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Information for Transformation

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Breast Implants

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Scar tissue around ruptured implant
Capsular Contraction
Pulling Silicone from ruptured implant
Scar tissue around ruptured breast implant
Capsular contraction of breast implant
Pulling silicone from ruptured breast implant
Silicone Induced Necrosis of breast tissue
New Breast Implant
Ruptured Silicone Implant

Silicone Induced Necrosis

"Trust Me Dear, These implants will last a lifetime"

Ruptured Silicone Implant

Silicone implant disease (also called human adjuvant disease or silicone-induced illness) is a new illness category developed by physicians now treating women with implants. There has been a great deal of controversy regarding the safety of silicone breast implants. For the women who have implants, conflicting media reports can be a source of considerable stress. There are still many unanswered questions regarding the safety of silicone breast implants. Studies are ongoing, but results may not be available for several years. Education may help relieve some of the anxieties until results become available. Breast implant manufacturers knew of multiple risks associated with implants, and responded by terminating studies, sponsoring only research they could control, and by misrepresenting the risks to the users, physicians, and regulatory agencies.

Silicone had been successfully used for many years in a host of medical devices, with virtually no bad publicity regarding biological or autoimmune incompatibility. So the medical establishment embraced the practice of placing foreign silicone objects into women's bodies before those objects were rigorously tested for safety. Before the disclosures of industry and the media forced the issue to a head, patients assumed that silicone-gel implants had long ago been deemed safe. It was revealed that few plastic surgeons reviewed possible systemic risks in any significant detail and unless specifically requested, they had not provided patients with the package inserts that came with the implants. While many women believed that what was being implanted into their bodies had been given the FDA's approval, in truth the implants had slipped through a strange regulatory loophole. As of January 1982, however, silicone implants had been only preliminarily (not officially) placed in Class III by the FDA--which meant the devices would be evaluated and regulated to assure safety and effectiveness--given that the FDA believed the devices posed "a potentially unreasonable risk of injury." Safety data from manufacturers--due to the 1976 grandfather statute--did not require research findings to be submitted for FDA review.

The Food and Drug Administration is not comprised of scientists who sit in labs testing experimental drugs and medical devices. The agency does no testing of its own; mostly it reviews existing data or creates panels of experts who examine other studies, interpret their validity, translate the findings, and make judgments about whether a product is safe for use by the public. This lack of direct involvement in the research end of product analysis is one reason why the approval process for new drugs and medical devices in the United States takes many years. In the case of silicone gel, the FDA relied to a great extent on test results submitted by manufacturers and was thus at the mercy of these tests' validity. Such evidence frequently takes many months or years to be gathered and provided to the FDA, thus limiting the agency's ability to provide timely protection of the public against an unsafe product.

Regulation of drugs in the United States became much tougher in the early 1960s after the travesty of thalidomide, a drug taken by pregnant women which caused severe birth defects. However, while medical devices were meant to be more strictly regulated, along with drugs--they are to this day evaluated separately and with a different set of rules by the FDA--devices were stricken from teh new regulation bill passed in 1962. This quirk occurred just in time to render the FDA powerless to make judgments about the new silicone-gel breast implants. It was not until 14 years later, in 1976, that the FDA was granted the authority to regulate medical devices. However, this change in policy applied only to new devices. Breast implants, which had been in use for years in hundreds of thousands of women, were "grandfathered" by the FDA; that is, their safety was assumed because they had been used on an ongoing basis for years without demonstration of health risk. Safety data was asked for by the FDA; however, manufactureres were given many years to get together such information. Essentially, this grandfather designation by the FDA was a lack of disapproval for silicone implants rather than a genuine approval of safety.

In 1978, FDA scientists recommended that breast implants be put in a category that would require proof of their safety. For some reason, however, an early panel formed to evaluate the issue didn't require such proof at that time. The FDA moved toward the reclassification of implants again in 1982, this time placing them preliminarily into Class III, meaning that they were deemed to pose "a potentially unreasonable risk of injury." But due to the grandfather statute, safety data wouldn't be submitted for agency review for nearly a decade. The silicone implant safety studies thus slipped through one hole in the regulatory net after another.

In 1984, the FDA began the Medical Device Reporting (MDR) Program, which required manufacturers to report to the FDA all failures of devices noted by surgeons. However, the information gathered was not directly disseminated to patients via product literature, and so a critical link in the communication chain broke down. It was not until the following year that Dow Corning (the largest of the implant manufacturers until dropping out of the estimated $500-million-a-year marketplace in 1992) began noting the risk of "immunological problems" on their package inserts. And as recently as 1991, near the end of Dow's brochure, bothered to address autoimmune disease at all. Not surprisingly, after the implant controversy began to escalate, Dow Corning began running an "educational" advertising series, inviting concerned patients to call a hotline for the "facts" on implant safety.

On December 30, 1991, the FDA sent a warning letter to Dow Corning stating that some of the information provided to women over the company's toll-free information line was "false or was used in a confusing or misleading context." The FDA cited "verbal statements made by Dow Corning's hotline staff that overstated the safety of their implants or minimized known or suspected side effects." The FDA documented these false or misleading statements, including assertions that breast implants are 100% safe, and that the FDA advisory panel (which met on November 12-14, 1991) said that breast implants were safe, that silicone cannot migrate to other organs in the body, and that breast implants have never been linked to autoimmune or connective tissue diseases." Finally, the memo stated that "the FDA believes that Dow Corning's hotline is falsely reassuring women of the safety of breast implants when studies have not fully shown the frequency of known adverse effects, nor whether potential long-term effects such as autoimmune disease can be linked to the implants."

History

The first women believed to have their breasts enlarged with silicone were Japanese, possibly in the mid- to late 1940s. In these cases, liquid silicone gel, as well as paraffin and other substances, were injected by syringe directly into the breasts. Many of these women were prostitutes who had discovered that American servicemen preferred women with larger busts than were common in Japanese women. Concern about their health was apparently a very low priority. Beginning in the 1950s, physicians in the United States began using injections of liquid silicone as well, in addition to implanting sponges directly into women's breasts. The practice was continued for years. According to a report in the American Journal of Nursing, it was finally banned by the FDA due to a wide range of "disastrous" complications, in most, if not all cases, including infections from improperly sterilized silicone materials and patient injuries and deaths. All other silicone injection procedures used by plastic surgeons and dermatologists for alterations such as lip enhancement and the smoothing of facial wrinkles have also since been completely halted by the FDA.

The search for an alternative way to introduce silicone into the female breast for the purpose of physical enhancement led to a major change in 1961. That year, Drs. Thomas Cronin and Frank Gerow, who later joined implant manufacturer Dow Corning, first combined rubbery and liquid silicone to create a soft but firm gel. They enclosed the gel in a silicone-rubber envelope. In 1962, Dow Corning Corp., a joint venture of the Dow Chemical Co. and Corning, Inc., introduced the first silicone breast implant in a Houston woman, and the era of surgical breast enhancement began.

The liquid based silicone gel implant was intended to remedy the problems caused by direct injections of silicone. These implants, promoted as being fit to last a lifetime, were constructed of a rubberized silicone shell surrounding a silicone gel which, in finished form, is 80 to 85 percent liquid silicone. By the late 1960s, silicone manufacturers were aware that this silicone gel would bleed out of the implants and migrate throughout the body. Indeed, in 1965, one Dow Corning scientist wrote "we know that something is getting out of the bag . . . ." And by 1980, the manufacturers were aware that silicone gel would pass through breast milk. The manufacturers never informed the public of these or other findings that raised further serious questions about the safety of implants.

The chemical makeup of silicone gel implants was virtually identical to the chemical makeup of liquid silicone that was injected into the breasts of women. The known complications associated with liquid silicone injections included atypical immune diseases that the researchers at the time termed "human adjuvant disease." Silicone gel implants did not remedy the problems caused by direct injections, and even caused other equally serious problems. The shell was fragile; it permitted the silicone to leak out of the implant and into the women¹s bodies and rupture under normal use. The gel, largely made up of fluid, escaped from the shell and moved throughout the woman's body.

Dow Corning was not alone in its discoveries. By the 1970s, all of the manufacturers had become aware of a growing leakage and rupture problem. Indeed, as plastic surgeons began to see complications in their patients--complications that appeared remarkably similar to those seen with liquid silicone injections--they expressed their alarm to the manufacturers. Notwithstanding these complaints, the manufacturers assured the plastic surgery community that its concerns were unwarranted. They repeatedly restated their position that silicone was biologically inert and was safe for use, despite having no long-term studies to support this claim.

Shockingly, while making those representations, the leading manufacturer, Dow Corning, was engaged in a secret program, in conjunction with its parent Dow Chemical Co., to utilize liquid silicone as pharmaceutical drugs, vaccines, and insecticides. Indeed, in the late 1960s and early 1970s, Dow Corning conducted a series of research studies that concluded that silicone does stimulate the immune system. This is in contrast to the position they now assert that liquid silicone from their implants does not stimulate the immune system. At the same time, Dow Corning and Dow Chemical, to whom the other manufacturers looked for leadership, were also investigating the use of liquid silicone as insecticides, fungicides, and herbicides. The same liquid silicone found in breast implants succeeded in killing cockroaches.

The public, and specifically the women who were being induced to purchase implants, were never told of these studies, nor the potentially toxic properties of the silicone. The manufacturers did not maintain any registries of implanted women so that their health and complication rates could be tracked over the years. Such registries are common among manufacturers of potentially hazardous products. Michelin Tire Co. and Chrysler could not accomplish a meaningful product recall without maintaining such registries. Surely, a manufacturer of an implantable medical device should be held to a standard at least as rigorous as that of an automotive manufacturer or a software development company. Even though the manufacturers put implants on the market without any long term testing of their safety, the manufacturers had ample evidence of local complications long associated with implants -- evidence they chose to ignore.

By the time FDA commissioner David Kessler decided in 1992 to ban silicone-gel-filled breast implants, an estimated 1 million to 2 million American women already had them. (The precise number is unknown.) According to Kessler, the manufacturers had not fulfilled their responsibility to demonstrate the safety of the implants, and he therefore had no choice but to take them off the market. Thus ended 30 years of the easy availability of breast implants (for those who could afford the surgery). Most women with implants had simply wanted to enlarge their breasts, but about 20 percent had obtained them for reconstruction after mastectomy for breast cancer. Eventually, the breast implant manufacturers, losing one product liability case after another, agreed to the largest class-action settlement in the annals of American law.

Leakage

Implant manufacturers have maintained for many years that silicone implants are safe and inert. Yet simply placing an implant on a paper napkin will produce an observable absorption of gel on the paper within hours. While this "bleeding" effect does not, in itself, prove toxicity, it certainly raises reasonable doubts about silicone safely remaining within the implant. This "bleeding," moreover, occurs in all implant recipients, and is the first--and fastest--means by which the body can be exposed to silicone. Because the gel and the outer envelope are both made from the same material--elemental silicon and oxygen--it is possible for the gel to slip through the microscopic pores in the outer envelope due to pressure (from wearing a bra or carrying a grocery bag against the chest, for example) or even due to the simple force of gravity over time.

Then, of course, there is the risk of leakage due to rupture, which is virtually equivalent (physiologically) to gel injection. This can occur regardless of whether the implant is placed directly under the breast tissue (between the mammary glands and the chest muscle) or under the chest muscle against the chest wall. Many factors have been shown to cause rupture--from a cut during a breast biopsy, to the suckling or bite of an infant, to the pressure exerted by a shoulder strap during an automobile accident. Highly active women who ski or windsurf may also put too much stress on their implants, causing the seams to burst open and gel to leak into the body. Wherever the silicone goes, scarring, swelling, and inflammation may occur.

The shell for both gel- and saline-filled implants is made of the same silicone material. Since congregations of macrophages (the cells which ingest, kill, and digest foreign substances in the body), are found on the surface of silicone implant jackets after explantation, it appears that these immune-system cells attack the jacket itself--whether or not silicone is leaking from it. This process can be likened to gophers chewing into and through the implant's wall, chiseling off microscopic pieces of silicone, which then lodge in neighboring body tissue. Eventually, this cellular assault weakens the outer envelope to the point where it may rupture. Silicone has been found in tissues peripheral to the breast even in the absence of implant rupture, which further implies that attacking macrophages can cause bits of the silicone envelope to break off.

Numerous reports in the medical literature, as well as findings by manufacturers, have shown that a certain amount of silicone leaks, or "bleeds" through the outer casing of the implant jacket in every case, even when there is no rupture. This means that all women with silicone implants will experience some exposure to the gel. Silicone particles may come off the outside of the envelope, perhaps creating potential hazard for women with saline-filled silicone envelope implants as well.

Diagnosing Silicone Disease

Silicone disease, due to its varied nature, is an illness that requires a fitting together of a multitude of signs and symptoms. Unfortunately, a single lab test to confirm silicone disease, such as the one used to confirm strep throat, does not yet exist. Hence few physicians have been able to identify the disease in their patients, and therefore have instituted a long chain of blind testing and trial medications. Until very recently, most women who have become ill with a variety of seemingly unrelated disorders never dreamed that their problems might be caused by their implants. As a result, few thought it even worth mentioning to their doctors that they had them. Some women may feel embarassed discussing their implants with a physician; some never tell their internist, obstetrician, gynecologist, spouse, or lover that they had breast augmentation surgery. And because scarring is often minimal, depending upon the incision site, even a physical examination may not enable a doctor to spot an implantation.

To make diagnostic matters even more complex, great skill is required to conduct a pathological evaluation with a standard laboratory microscope in order to catch silicone particles in tissue. Far more sophisticated and expensive technologies, such as high-powered electron microscopy/X-ray dispersive analysis, can be used to identify silicone in the body, but this is far beyond what is generally available in most doctors' offices. Additionally, the early signs of silicone disease are often nonspecific, the types of symptoms that can occur in anyone. Later, as the illness proceeds, its symptoms often evolve into conditions that appear similar to non-silicone-induced rheumatic diseases, such as rheumatoid arthritis, lupus, and scleroderma ( a fibrotic thickening of skin and vital organs). This combination of nonspecific and rheumatic symptoms, all of which appear to be similar to other illnesses, makes misdiagnosis easy. What's more, a physician who sees only an occasional silicone disease patient may easily misdiagnose her symptoms as a rheumatic ailment not linked to her implants. But, should the physician develop an interest in silicone disease and see hundreds of patients with the same patterns, the pattern of silicone-induced signs and symptoms soon becomes clear.

It is important to understand that modern specialization and subspecialization in medicine lead physicians to develop exceptional skill in one area and little in others. Many of the plastic surgeons who insert breast implants stay away from any involvement in the postoperative, implant-induced medical complications of their patients, and most rheumatologists are not trained or experienced in plastic surgery procedures. Simply put, surgeons tend to focus on a single problem or area of the body. They will take a generally healthy patient, address a specific surgical problem--an infected gallbladder, for example--remove it, and be finished. Medical problems that might occur following surgery would normally be referred to an internist, family practitioner, or other medical specialist, because that's not what the surgeon handles. Because plastic surgeons only occasionally track their patients' recovery beyond a short time after surgery--more than a year or two is uncommon--many of those surgeons who used silicone-gel implants never knew that some of their patients developed silicone-related disorders later on. In one USF study, however, the average woman developed the onset of silicone disease symptoms about 4 1/2 years after implantation. Patients who suspect that they may be getting ill from silicone need to recognize the inherent complexity of this medical question as well as the training and orientation of their physician.

Symptoms

Silicone-related illness is a toxic problem. This is why toxicologists are now studying the illness. Typically there is a clustering of symptoms including any of the following: severe weight loss, hair loss, liver dysfunction, lymph node swelling, fatigue, weakness, granulomas, breast and nipple inflammation, skin shedding, circulation problems, arthritis pain, autoimmune symptoms, chronic muscle pain and stiffness. When the silicone leaches throughout the body, it wants to stay in the body. Any foreign matter, including silicone, is not easily transported out of the body. The body needs help in ridding itself of any potentially harmful agent. Studies are showing that the longer the silicone implants have been leaking or ruptured prior to removal, the less likely the women are to get well. As with arsenic--you can recover from a little, but after a long period of taking arsenic daily you may not fare so well. Women have died from the complications of this disease. If you have silicone implants, show this article to your doctor if he or she is not listening, or better yet, find another, more ethical and informed doctor.

Even the doctors studying the illness at universities are only beginning to understand? The irony is that the medical community helped to create this new disease, yet it firmly argues that it does not exist. Where is the responsibility of the medical community, not to mention the responsibility of the implant companies who produced defective products that got infected and made people ill? There are a significant number of physicians who are still trying to figure out why women are ill. Yet, the following facts take any guess work out of solving these mysterious illnesses.

1. Most silicone-filled breast implants leak or rupture on average after as little as 4.5 years.

2. The implant companies never intended for silicone to move out of the breast implant and indeed Dow Corning stated in its brochure that the implants would "last a lifetime".

3. Most series report a significant range of positive bacterial cultures around leaking and/or ruptured implants.

4. Women with advanced disease have similar symptoms to the miners who developed silicosis or silica in the lungs.

5. The initial epidemiological studies on this illness were flawed and the National Institute of Health panel has asked that they be repeated. These are the studies that were so well publicized in print and media. Of course, we did not hear on television or in the newspaper that they were found to be flawed and not large enough to be statistically significant. Another important factor to consider in any study is that those conducting the studies study women whose implants are less than 5 to 8 years old. Studying women with intact implants is like studying smokers of five years or less and concluding that cigarettes have no relationship to lung cancer.

The symptoms develop in a fairly predictable order and progressed with time. It is similar to a "toxic" problem in that the longer the toxin is in the body and the further it spreads (i.e. dose related) the more the symptoms progress. The symptoms often start in the chest wall on the side of the implant "leak." There is sometimes a burning sensation or a nonspecific discomfort that can radiate or travel down the arm. Often there is numbness, especially at night, of that arm that later involves all the extremities. Actual silicate crystals are found in the nerves, which explain why the disease affects the nerves in particular. The other early symptoms are nonspecific--easy fatigue, muscle aches, and increased susceptibility to infections. Most sufferers have increased frequency of viral infections, sinus problems, and yeast infections. Many of these women, who only get one cold a year, cannot seem to shake the viral illnesses and are sick for a longer period of time with bacterial and yeast infections as well.

Most patients experience an increased energy level and gradual relief of symptoms as the silicone is cleared from their body by natural means. Holistic methods are used to help speed up the detoxification process. To help support the immune systems, we recommend a combination of thymic factors, thyroid support, heavy metal detoxification, and antioxidant nutrients. The patient is started on these prior to surgery to help reduce complications, as the majority of these women have depressed immune systems. Inositol is recommended as well which is a vitamin that helps increase the amount of silicate the body eliminates in the urine.

Toxicology

Injections of silicone fluid under the skin in guinea pigs have produced severe granulomas (collections of macrophages). Granulomas have also been found in the breasts and livers of transsexual males who received silicone injections for breast enlargement. And epidemiological studies in Japan have reportedly shown substantial increases in specific rheumatic conditions in women who have received these injections. Other toxicology research, conducted by implant manufacturers from the 1960s through the 1980s and provided to the FDA, indicates that various silicone compounds injected into mice, rabbits, monkeys, rats, and dogs can spread throughout the body. Macrophages containing silicone particles have been found in test animals' adrenal glands, lymph nodes, liver, kidney, spleen, pancreas, and ovaries. Results form Dow Corning's biosafety animal study reports have included findings of liver toxicity, stillbirths, fetal abnormalities, respiratory diseases, lesions, cancer, hemorrhages, and death.

In mid-1982, Dow initiated a project with an internal mammary gel formulation labeled Q7-2159A to address the issues of gel cohesivity and bleed, the results of which "showed the extreme sensitivity of the formulated gel to penetration and bleed." Further studies with this particular formulation, variously conducted over a decade, revealed "metastatic sarcomas," "enlarged lymph nodes," "pituitary adenomas," and "hair loss that may be associated with thyroid disorders." A subchronic toxicity study with formulation D5, contracted to the University of Mississippi Medical Center in 1989, found the gel to "induce liver enlargement, with recovery after cessation of dosing," and it "resembled phenobarbital" in its ability to induce certain enzymatic activity.

The potential of free silicone migration was also raised to company officials in at least one report submitted in 1976 by an outside testing laboratory. Injecting a series of gel formulations labeled TX1228, TX1229, and TX1234, the researchers noted a "possibility that the test material may have migrated away from the implant sites." When viewed under a microscope, tissue next to silicone implants has, in some women, shown an exceptionally high accumulation of scavenger cell-devouring macrophages. Unlike the finite healing of a particular wound, the assault of macrophages around the silicone implant does not stop, because the body continues to respond to the tiny, but potentilly widespread, silicone particles. In many women who receive silicone breast implants, the macrophages keep accumulating month after month, year after year. As more cells arrive, the scar tissue becomes increasingly thicker--often creating a series of hard, painful lumps or overall hardening of the breast, in addition to the likelihood of changes in the physical contour of the breast itself.

Composition

Breast implants have changed in nature over a period. The earlier type comprised a silicone elastomer envelope containing a silica filler with attached Dacron sheeting, and containing a silicone gel. Later products consisted of a similar silicone elastomer envelope, also with Dacron attachments, filled with a silicone gel and sealed with a silicone polymer patch. These silicone substances are a small group of closely related polysubstituted siloxanes, containing simple alkyl groups for cross-linking and other purposes to control their physical properties. They are prepared from a small range of starting materials and are polymerized with a few specific reagents and catalysts to form polymers with specific properties. The gel used inside certain types of implant has an analogous composition. In addition the outer membrane of polyalkylsiloxane elastomer contains an inert filler, amorphous fumed silica, and a polyurethane coating has been applied to some products in the past. The adhesive is a further polyalkylsiloxane product, as is the patch used to seal the injection site in certain types of implant.

Chemicals in the explanted breast implant shell envelopes and gels:

Methyl Ethyl Ketone

Cyclohexane

Isopropyl Alcohol

Denatured Alcohol

Acetone

Urethane

Lacquer thinner

Ethyl Acetate

Epoxy Resin

Epoxy hardener

Amine

Printing ink

Toluene

Freon

Silicone

Lofol (formaldehyde)

Flux

Metal cleaning acid

Eastman 910 glue (Cyanoacyryiates)

Talcum Powder

Color Pigments as release agents

Oakite (a cleaning solvent)

Ethylene Oxide (ETO)

Carbob black

Xylene

Hexane

Hexanone 2

Antioxidant (rubber)

Zinc Oxide

Naphtha (rubber solvent)

Phenol

Benzene-Known carcinogen!

Polyvinyl Chloride (Liquid Vinyl)

Methylene Chloride/Dichloromethane

Polyurethane Foam Implants

Cigarette smoke, asbestos, radium, cyclamates, chromium, nickel, hardwood dusts--these are just a few of the many substances that at one time were thought harmless and have turned out to be contributors to cancer development. Today, these materials are known to take from 14 to 40 years to trigger cancer in humans. Polyurethane foam-covered implants may also join this lineup in the future. Foam-coated implants were originally designed to help prevent the natural scar tissue around implants from developing into capsular contracture. By the late 1980s, the foam-coated version ws the most popular breast implant, with an estimated 200,000 having been sold in the United States alone. These implants were marketed under such brand names as Meme, Natural Y, and Replicon.

It turned out that the lining of these implants, described in company documents as the "patented Microthane interface system," was discovered by a University of Florida chemist to produce a dangerous substance known as 2-tolulene diamine (TDA) when it was broken down, a known animal carcinogen, causing liver cancer in animals, and a suspected human one. But the implant's lining actually had another name: Scott Industrial Foam, used in automobile air filters and carpet-cleaning equipment. When the manufacturere of the foam, Scotfoam Corporation, found out in 1987 that this material was being surgically implanted in women, it notified the implant manufacturer that the company was "shocked." "We do not recommend such uses," wrote Scotfoam product control manager Edward Griffiths.

Studies later showed that the outer layer of foam could break down in the body. During a Florida liability lawsuit, the chemist who had analyzed the foam said that small amounts of TDA were produced in this breakdown. TDA is classified by the U.S. government as a hazardous waste and was banned for use in hair dyes in 1971; workers who handle it are advised to wear goggles, rubber gloves, and respirators. "TDA has been found in both the breast milk and urine of women with polyurethane-coated implants," reported a Wall Street Journal article. According to the FDA, about 10 percent of women with silicone-gel implants have those with polyurethane jackets.

Saline Implants

In 2002, 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). But new data just released by the very companies that manufacture saline implants show that their products have a surprisingly high rate of failure. These findings may explain why 43,600 women had their implants (both saline 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.

Faulty Devices

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 safety of their products. Findings from the first three years of the trials and some of the fourth-year data were released at FDA hearings in March 2000. 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 Anderson, M.D., former chair of the FDA's medical devices committee from 1984 to 1988 and currently associate professor of medicine at Johns Hopkins School of Medicine in Baltimore. Anderson 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. 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 David Feigal, M.D., director of the FDA's Center for 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 benefits of 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."

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, Maryland, 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, mucus-like 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 require a 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 months pregnant, 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 covered by 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 to live. 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. Feigal. "The whole purpose of the FDA approval process was to gather information so patients know exactly what to expect."

The Excruciating Pain

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 niger, aspergillis 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, 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. 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.

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 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.

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."

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 a silicone shell, just like the one that surrounds silicone-gel implants," points out Frank Vasey, M.D., chief of rheumatology at the University of South Florida. 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 Diana 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, it's up to women to make up their own minds--a conclusion shared by most medical professionals. Despite falling ill herself with unshakable fatigue, dizziness, muscle aches, numbness in her arms, dry eyes 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 be totally 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?"

Absorption and Distribution

Three factors influence the distribution (movement) of molecules in the body solubility, lipophilicity and molecular size/shape. For small molecules the last can be ignored, whereas for medium molecules the interplay of all three properties is critical. The molecular size/shape is the most important factor for large synthetic molecules. These molecules are mainly transported by specialised mechanisms e.g. following engulfment by cells.

Metabolism and Excretion

In order to excrete small molecules it is desirable to increase their hydrophilicity and/or size. This is the main function of foreign compound metabolism. Phase 1 reactions increase the hydrophilicity e.g. by hydroxylation whilst phase 2 conjugation reactions increase molecular weight. These reactions are performed by enzymes within the cell.

The distribution of silicone and its precursors is governed by the same processes. The silicone polymer (PDMS) is a large crosslinked molecule hydrophobic molecule that is essentially insoluble. The distribution of silicone polymer is essentially restricted to phagocytosis. The short chain linear and cyclic precursors have been demonstrated to absorb, distribute, metabolise and excrete in relation to their solubility, molecular weight and lipophilicity. As their molecular weight increases their solubility and oral absorption decrease, essentially reaching zero at more than 8 siloxy units.

For those short chain molecules where half lives were measured these were in the order of hours to days. The metabolism of the short chain precursors has been studied demethylation reactions have been shown to occur. However in no case has the loss of more than two methyl substituents been shown, there is no metabolism to silicates. There is no evidence of demethylation of silicone polymer, this probably reflects its inability to cross cell membranes and fit into enzyme active sites.

Overview

Silicone implants are silicone shells filled either with saline (salt water) or silicone gel, or a combination of the two. Some silicone gel implants are coated with a polyurethane material and are called Natural-Y implants. Silicone breast implant complications can be divided into two categories: local chest wall complications and more generalized "systemic" problems. Local complications include capsular contracture, or the tightening of scar capsule around the implant, malposition, and rupture and/or leakage of the implant.

Capsular contracture can cause local discomfort and upward displacement of the implant. Capsular contractures are believed to be the result of a low-grade infection around the implant. The low grade infection causes tightening of the normal scar around the implant and as the implant is squeezed, it appears more firm. Capsular contractures are more common when the implants are placed behind the breast tissue and in front of the chest wall muscles. This is believed to be due to the contamination of the implant from breast ducts, which normally contain some bacteria. If the implants are placed behind the chest wall muscles and the surgeon avoids cutting through the breast tissue, the incidence of capsular contractures is reduced. Irrigation of the surgical area with antibiotics has also been shown to reduce the risk of capsular contracture.

Malposition of the implant is usually due to capsular contracture. When the scar tissue tightens, the implant tends to ride up on the chest wall. Malposition can also be due to steroids placed in the pocket or saline implants during surgery. Steroids can thin the tissue, leading to a gradual downward migration of the implant. Rupture of the implant occurs when the silicone shell has a hole or a tear which allows the migration of the contents outside the shell. Saline is reabsorbed without difficulty but silicone gel is not as easily disposed of by the body. In most cases, the scar capsule around the implant contains the majority of the silicone gel. Leakage occurs when silicone "bleeds" through the silicone shell. The idea that microscopic silicone has spread throughout the body has been a source of concern for many women with ruptured and/or leaking implants.

For women who have migration of larger amounts of silicone gel outside of the scar capsule, the surgical removal of this material is more difficult. Again, however, the body tends to isolate the offending material with scar and other tissue designed to contain foreign material within the body. Fortunately, the majority of ruptures of silicone gel implants occur inside and are grossly contained by the scar capsule. Surgical removal of the scar capsule and ruptured implant is much easier if the silicone has not migrated into tissues outside of the scar capsule. It is important that the explanting surgeon use a technique that minimizes the risk of free silicone coming into contact with tissues and that the entire scar capsule is removed as it contains silicone particles in the majority of cases.

Pathological examination of the scar capsules surrounding the silicone gel implants often show macrophages filled with vaculated or foamy material. The macrophages are the body's scavenger cells, which attempt to ingest any materials which the body regards as foreign. Most silicone gel implants, especially those manufactured prior to 1985, were known to have small amounts of silicone gel "bleed" or leakage through this silicone shell. The breast implant manufacturers were aware of this phenomena and in the early 1980's Dow Corning developed a "low bleed" gel implant which had a different silicone shell that was less likely to have silicone gel bleed. It is assumed that the silicone gel bleed occurs to some extent in all silicone gel implants and this accounts for the foamy material found in the macrophages in the scar capsule. Even in patients with unruptured implants, it is assumed that some silicone gel travels beyond the shell of the implant.

The early silicone gel implants developed by Cronin had fairly thick silicone shells. These had a tendency to form capsular contractures and often had calcium deposits within the scar capsules. The tendency for implants to rupture increased when companies developed a thinner, more pliable silicone shell. The thinner shell developed in 1969 was widely used until the development of the low bleed implant in 1984. Further improvements in the silicone shell occurred in 1990 when a textured silicone shell was developed which was not only more resilient but was felt to reduce the incidence of capsular contracture.

Currently, plastic surgeons are able to choose between two types of saline implants. The smooth-wall saline-filled implants are felt to have fewer problems with wrinkling, and the textured saline-filled implants are felt to have a lower incidence of capsular contracture. Because the saline implants are a different (lighter) density than silicone gel implants, they tend to feel "sloshy" or less natural than silicone gel implants, especially if the woman has very little breast tissue to cover the implants. For this reason, it is usually recommend that saline implants be placed beneath the chest wall muscles as the muscle allows for additional coverage over the implant, so that wrinkles and irregularities are less noticeable. Placement under the muscle also reduces the risk of capsular contracture. For women who already have systemic symptoms, the use of smooth saline implants as textured implants are believed to have more risk of having silicone material separate from the implant. It is important that symptomatic women realize that the Silastic envelope of the saline implant is a silicone polymer that may breakdown in the body into silica thus possibly also eliciting an immune response.

In 1984, silicone gel implants coated with polyurethane were developed. This implant was called Natural-Y and was felt to produce a more natural feeling breast due to tissue ingrowths into the polyurethane material. There was a more pronounced foreign body reaction in the scar tissue around this implant and a higher incidence of problems with infection than with standard silicone gel implants. This implant was useful in that some patients, who developed capsular contractures around regular silicone gel implants, would not form contractures around this implant. The problem that has never been resolved is the potential of biological activity of some of the breakdown products of polyurethane. Some patients also experienced localized allergic reactions to the material. Polyurethane coated implants tend to be more difficult to remove as the tissue ingrowths are more advanced. Removal of the entire scar capsule around this implant is recommended, as the polyurethane foam is incorporated into the scar tissue. Natural-Y implants are no longer available for implantation.

The majority of the controversy regarding silicone gel implants centers around the relationship of these implants to systemic or more generalized disease. There is a similarity of the symptoms of these patients to patients with chronic infections, such as systemic Candidiasis or yeast infections. There seems to be a spectrum of severity, ranging from the patient who had mild chronic fatigue, occasional joint and muscles aches and normal lab tests, to a more debilitating illness, such as fibromyalgia with abnormal ESR's. The more severely ill patients have frank rheumatologic-like illness, similar to systemic lupus erethymatosis, scleroderma and rheumatoid arthritis, with evidence of multi-system involvement.

The finding of frequently positive cultures of the scar capsules upon explanation has led some plastic surgeons to speculate that a low-grade chronic infection around a silicone gel implant may lead to a chronic illness, in which the immune system is unable to eradicate the infection or dispose of the foreign body. The interesting question then raised is whether this, in some individuals, can progress to immunological disorders, similar to lupus, rheumatoid arthritis, or scleroderma. The presence of silicone gel outside the implants, as occurs in rupture or silicone gel bleed, may increase the potential for infection in the scar capsule. If this is the mechanism of disease, then removal of the scar capsule and implants, as well as antibiotic irrigation of the pocket and possible systemic antibiotics would seem reasonable. The placement of another foreign body within the same area would not be advisable.

If the silicone itself is somehow the main offender, the advisability of replacing the implant with a silicone shell filled with saline must be questioned. Can the body react to the silicone shell or is it only the silicone gel associated with an immune system reaction? Silica has been reported in lymph nodes in saline implant patients who have never had silicone gel implants. Several studies to date have not shown an increased incidence of traditional rheumatological disorders in groups of patients with silicone gel breast implants, however these studies do not appear to be looking for the atypical symptoms commonly seen in silicone patients. It appears that silicone is associated with more of a metabolic disorder in conjunction with an immune hypersensivity than a traditional inflammatory autoimmune disease. Despite the lack of evidence of widespread development of frank rheumatological disease in large groups of breast implants patients, symptoms of a progressive chronic disease in patients with silicone gel implants appear to correlate with the amount of gel leakage. Improvement of symptoms after removal of the scar capsule and implants is common. Patients often report return of their normal energy levels, sometimes within several weeks following surgery. Some patients only experience a partial improvement but most patients so treated have not had a progression of their symptoms unless large amounts of silicone gel still remain in the patient.

Currently, there is a heated debate as to the safety of silicone gel implants. But, since there is such a high rupture rate as silicone gel implants age, especially in the implants placed during the 70's and early 80's, the question of whether silicone gel implants should be removed based solely on the high incidence of rupture and/or leakage needs to be addressed. Unfortunately, no currently available test, including mammography, breast ultrasound or breast MRI can always diagnose rupture of the silicone gel implant within the capsule. There seems to be a high incidence of the onset of burning pain along with upper extremity numbness associated with implant rupture, even when these studies are negative.

It is advised that any woman with silicone gel breast implants who experiences a sudden changed in shape and/or contour of her breast, or develops burning pain or numbness and tingling in the arm, be evaluated by a ethical plastic surgeon for the possibility of implant rupture. If the patient has generalized symptoms, such as chronic fatigue and muscle and joint aches, especially if these symptoms are progressive, she should consider removal of the scar capsule and implant, even if the studies do not show a ruptured implant. If the symptoms are severe, replacement of the implants with saline implants is not recommended, as recovery is often delayed if the saline implants are replaced at the time of implant removal. For many women, the prospect of losing their breast fullness is not acceptable, so they are willing to risk a more prolonged recovery with reimplantation with saline implants at the time of implant and scar capsule removal.

In addition to removal of the scar capsule and implant, both local and systemic treatments with antibiotics help treat any subclinical infection in the area of the breast implant. Systemic fungal infections are treated if present and therapies that stimulate recovery of the immune system are advocated. Patients are advised to take Inositol to aid the body in the mobilization of silicate.

Treatment

DNR has created Body Soak-Gold for those women who have experienced ruptured silicone implants. Its design is to help activate the body’s own resources necessary for it to release and remove impurities resulting from leaching or ruptured implants. This can occur with each soak and for hours thereafter.

“Nearly one million American women have silicone breast implants and at least 96,000 believe they are seriously ill as a result. While conventional doctors discredit the problem and offer no solutions, an innovative treatment proves that the damage created by silicone implants is reversible."

This quote is from an article printed in Alternative Medicine Digest, Issue 10, January, 1996. This article reports on a new detoxification protocol developed by Lee Cowden, M.D., a cardiologist from Dallas, Texas, to deal with breast implants.

Central to this protocol is Liquid Needle Body Soak Gold. Of the 36 women who have followed Dr. Cowden's program by the date of this publication, all have experienced improvement. "Many women who take Body Soak Gold ozonated baths once daily will notice little white flecks floating in the bath water; these appear to be related to the implants."

Dr. Cowden states, "Women going through this detoxification program see white powdery flakes coming out in their urine and stools, usually in a matter of days to weeks, after which their symptoms start to abate and dramatically improve. Then their autoimmune disease, (lupus, arthritis, and multiple sclerosis-like symptoms) starts to resolve. Many women, once dependent on wheelchairs, crutches or canes, find they can walk and run again."

"Some people have argued that silicone implants have to be proven unsafe before the FDA can act to protect patients against their use," stated FDA Commissioner David Kessler in April 1992. "This is not so. The burden of proof is an affirmative one, and it rests with the manufacturer. We know more about teh life span of automobile tires than we do about the longevity of breast implants. And we do not know whether there is any link between implants and immune-related disorders and other systemic diseases. Until these basic questions are satisgfactorily answered, the FDA cannot approve these devices,"

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