believes silicone and> saline implants are safe.>>> THE CONS> ILENA ROSENTHAL is director of> the Humantics Foundation for> Women, Breast Implant: Recovery> and Discovery in San Diego.>> ON THE DANGERS OF INFECTION/ DEFLATION: SALTZ> While there is a risk of infection in any elective surgery, I only fill> implants with sterile saline through a closed system-from the IV bag> through a sterile tube into the implant. If an implant deflates, your body> will absorb the solution, which is the same as what's in an IV bag at the> hospital.>> ON THE DANGERS OF INFECTION/ DEFLATION: ROSENTHAL> The labels on 1-liter bottles of saline IV solution recommend storage at77> degrees and include a discard date of about 18 months. With implants, the> saline is stored in your body at 98.6 degrees for years, which, I believe,> makes it a very good medium for fungi and other microbes to grow. I've run> across a lot of women who have saline implants and symptoms of subclinical> infections.>> ON THE CONNECTION BETWEEN IMPLANTS AND AUTOIMMUNE DISORDERS: SALTZ> There's no proof to justify pinning the autoimmune complaints on implants.> A million other things could be causing these symptoms. I haven't seen> these problems in my practice.>> ON THE CONNECTION BETWEEN IMPLANTS AND AUTOIMMUNE DISORDERS: ROSENTHAL> I think the saline implant's silicone shell could cause systematic (sic)> [read: "systemic"]reactions in some cases. Women with saline implants> complain about the same autoimmune problems that those with silicone-gel> sacs did.>> BOTTOM LINE: SALTZ> I'm not saying everyone with breast implants is going to be happy. I see> some women whose scar capsule around their implants contracts and hardens> when we put them in. But it should be a woman's choice, not the> government's decision.>>> BOTTOM LINE: ROSENTHAL> I've seen thousands of women who got implants suffering healthwise. I just> want anyone thinking about enhancing her breasts to realize that the risks> are very real and serious, and that the complication rate is> extraordinarily high.>> -EILENE ZIMMERMAN>>