Breast Implant Testing Information

 


Originally Composed 03/29/92 ----------------------------

Today (Monday March 29, 1992), I caught all but the first 5 minutes of the Jenny Jones' follow up show to the one she did a few weeks ago about silicone breast implants. I realize that few of us have the implants but many of us are concerned about the health of friends or relatives that have them.

Barbara Bertrand - 76304,2752

Here is a summary of the info and recommendations I heard:

Dr Edward Truppman PhD

* President of the American Society of Aesthetic Plastic Surgery

- Supports

1 A registry of breast implants and all medical implants.

2 Further research.($10 million has been allocated by Dow Corning for 24 + studies to be conducted by the American Society of Plastic and Reconstructive Surgeons to research auto-immune disorders, ruptures, mammography, capsular contracture, etc.)

3 Returning to your operating physician in order to facilitate gathering post-operative information for the doctors, yourself and others.

Dr. Melvyn Dinner MD

- Remove implants only if there is a problem.

- If a problem is mistakenly self-ascribed to the implants - upon removal the symptoms will likely abate or disappear due to a lessening of concern.

- All of us, but especially diabetics, have silicone in our bodies from disposable syringes with silicone lubricants (note: also hairspray)

- If silicone is in the lymphatic system "there is until now no evidence of problems or disease" (HIS words) from this.

- Alternatives to implants

- Flap procedure (expensive & painfull mastectomy reconstruction technique)

- Autologous fat transfer from tummy tissue or buttocks (with large scars and some underlying muscle taken) - 10 year old procedure NOT to be performed on those who smoke, are diabetic or overweight. He gave a typical $6000-8000 surgeons fee.

Dr. Norman Anderson MD

* Associate Professor of Medicine and Surgery at Johns Hopkins University

* one of the first to sound an alarm on silicone breast implants

* chairman of the first FDA panel on silicone breast implants

* consultant on latest panel on silicone breast implants

- We need an FDA mandated Universal registry of implanted medical devices by type and lot number.

- Of 12 breast implant manufacturers 9 are gone (and Dow Corning has stopped making them) and there have been 60 to 70 different variations of the breast implants.

- New implants include peanut oil & see-thru (as regards mammographic x-rays).

- Implant Rupture Rates - 0.4 % - Manufacturers Figure - 6-8 % - FDA Figure

- Dr. Pierre Balay (SP?) of Canada (on patients at time of removal because of capsular contracture or size adjustment) determined the following rupture rates (which Dr. Anderson said demonstrated the deterioration of the shell strength such that the oldest implants could rupture with a mammogram or even a firm hug):

- 5-7 years - Very few broke

- 7 + years - Increase in rupture rate

- 12+ years - 13 of 14 ruptured

- Capsular contraction is an indication of leakage. (note: all implants are said to have a slight slow-blead leak thru the shell, and milder capsular contraction will take place in the body's reaction to the silicone shell)

- Implant Rupture Symptoms

- Searing breast pain

- Chest wall complaints

- Shoulder-arm syndrome (muscle spasm and reflex nerve action)

- Fibro mialagia (general muscle stiffness)

(Note: Dr. Anderson said "this DOES NOT indicate lupus or sceleroderma but is hellishly difficult to treat.")

- Dr. Anderson, also commented on the FDA hearing testimony of Dr. John Sargeant, Chief of Medicine at St. Thomas Hospital in Nashville, who said about silicone gel implant ruptures as related to rhumatic disease (rhumatoid arthritus, lupus, sceleroderma, etc.) and mammograms, there is "not enough there to continue the moratorium."

Dr. Anderson stated that "it is also evident that he could not rule out that, although it [the breast implant] did not cause lupus it might make the lupus activate or [make it] worse".

- Tests For Augmented Breasts

- Recommended yearly Displacement Method Compression mammograms AND Ultrasound testing. (see below)

- Use Displacement Method Mammography rather than the Compression method for breast cancer detection, as the latter misses at least 50 % of silicone implant ruptures.

- For rupture detection use the "zero mammogram" from the Xerox Corp.

- Ultrasound is useful for supplementing mammograms in cases of silent rupture, bulges or herniated implants indicating threat of rupture.

- For those with polyurethane covered implants, a Urine test for TDA (TutolueneDiamine Acetate) breakdown products.

Here are some additional addresses and phone numbers:

The Command Trust Network 256 S. Linden Drive Beverly Hills, CA 90212 (Lists of doctors, tests, etc.)

International Breast Implant Registry 1-800-892-9211 (Fee - Will update you on your implant, optional participation in studies)

The Plastic Surgery Patient Relations Network hotline 1-800-635-0635 (for when you have a problem with your physician. They will give you referrals to locate an ASPRS Board Certified plastic surgeon.)

Dow Corning's Implant Information Center 1-800-442-5442 Will pay up to $1200 to women who need but can't afford surgery to remove implants - a procedure the company says can cost $1000 to $5000.

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Important deadlines and dates in the global breast implant settlement:

-- June 17: Deadline for implant recipients to comment, object or decline settlement.

-- Aug. 18: Fairness hearing before U.S. District Sam Pointer in Birmingham, Ala.

-- Sept. 16: Deadline for women claiming implant-related diseases to submit medical records for first round of payments.

-- Dec. 1: Deadline to remain eligible for money for medical evaluations, implant removal and other injuries not covered by disease compensation.

The toll-free information hot line for breast implant recipients is 1-800-887-6828. ------------------------------------------------------------------------------

12/06/93

Breast Implants-Test

HOUSTON -- A private laboratory says it has developed a blood test that could provide a simpler way for women to find out if their silicone breast implants have ruptured.

Some scientists, however, say researchers first must determine if silicone implants really are harmful. And one researcher dismisses the test completely.

Emerald Biomedical Sciences Inc. says the test measures antibodies created by the body in reaction to silicone, the substance used in devices implanted in more than 1 million American women.

"What we're finding is women with ruptures or leakage have significantly higher antibody levels," said Richard Furlin, president of the company based in The Woodlands, north of Houston.

Furlin said the lab is seeking approval from the Food and Drug Administration to market the test.

He said it could be used instead of surgery or expensive nonsurgical tests such as magnetic resonance imaging to determine if implants have ruptured or are leaking. He also said it might aid researchers in discovering whether a link exists between implants and disease.

Emerald said a study of its blood test shows women with known ruptures had higher levels of the antibody. Women with implants that were intact had slightly higher antibody levels than control subjects, Furlin said.

One researcher disputes whether an antibody test would be accurate.

"We know that most of the women who have breast implants have anti-silicone antibodies in their body," said Dr. Bernard Patten, associate professor of neurology at Baylor College of Medicine in Houston.

"We find that the women uniformly have higher elevations ... but the level of antibodies doesn't correlate with their disease or with other complications," said Patten, who is researching breast implant complications.

Results of Emerald's study were published this fall in the FASEB journal, the publication of the Federation of American Societies for Experimental Biology.

Susan Cruzan, an FDA spokeswoman, said it is against agency policy to comment on pending cases.

One group questions the usefulness of such a test, even if accurate.

"It's difficult to say, even if the antibodies are found, what the next step would be," said Laura Kopulos Asplund, spokeswoman for the American Society of Plastic and Reconstructive Surgeons, based in Chicago.

Ms. Asplund said that without proof that silicone or the antibodies cause any health problems, the test might only serve to unnecessarily alarm women.


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