Women's Implant Support Newsletter ~ December 8, 1999
Date: Wed, 8 Dec 1999 07:42:35 -0800
From: "Myrl Jeffcoat"
myrl_jeffcoat@yahoo.comWebsite:
http://www.homestead.com/siliconecity~*~*~*~*~*~*~
A MESSAGE FROM UNEEDA
Myrl,
Just a short update on funds requested by attorneys as co-counsel to the TCC. (Received as of today 12-07-99)
From" Notice for Allowance of Compensation"
Blizzard & McCarthy (filed 11-30-99) for period 5-1-99 to> 10-31-9 fees=$451,842.50, expenses= $59,243.96 Total= $511,086.46
Verner, Liipfert, etc. (filled 11-29-99) for period 5-1-99 to 10-31-99 fees=$720,439.66, expenses=$106,614.41 Total=$827,054.07
Shermets, Chimko, Kilpatrick (filled 11-29-99) for period 5-1-99 to 10-3`1-99 fees= $50,004.00, expenses=$7,712.59 Total= $57,716.59
Kilpatrick Stockton LLP (filled 12-3-99) for period 5-1-99 to 10-31-99 fees= $266,857.50, expenses= $26,746.99 Total= $293,604.49
This represents a total of $1,689,461.61 billed to the bankruptcy for co-counsels to the TCC.
I think we have more representation than we can afford!
Who is making the "Big Bucks" here?
Who are these firms really representing?
The women or the attorneys?
Uneeda
~*~*~*~*~*~*~
MARTI JACOBS PICTURE AND TRIBUNE ARTICLE 11~30~99
This article has been placed on a webpage for viewing. The last little segment of the article was not included in the photo scan, but the majority of it is there. . .Myrl
http://www.homestead.com/siliconecity/marti_article.html
~*~*~*~*~*~*~
FROM THE FDA EVIDENTIARY FILES
FDA's General and Plastic Surgery Devices Panel has recommended that the agency allow silicone breast implants to remain on the market while the manufacturers compile additional data on their safety and effectiveness. A statement by Elizabeth Connell, M.D., chairperson of the panel, is enclosed.
CHAIR PERSON'S STATEMENT
Breast Implant Panel Meeting November 14, 1991
To begin with, I'd like to express my gratitude to the members of the advisory panel, some of whom rearranged their schedules at the last minute in order to be with us for the last three days. This was a longer-than-normal panel session, and we worked each day until well into the night. I think the panelists are returning home to a well-deserved rest.
In advising the FDA about breast implants, this panel of experts had two basic tasks. The first was to evaluate whether the scientific information presented to FDA by the four implant manufacturers was sufficient to show a reasonable assurance of the safety and effectiveness of these devices.
The panel carefully examined the data in the applications and found that they were not sufficient to establish with reasonable certainty that these devices are safe and effective. I should emphasize that this does not mean that we found evidence that the implants are unsafe. Instead, we found that there was not enough information to be certain about risks and benefits, on way or the other.
For example, the data did not make it clear what proportion of women experience the more common side effects of these implants, such as rupture or contracture, nor did they satisfactorily address the issue of whether the implants can interfere with mammography examinations to the point of compromising our ability to detect early breast cancer. The data also did not resolve the issue of long-term risks - for example, whether the implants can increase the risk of autoimmune disorders or cancer.
Having concluded that none of the applications from the four firms had enough information, our next task was to advise the FDA about whether continued availability of these devices would be necessary for public health. If the FDA decides that this is the case, then it may be possible to have them remain on the market, at least in some limited form, while the companies collect more data.
The panel voted unanimously that there is a public health need for these implants and thus that they should continue to be available while FDA requires the manufacturers to collect additional data to fill the gaps in knowledge about safety and effectiveness. Many of the panelists commented that the needs of augmentation and reconstruction patients should not be separated. Several panel members expressed the need for a breast implant registry, and others pointed out the importance of adequate informed consent for women. A strong theme throughout the discussion was the need for FDA to hold the companies strictly accountable for providing the necessary data without delay.
~*~*~*~*~*~*~
Study to Investigate the Possibility of an Association Between Multiple Myeloma and Silicone Breast Implants (B)
AUTHORS: Silverman StuartM D
AUTHOR AFFILIATION: Department of Veterans Affairs/Medical Center,
West Los Angeles, CA
SOURCE: FEDRIP DATABASE, NATIONAL TECHNICAL INFORMATION SERVICE (NTIS)
ABSTRACT: RPROJ/FEDRIP SILICONES; MULTIPLE MYELOMA;
CLAIM REPORTING; DATABASES, FACTUAL; BREAST IMPLANTS
INTRODUCTION & PURPOSE: The possibility has been raised recently of an association between multiple myeloma and silicone breast implants. It is important to know whether or not such an association exists. If it does, women with silicone breast implant can be advised of their relative risk of multiple myeloma and to consider explantation to avoid potential health risks. If there is no association between multiple myeloma and silicone breast implants, women who have them can be freed of unnecessary worry, avoiding panic to explant.
Studying a possible association between multiple myeloma and silicone breast implants is difficult. Prospective studies, while attractive scientifically, are impractical because of their cost and the time necessary to complete them.
Retrospective studies depend on the availability of suitable data. One way of identifying cases and controls for a retrospective cohort study would be through the claims databases of health insurers and managed care organizations.
Our clients include many of the nation's largest health insurers and managed care organizations. The purpose of this proposal is to assess the feasibility of studying a possible association between multiple myeloma and silicone breast implants using such existing databases. It consists of the following sections:
Project phases and methods Proposing organization Project personnel Schedule Funding request. Proposed project phases and methods We anticipate studying the possible association between multiple myeloma and silicone breast implants in the following three phases, with initiation of each subsequent phase predicated on successful completion of preceding phases: Phase I: Assess the feasibility of conducting the investigation by using data collected by Medical Care Management Corporation clients. Phase I: Design the investigation based on the feasibility assessment. Phase m: Implement study protocol.
This proposal pertains to phase I. We propose to hold structured discussions with approximately six client medical directors or other representatives to explore the availability of needed data and any conditions or foreseen difficulties related to payors' participation in the envisioned study.
KEYWORDS:
U.S. DEPT. OF TRANSPORTATION VA FEDRIP RPROJ SUPPORTING AGENCY: Department of Veterans Affairs/Research andevelopment
~*~*~*~*~*~*~
Tea Tree (Melaleuca alternifolia) Essential Oil
In 1770 crewmembers on British sailor James Cook's exploration of Australia's east coast became intrigued with an unusual species of small trees growing in swampy, lowland areas. Cook's crew boiled the sticky, aromatic leaves of the tree, later identified as a member of the myrtle family, to make a tea The name "tea tree" stuck, although if the sailors had consulted with Australia's Aborigines, we might know the plant as "wound tree" today, because these native peoples had long used the plant to cleanse and heal wounds. Medicinal use of the pale yellow oil distilled from tea tree leaves became more popular in Australia in the first decades of the twentieth century, and by the 1930s it was a widely respected medicine in that country. Australian tea tree growers were even exempted from serving in the country's military during World War II until a steady supply of the oil was assured for inclusion in first-aid kits.
Commercial production of tea tree is still centered in New South Wales, the only place in the world where the tree grows naturally. (Tea trees are now also being grown in plantations in Asia and other parts of the world.) Today the essential oil of the tea tree plant is recognized as one of the most effective natural substances for killing or inhibiting the growth of various types of microorganisms, such as bacteria, viruses, and fungi. Industrial grades of tea tree are used as disinfectants in detergents and other products, but a much more prominent use for the essential oil is as a natural first-aid remedy and a treatment for various types of infections and skin conditions. Tea tree has become so popular that during the past decade worldwide sales have skyrocketed from approximately 10 tons to 200 tons annually.
Benefits & Uses
Tea tree oil may be effective against a wide range of bacterial, viral, and fungal conditions, including athlete's foot ringworm, respiratory infections, and vaginitis As a first-aid remedy it readily penetrates the skin and is useful for treating burns scrapes, bites, stings, and various skin irritations. Some people find it to be an effective insect repellent.
A number of studies have found that tea tree oil can help to eradicate fungal infections of the nails, which are relatively difficult to control even with conventional prescription drugs. Tea tree is among the most popular essential oils used in aromatherapy whether by inhalation or in various bodycare products. Tea tree has a number of dental uses, as well.
Diluted in water it can be an effective mouthwash and gargle; in more concentrated forms it can help relieve canker sores cold sores, and gum disease. Tea tree oil may also help to prevent or treat acne, colds and the flu, yeast infections, warts, nasal congestion, and sore throat.
Recent findings
Australian researchers compared a 5 percent tea tree oil solution to 5 percent benzoyl peroxide for the treatment of acne The remedies' effectiveness rates were similar but the tea tree oil caused fewer side effects. Tea tree oil is effective against some of the strains of antibiotic-resistant bacteria, such as Staphylococcus aureus, that have become rampant in hospitals. Three recent in vitro studies have tested tea tree oil's ability to inhibit various types of microorganisms. One study that tested tea tree oil's activity against 58 types of microorganisms, including species of Candida, found it to inhibit all but one (a strain of Epidermophyton floccosum). A test of tea tree oil's activity against 64 strains of Malassezia furfur yeasts led researchers to conclude that "tea tree oil may be useful in the treatment of skin conditions involving M. furfur." Another study tested tea tree's antifungal properties against 26 strains of various dermatophyte species, 32 strains of Candida, and 22 M. furfur strains. Tea tree oil successfully inhibited all 80 types of pathogenic fungi. In a randomized, double-blind, placebo-controlled study of 60 subjects with fungal nail infections, researchers determined that a cream containing 5 percent tea tree oil and 2 percent butenafine hydrochloride cured 80 percent of patients after 16 weeks, compared to none in the placebo group.
Do scientists know how it works?
Scientists have identified approximately 80 of the estimated 100 compounds in tea tree oil, with a few of these compounds apparently being unique to the plant. Most of the compounds are chemically classified as either terpene hydrocarbons, such as pinene, or oxygenated terpenes, especially terpinen-4-ol and cineole. Terpinen-4-ol, which may account for up to 60 percent of the essential oil, is a powerful germicide and fungicide.
Cineole, which is also known as eucalyptol because it is prominent in the essential oil of eucalyptus, has expectorant and antiseptic properties. Australian product regulations require that tea tree oil must have at least 30 percent terpinen-4-ol and not more than 15 percent cineole. The cineole restriction, however, is not because cineole is inactive or toxic (its popularity as a component of many decongestant chest rubs testifies to its low rate of skin irritancy) but rather simply because higher levels of cineole in the essential oil derived from some varieties of the plant are associated with reduced levels of terpinen-4-ol.
Types of products
The pure essential oil is sold primarily in small dropper bottles of 1 to 2 ounces, though it is also available in sizes up to 8 ounces. Tea tree oil may be combined with vitamin E and with other essential oils, such as lavender. Tea tree oil is an ingredient in lozenges, sprays, suppositories, and first-aid creams. It is also used in virtually every type of bodycare product, including toothpastes, mouthwashes, lip balms, shampoos, conditioners, hand and body lotions, bar soaps, deodorants, body and foot powders, and face gels.
Safety
Tea tree is less toxic than many essential oils. It should be emphasized, however, that essential oils are extremely concentrated substances and need to be used with caution. Essential oils are generally diluted before being applied to the skin, and are not taken orally. Tea tree oil may irritate the skin in some individuals; test with a tiny amount on a small patch of skin. Tea tree can safely be applied full-strength in drops to finger- or toenails (for treating fungal infections, for example). It should not be applied to broken skin or near the eyes.
References
Bassett, I.B., et al., "A comparative study of tea-tree oil versus benzoyl peroxide in the treatment of acne," Medical Journal of Australia (1990), 153:455-58 Carson, C.F., et al, "Susceptibility of methicillin-resistant taphylococcus aureus to the essential oil of Melaleuca alternifolia," J Antimicrobial Chemother (1995), 35:421-24 Concha, J.M., et al., "Antifungal activity of Melaleuca alternifolia (tea-tree) oil against various pathogenic organisms," J Am Podiatr Med Assoc (1998), 88(10):489-92 Hammer, K.A., et al., "In vitro susceptibility of Malassezia furfur to the essential oil of Melaleuca alternifolia," J Med Vet Mycol (1997), 35(5):375-77 Hammer, K.A., et al., "In-vitro activity of essential oils, in particular Melaleuca alternifolia (tea tree) oil and tea tree oil products, against Candida spp," J Antimicrob Chemother (1998), 42(5):591-95 Nenoff, P., et al., "Antifungal activity of the essential oil of Melaleuca alternifolia (tea tree oil) against pathogenic fungi in vitro," Skin Pharmacol (1996), 9(6):388-94 Syed, T.A., et al., "Treatment of toenail onychomycosis with 2% butenafine and 5% Melaleuca alternifolia (tea tree) oil in cream," Trop Med Int Health (1999), 4(4):284-87
~*~*~*~*~*~*~
OTHER SILICONE RELATED RESOURCES ARE AVAILABLE THROUGH THE SILICONE WEBRING
http://www.homestead.com/siliconecity /webring
~*~*~*~*~*~*~*~*~
WHERE THERE'S SMOKE THERE'S FIRE ~ On The Net
The following websites have the "Where There's Smoke There's Fire" documents:
http://implants.clic.net/tony/Smoke/index.html
http://www.homestead.com/siliconecity/index.html
~*~*~*~*~*~*~
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.
http://implants.clic.net/tony/Myrl/index.html
~*~*~*~*~*~*~
TONI'S RABBIT POT PIE FOR THE SOUL
MAMMOGRAMS:
Many women are afraid of their first mammogram, but there is no need to worry. By taking a few minutes each day for a week preceding the exam and doing the following practice exercises, you will be totally prepared for the test, and best of all, you can do these simple practice exercises right in your own home.
EXERCISE 1:
Open your refrigerator door and insert one breast between the door and the main box. Have one of your strongest friends slam the door shut as hard as possible and lean on the door for good measure. Hold that position for five seconds. Repeat again in case the first time wasn't effective enough.
EXERCISE 2:
Visit your garage at 3 AM when the temperature of the cement floor is just perfect. Take off all your clothes and lie comfortably on the floor with one breast wedged under the rear tire of the car. Ask a friend to slowly back the car up until your breast is sufficiently flattened and chilled. Turn over and repeat for the other breast.
EXERCISE 3:
Freeze two metal bookends overnight. Strip to the waist. Invite a stranger into the room. Press the bookends against one of your breasts. Smash the bookends together as hard as you can. Set an appointment with the stranger to meet you next year and do it again. You are now properly prepared. Just a thought for all the women out there. MENtal illness, MENstrual cramps, MENtal breakdown, MENopause. Ever notice how all of women's problems start with men? Send this to all of the women you know and brighten their day!!! . and when we have real trouble, it's HYSterectomy.