Women's Implant Support Newsletter ~ December 16, 1999

Date: Thu, 16 Dec 1999 06:27:16 -0800

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FROM THE BREAST IMPLANT LITIGATION EVIDENTIARY FILES ~ FDA

CONGRESS 04/30/1992

STATEMENT BY DAVID A. KESSLER, M.D.

COMMISSIONER OF FOOD AND DRUGS and

FOOD AND DRUG ADMINISTRATION

PUBLIC HEALTH SERVICE

DEPARTMENT OF HEALTH AND HUMAN SERVICES

BEFORE THE SUBCOMMITTEE ON AGING, HOUSING, AND CONSUMER INTERESTS U.S. HOUSE OF REPRESENTATIVES

APRIL 30, 1992

FOR RELEASE ONLY UPON DELIVERY

I am David Kessler, Commissioner of Food and Drugs. I am accompanied by Jane Henney, FDA Deputy Commissioner for Operations, Carol Scheman, Deputy Commissioner for External Affairs and Margaret J. Porter, Chief Counsel for FDA.

We appreciate your continuing interest, Chairman Lloyd, in the difficult and complex issues related to FDA's decisions regarding silicone gel-filled breast implants. Your interest and concern are illustrative of the enormous consumer interest and intense public scrutiny of these issues.

This hearing is an opportunity to provide women with more information about the status of breast implants. The team of people who have headed our efforts in the review of silicone breast implants have worked long and hard and have reached an appropriate and responsible decision. This has been very much a team effort.

Since Dr. Henney's arrival at FDA just 4 months ago, she has led our scientific efforts, working closely with both the device center and our legal counsel, Ms. Porter. Ms. Scheman and Dr. Merkatz have spent an enormous amount of time listening to the needs and concerns of consumer organizations and individual women who need advice regarding our decision.

Ms. Scheman established FDA's breast implant hotline and will talk about that today.

I am here today to talk to you and to consumers about FDA's decision. Dr. Henney will discuss a number of scientific issues, including future research needs, and Ms. Scheman will talk about our work with consumers.

Madam Chairman, FDA is a consumer-oriented Agency. Virtually everything we do -- from reviewing the safety and effectiveness of prescription drugs and medical devices to improving the information contained on food labels -- has important implications for consumers.On this issue, it is critically important for us to continue the Agency's dialogue with consumers.Women need and are entitled to meaningful information regarding our decision, the future availability of breast implants, and the safety and effectiveness of the devices that were used.You are well aware, Madam Chairman, of the background to our recent decision, which is included in our written testimony. I request that our written statement be incorporated into the record of the hearing.This is the time to stop looking back. Today, I want to look to the future. Today is a day for all of us to come together, to work together, and to move forward.

BACKGROUND:

Silicone breast implants have been on the market since the 1960s. They pre-date the 1976 amendments to the Federal Food, Drug, and Cosmetic Act (the Act), which required FDA to review and approve the safety and effectiveness of many new medical devices. Those amendments also required FDA to establish a systematic way to collect and evaluate data relevant to devices on the market before 1976. Manufacturers of these devices, when requested to do so by FDA, are required by law to provide safety and effectiveness data even for devices, like breast implants, that had been marketed for many years.

FDA called for the safety and effectiveness data for silicone gel-filled breast implants on April 9, 1991. Let me emphasize that the law requires manufacturers to prove affirmatively, with valid scientific data evaluated by FDA, that their devices are safe and effective. Seven manufacturers submitted data in the form of Premarket Approval Applications (PMA). Applications from three of the manufacturers contained virtually no clinical information. In other words, those three manufacturers failed to meet the requirement of the law that they must submit adequate safety and effectiveness data to FDA. The remaining applications from four manufacturers did include some clinical data. However, the applications also contained major scientific deficiencies. In the Agency's opinion, none of the applications provided sufficient data to assure safety and effectiveness.

FDA brought to its General and Plastic Surgery Devices Panel the applications from these four manufacturers. Despite their major deficiencies, FDA believed these applications contained enough clinical data to merit an evaluation by the advisory panel. The purpose of the panel was to advise FDA as to what we could tell the public about the safety and effectiveness of these medical devices based on those data.

This advisory panel is composed of a broad range of experts, including representatives from the fields of plastic surgery, oncology, epidemiology, internal medicine, immunology, radiology, pathology, gynecology, toxicology, sociology, biomaterials, and psychology, as well as industry and consumer groups.

The panel spent three days, November 12, 13 and 14, 1991, from early morning to late evening listening to and analyzing data and anecdotal information, and hearing an extensive list ofindividual concerns from physicians and patients, advocacy groups and others. Significant concerns were discussed regarding implant rupture; bleed; and potential carcinogenicity of implant materials. Questions were raised about the possibility that an implant might interfere with the detection of breast cancer through mammography. On the other hand, many individuals who testified before the advisory panel presented information about the psychological benefits of implants. One full day was devoted to testimony from individual consumers, as well as consumer health and professional groups. The panel heard from those who strongly supported continued availability of these implants as well as from those who felt the devices were unsafe and urged FDA to remove them from the market.

The panel's deliberations resulted in a series of conclusions and recommendations. First and foremost, they concluded there were not sufficient data about the risks and benefits of these devices. Basic questions were unanswered regarding the chemical properties of the silicone gel, the physical properties of the implants, including the shell, and the possible toxic effects of implants. The panel agreed with the assessment of FDA scientists that the clinical data provided in the applications were not adequate to allay safety concerns. However, panel members expressed the view that the devices appeared to serve what could be viewed as a public health need.

They therefore recommended that silicone gel-filled breast implants should continue to be available under specified conditions and that a patient registry is needed while manufacturers collect additional data. They also urged FDA to hold manufacturers accountable to collect the additional data without delay.

After the meeting concluded, FDA became aware of information about the implants that was not presented to the panel. First, FDA was advised that some physicians and researchers were suggesting an association between connective tissue disorders and breast implants. The Agency contacted a large number of physicians who specialize in diseases of the immune system. These individuals confirmed that there was a concern regarding a possible link between silicone gel implants and the development of one of these diseases. Another matter that concerned FDA greatly was the ruling in a civil case against an implant manufacturer, where the jury verdict indicated that information about risks associated with breast implants had been inadequately conveyed to the consumer. After receiving some of the relevant documents from that case, it became increasingly clear that the advisory committee had come to its decision in November without the benefit of all of the information regarding the device.

We became convinced of two things. First, the advisory panel needed to revisit its recommendations in light of this new information. Second, we determined that consumers might be at greater risk than we had anticipated earlier. Therefore, on January 6, Dr. Kessler requested a voluntary moratorium on the distribution or implantation of silicone gel-filled breast implants until FDA and the advisory panel had an opportunity to consider the newly available information. The manufacturers agreed to comply with the voluntary moratorium.

Between the time of the moratorium and the April 16 announcement, another issue of grave concern to us came to light. The phenomenon of "silent rupture" was also brought to our attention. These were situations where ruptures were often undetected by the patient. In the case of rupture, the gel has the potential to spread through neighboring tissues. When rupture occurs, the standard practice is to have the device removed and replaced.

On February 18, 19 and 20, 1992, we reconvened the same advisory panel that had met in November. We did, however, add several additional non-voting members. Again, the panel members spent three arduous days in an attempt to reach a conscientious decision regarding the future availability of silicone gel-filled implants. The questions and concerns they had expressed at their earlier meeting still pressed for answers. Newconcerns were aired regarding the possible association between breast implants and connective tissue and immune disorders. Panel members consistently expressed surprise and dismay at the lack of data provided by the manufacturers, as well as heightened concern regarding the safety of the implants. At the conclusion of the February meeting, the advisory panel made a number of recommendations:

* Because of continuing concerns about the safety of the implants, their further use should be restricted to women participating in scientific protocols.

* Because of their special needs and benefits from the implants, women who need breast reconstruction should be allowed unrestricted access to the protocols. However, the augmentation (breast enlargement) patients in the> protocols should be limited to only the number needed to answer specific safety questions about the implants.

* Women with breast implants should be checked regularly by their physicians, even if they are not experiencing symptoms related to the implants. This is particularly true if they experience symptoms such as muscle or joint pain.

* If an implant has ruptured, it should be removed. Although "silent" rupture, which would be undetected by the woman, can occur, women with implants should not be routinely x-rayed to check their implants if they are not having problems.

* If a woman with implants is in the age group where mammography is recommended for breast cancer detection, she should be sure to have these examinations regularly. Women should be aware that special mammography techniques, which include additional views, are necessary in order to effectively detect breast cancer.

* In addition to the prospective registry of patients which would be established as part of the scientific protocols, a retrospective registry should be created which would enroll women who already have the implants. By this means, they could be notified of new information on the implants if this is necessary.

* Manufacturers must provide adequate preclinical data on the implants, such as the chemical and physical characterization of the implant materials and the implants' resistance to stress and rupture.

* In addition to the clinical data to be supplied by the scientific protocols, epidemiological studies should be done to answer questions about possible long-term risks such as whether the implants can cause immune-related and connective tissue disorders or increase the risk of cancer. Dr. Kessler committed the Agency to have its decision made within 60 days; April 20, 1992. The Agency announced its final decision on April 16, and this decision was consistent with the advisory committee's recommendations.

PRESENT STATUS

Where are we today relative to the regulation of silicone gel- filled breast implants?

What does FDA's April 16 decision mean for women?

What can FDA tell women about breast implants?

In brief, FDA's decision about silicone gel-filled breast implants is as follows.

The review of the Premarket Approval applications (PMAs) for these devices for use in breast reconstruction is still under way. The deadline for completing that review, as defined in the medical device law, has been extended based on public health need. The data required to complete the review must be collected by the manufacturers and submitted to FDA. Those data will come primarily from studies I will describe.

The PMAs for these breast implants for use in augmentation have been denied by FDA. The devices may be used for augmentation only with an Investigational Device Exemption (IDE), in an FDA-approved research study. Silicone gel-filled breast implants will be available only through controlled clinical studies. This is the way that we can answer the questions of women, doctors, and FDA, and those of our advisory panel of outside experts, regarding the safety and effectiveness of these implants. Manufacturers will be able to fulfill their legal, affirmative obligation to demonstrate the safety and effectiveness by conducting the required clinical studies. The availability of silicone gel-filled breast implants for clinical studies will be divided into three phases. As we stated April 16, an important caveat to companies going forward is compliance with Good Manufacturing Practice regulations. Good Manufacturing Practices are intended to assure that devices meet critical specifications, perform in the intended manner, are consistent with their design and do not present any unnecessary risks to users. For example, compliance with Good Manufacturing Practices assures the integrity of the breast implant shell, the consistency of the silicone gel and the sterility of the implant. In this way, we believe that Good Manufacturing Practices provide an essential element of "preventive medicine" to assure the quality of medical devices, as well as, other FDA regulated products.

The first stage is what we are calling the "urgent need" category. There is a group of women who may have an urgent need for silicone gel-filled breast implants and require immediate attention. This group can receive implants now. It includes women who have a tissue expander in place and are awaiting a permanent implant and add a second category of women who need their implants replaced without delay for medical reasons, such as implant rupture. Prior to the initiation of clinical protocols, it also includes women undergoing mastectomy for whom there is a medical and surgical necessity for concurrent reconstruction with these implants, and for whom saline implants are not a viable alternative. Physicians treating these women must certify this urgent need and secure the patients' consent through the use of a specially designed informed consent form from the manufacturer. It is critically important today for women to understand that doctors must inform them about the known risks of these devices and about the fact that there is a great deal we don't know. FDA is working closely with plastic surgeons and other physicians to assist them in determining how best to help their patients who may be in this urgent need group. There will be a second stage study available soon to all women who require silicone gel implants for breast reconstruction after breast cancer surgery; severe injury to the breast; or a medical condition causing a severe breast abnormality.

These women will be enrolled in clinical protocols designed by the breast implant manufacturers and approved by FDA. Physicians must certify that saline implants are not a satisfactory alternative for patients in these studies. Both the physician and the patient must agree to abide by the conditions of the protocol approved by FDA. One such condition is the enrollment of every patient in a registry so information can be collected by the manufacturers regarding the use of the devices, and so that future information about breast implants that becomes available as a result of these studies can be made available to all patients. In the third stage of implementing FDA's decision, highly-controlled research studies will be conducted to answer specific safety questions about the frequency and severity of certain known adverse effects of the implants, such as rupture and capsular contracture, or hardening. I want to emphasize that these questions were raised before, and discussed by FDA and the advisory committee. They are questions not answered by the manufacturers' data.

They must be answered now.

Protocols for the research studies are being developed by the manufacturers with FDA. The Agency has already been actively seeking and receiving input from consumers and health professionals in designing the studies. These studies will enroll both breast reconstruction and breast augmentation patients. The number of patients will be the number needed to achieve statistically valid answers to long-standing questions about the type and incidence of adverse effects, as well as the benefits of these devices. How can a woman learn about these studies? She should contact her physician. We will make information about the protocols widely known to health professionals and consumer groups, and we will work with health professional organizations to try to assure that doctors who participate, or whose patients wish to be considered for possible inclusion in these studies, have the information they need. We know you want this information. We are acutely aware of FDA's obligation to provide it as soon as possible. I want to turn the microphone over to Dr. Henney at this point, to discuss future research needs and how FDA is participating in designing the research agenda for breast implants.

One of the clear lessons of these past several months is that devices such as breast implants need careful study. Early in March, Dr. James Mason, the Assistant Secretary for Health, established a PHS task force, co-chaired by Dr. Dick Adamson of the National Cancer Institute and me, to develop a research strategy tostudy issues related to breast implants. This group expects to report to Dr. Mason by mid-summer on a research agenda for breast implants. Input has been sought from the health professional groups and consumer groups and manufacturers. Consumers, as well as FDA, must have answers to basic safety questions. For example, we do not know how long breast implants last in the body. We do not know how often certain adverse effects occur, such as contracture of the scar tissue that grows around the implants, which can be painful and cause disfigurement. We do not know how often breast implants rupture, how often they leak, or what effects escaped gel may have on other parts of the body or its systems. We also do not have adequate methods to diagnose rupture or leakage.

Some women have reported symptoms of immune-related or connective tissue disorders after having the implants. We do not know whether women with implants develop these conditions more often than women without implants. Although there is no proof that breast implants can increase the risk of immune-related or connective tissue disorders, women should be aware of the symptoms to look for and report them to their doctors. These symptoms include pain and swelling of joints, tightness, redness or swelling of the skin, swollen glands, unusual or unexplained fatigue, swelling of the hands and feet, and unusual hair loss. It is important to understand that these> symptoms are not necessarily related to the implants and that they can be indicators of other health problems. We do not know the carcinogenic effects, in any, of breast implants. The study that Dr. Adamson will described, will be extremely helpful in sheading light on these two important issues of concern to women, their physicians and the Agency. We are concerned that breast implants may interfere sometimes with cancer detection by hiding breast tissue when a mammogram is taken.

Although special techniques have been developed to overcome this problem, we do not know whether they are effective enough to afford implant patients the same degree of diagnostic certainty as other women in the detection of breast cancer. Women with breast implants who are in an age group where routine mammograms are recommended for detecting breast cancer should be sure to have these examinations at the recommended intervals. It is important to look for a mammographic facility accredited by the American College of Radiology, and to ask whether the personnel are trained and experienced in special techniques needed to perform mammography on women with breast implants. If these techniques are not used, breast cancer may be more likely to go undetected. The breast implant issue has prompted the Agency to set up a major outreach effort to address insurance issues for the benefit of consumers and to answer consumers inquiries directly. Carol Scheman will address these activities.

We recognize that insurance coverage for pre-Amendment medicaldevices, like breast implants, becomes a significant consumer issue when reimbursement for them stops due to FDA's process of evaluating the safety and effectiveness of a device. We are working with the Health Care Finance Administration (HCFA) to develop an orderly transition regarding insurance reimbursement when FDA calls for Premarket Approval Applications (PMA) for pre-Amendment devices. We are optimistic that in the very near future FDA will be able to provide HCFA the type of information needed so HCFA can make an informed reimbursement decision during FDA's regulatory review process. FDA is working with private third party payors as well on these same issues. We know that women are concerned about reimbursement for breast reconstruction with implants used in the future clinical studies. Although FDA does not determine the reimbursement policies of health insurance carriers, there appears to be no reason why any reimbursement for silicone gel-filled breast implants should change since the legal status of these devices used for reconstruction has not changed.

We have made a major effort to provide women with information about breast implants and remain committed to responding directly to consumers regarding their concerns about breast implants. We have received over 22,000 letters from consumers since October 1991 and almost 3,000 since the January moratorium. The magnitude of inquiries demonstrated that consumers needed easier access to information about breast implants. We announced on February 18 at the advisory panel meeting that FDA had established a toll free information service to provide accurate, up-to-date information to consumers to answer their growing concerns about silicone gel-filled implants. That toll free number continues to operate Monday through Friday, from 9 a.m. to 7 p.m. and is staffed with trained information specialists. Consumers can get answers to their questions about breast implants by calling 1-800-532-4440 or TDD #1-800-688-6167. To date, FDA has responded to over 34,000 telephone calls and has sent written information to over 26,000 consumers.

Our interactions with women on this important implant issue go beyond providing information. We have actively asked for their views. For example, fourteen leaders in women's health helped design the informed consent materials that will be used in the clinical studies. Prior to that, over 75 women with implants testified at our November 1991 advisory panel meeting. The advisory panel itself included three consumer advocates. The consumer testimonies, along with thousands of letters and phone calls to FDA from women who had or were contemplating implants, had a powerful impact on FDA's decisions. We have worked very closely with women's health organizations and cancer support groups to develop our policy. Rosemary Locke, who is scheduled to testify, has worked with us on many aspects of the breast implants issue--as a number of the working groups developing educational materials for women, coordinating a meeting between FDA and women with breast cancer and serving as a patient representative at our November and February advisory committee meetings.

As you know, consumers did not speak with one voice, nor did the health professionals and scientists we consulted. There has been considerable disagreement about the extent to which breast implants should remain available, in the face of serious uncertainty about their safety. We believe our current course of action meets the needs of women while our regulatory process continues and the manufacturers legal obligations are met. FDA must know, and women as well as their doctors need to know, whether the implants women may have in their bodies for decades are safe and effective.

From conversations with members of Congress and with women who are exploring the feasibility and advisability of silicone gel-filled implants either for reconstruction or augmentation, I have learned that there continues to be confusion about the differentiation between these two types of surgery. It is essential to note that restricted availability for augmentation purposes is not based on any value judgement. Rather, we believe these women have increased risk because unlike mastectomy patients, they still have breast tissue--therefore, mammography for detection of breast cancer is complicated. While special techniques for more complete mammography have been developed, experts continue to believe that breast implants can obscure full visualization of the breast. In addition, we remain very concerned about "silent rupture." The only reliable diagnostic procedure for such rupture in mammography. This is not advisable for young women with breast tissue because of the attendant excess exposure to radiation. As we gather new safety information, we will continue to need an effective way to get that information to women. The Agency is working with the manufacturers to establish a registry of women who already have breast implants. With a registry in place, we will be able to provide women who have implants important new safety information.

There are many aspects of this process that are coming together. To help women better understand what the requirements are for obtaining silicone gel-filled implants, we are preparing a briefing for consumers and women's organizations. This briefing is scheduled for June 1 and will focus on why we established our policy; what this means for women; what women should do to be considered for breast implants; registries; and informed consent.

This concludes the Agency's statement. My colleagues and I would be pleased to answer your questions.

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TOXIC REVELATIONS

Proponents of breast implants often refer to the frequent use of silicon in numerous products such as Mylanta, Mylicon drops, and baby bottle nipples to authenticate claims that silicone implants are not harmful. This ploy is analogous to comparing swallowing an aspirin to injecting cocaine. Yes, both cases would be considered "taking drugs," but they are in no way comparable. With silicon, the preparation with the highest concentration is Mylanta. It has less than one tenth of one percent silicon, whereas silicone breast implants contain about 45% (Balco Labs). Mylanta is taken infrequently, goes through the G.I tract and is excreted quickly. Silicone implants remain in the body in a leaky implant bag, 24 hours a day, 7 days a week, for decades. And consider all the other chemicals that are used in making silicone implant gel:

1. Methyl Ethyl Ketone 19. Metal Cleaning Acid

2. Cyclobexanone 20. Formaldehyde

3. Isopropyl Alcohol 21. Talcum powder

4. Denatured Alcohol 22. Color Pigments

5. Acetone 23. Oakite cleaning solvent

6. Urethane 24. Cyanoacyrylates

7. Polyvinyl chloride 25. Ethylene Oxide

8. Lacquer Thinner 26. Carbon black

9. Ethyl Acetate 27. Xylene

10. Epoxy Resin 28. Hexone

11. Epoxy Hardener 9. Hexanone 2

12. Amine 30. Thixon-OSN-2

13. Printing ink 31. Rubber

14. Toluene 32. Acid Stearic

15. Freon 33. Zinc Oxide

16. Silicone 34. Naptha (rubber solvent)

17. Flux 35. Phenol

18. Solder 36. Methylene Chloride

19 37. Benzene

Heavy metals such as aluminum and platinum were also used as catylist in turning the liquid silicone to gel. The devestating effects of metals on the human brain and body are well known. The combination of chemicals with platinum actually created a chemotherapy drug, (Platinol or Cisplatin) in a leaky implant bag. Is it any wonder why our hair is falling out? Chemotherapy drugs are self-limiting even for cancer patients because of their damaging toxic effects on the body.

So, what can they do to a healthy human body over a period of years? Also, silica was used as a filler. Silica is deadly in the lungs. Examine the autopsy reports of coal miners and those who worked in the marble and quartz quarries. The danger of silica has been recognized for decades. Slica is now being found in the tissues of sick women. Silica is being found in the original crystalline form. Silica is chemically breaking down from the "fumed" form from which it started.

The hazards of many of these toxic chemicals, such as benzenes are well known. They are carcinogens and known toxins, which can cause immune diseases, neurological manifestations, cancers and other disastrous problems in the body.

Court documents show the chemical compounds (including chlorplantinic acid) and silica that is contained in implants.

BREAST IMPLANTS WERE NEVER PROVEN TO BE SAFE! WHY ARE WE FIGHTING TO HAVE TO PROVE THEY ARE NOT! THERE SHOULD HAVE BEEN ENOUGH DEAD DOGS, CATS, GUINEA PIGS, RATS, MICE, MONKEYS AND RABBITS IN THE ARCHIVES OF HIDDEN STUDIES SO THAT WOMEN SHOULD NOT HAVE BEEN USED AS LAB EXPERIMENTS. HOWEVER, WITHOUT CONSENT, WE WERE THE GUINEA PIGS AND NOW WE ARE THE CLINICAL STUDIES THAT SHOULD HAVE BEEN PERFORMED BEFORE THE FIRST WOMAN WAS IMPLANTED! MOST OF THE MANUFACTURERS CHOSE TO SHUT DOWN THEIR PRODUCTION OF BREAST IMPLANTS RATHER THAN ATTEMPT TO PROVE TO THE F.D.A THAT THEIR PRODUCTS WERE SAFE IN THE HUMAN BODY!

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FACT OF THE DAY

In 1977, the Medical Engineering Corporation feared that because of liquid silicone transgression into the body tissue, the FDA would remove silicone gel implants from the market. A 1979 dog study showed low but definite concentrations of liquid silicone in kidney and liver tissue. They discovered that "rough handling of any sort will affect the gel cohesion of our mammary implants. The implant should be processed with minimum amount of handling." MEC, however, failed to warn the plastic surgeons and women of this phenomenon.

*From "Silicone-Gate" by Dr. Henry Jenny, Pg 73

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Herbal Rremedies

CATNIP

(Say Goodbye to Colds and Flu) The same stuff in catnip that makes felines go absolutely bonkers also lowers fevers, dries up postnasal drip, gets rid of sledgehammer headaches and relieves sore aching bones due to colds and flus. The active compound we're speaking about here has been designated as cis-trans-nepetalactone. An old Norwegian woman from one of the small Mormon communities in south-central Utah recalled how her own mother used to doctor her and all of her brothers and sisters with this herb when they were young. "Every ache and pain associated with childhood diseases or the miseries of influenza was successfully met with this little herb," she asserted. "No one was ever sick when they took their catnip every day." Besides as tea (2-3 warm cups daily), catnip may also be taken in gelatin capsules (4 twice or thrice daily on an empty stomach) or fluid extract (20 drops beneath the tongue once or twice daily as needed). The key here seems to be taking the herb with something warm. This nepetalactone exercises a strong stimulating effect on the brain's endorphins, which help to relieve pain, and on the immune system's white blood cells, which destroy harmful viruses. It is interesting to note that catnip's nepetalactone is somewhat similar in its chemical structure to the sedative valepotriates in valerian, which gives the plant its infamous "dirty socks" smell.

*From "The Power of Healing Herbs" by Dr. John Heinerman

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OTHER SILICONE RELATED RESOURCES ARE AVAILABLE THROUGH THE SILICONE WEBRING

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WHERE THERE'S SMOKE THERE'S FIRE ~ On The Net

The following websites have the "Where There's Smoke There's Fire" documents:

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FOR AOL MEMBERS OR OTHERS, WORKING WITH ON-LINE SERVICES NOT EASILY ACCOMMODATING THE FORMAT OF THESE NEWSLETTERS, YOU MAY ACCESS THEM FROM THE CANADIAN CONNECTION WEBSITE AT THE HYPERLINK BELOW. TONY & MICHELINE LAMBERT HAVE GRACIOUSLY ARCHIVED THEM FOR US.

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HUMOR

The Great Astrological Light Bulb Joke

How many members of your sign does it take to change a light bulb?

ARIES: Just one. You want to make something of it?

TAURUS: One, but just try to convince them that the burned-out bulb is useless and should be thrown away.

GEMINI: Two, but the job never gets done-they just keep discussing who is supposed to do it and how it's supposed to be done!

CANCER: Just one. But it takes a therapist three years to help them through the grieving process.

LEO: Leos don't change light bulbs, although sometimes their agent will get aVirgo in to do the job for them while they're out.

VIRGO: Approximately 1.000000 with an error of +/- 1 millionth.

LIBRA: Er, two. Or maybe one. No, on second thought, make that two. Is that OK with you?

SCORPIO: That information is strictly secret and shared only with the Enlightened Ones in the Star Chamber of the Ancient Hierarchical Order.

SAGITTARIUS: The sun is shining, the day is young, we've got our whole lives ahead of us, and you're inside worrying about a stupid burned-out light bulb?

CAPRICORN: I don't waste my time with these childish jokes.

AQUARIUS: Well, you have to remember that everything is energy, so....

PISCES: Light bulb? What light bulb?