A number of women have asked me to write to the editor of the Breast Implant Centre newsletter in response to Dr. Clugston’s statements on saline implants. I obtain my information from Dr. Pierre Blais, Dr. Guidoin, Dr. Ira Lewy, Dr. Bernard Patten, Dr. Garry, Dr. Karjoo, and the FDA Report to Congress, 1992.

The FDA has assigned saline implants as Class III medical devices, which is the category that requires proof of safety and effectiveness. The FDA is still waiting for the manufacturers to prove safety; this proof is now ten years overdue. In the US they were grandfathered onto the market. In Canada there is no grandfathering provision. Saline has a shelf-life of less than one year. Hospital personnel will not wash a scratch with outdated saline as clinically it is considered unsafe.

Saline implants were popular in the 1960’s but because of fungus, particularly aspergillus niger, they were abandoned in favour of silicone gel. Their use is now on the increase since the ban on silicone gel by the FDA in 1992.

All elastomer shells used for implants are semi-permeable. The saline fluid flows out and body fluid flows back in. Dr. Blais, a scientist, biochemist, and specialist in medical product design and failure analysis, has tested many hundreds of implants. He states in several reports to the FDA: "Silicones of the type used here are permeable. They also incorporate large amounts of leacheables. They are compounded mixtures of large and small molecules that include unbound oils and mineral fillers. When made into shell membranes, they are very water and gas permeable from the outset. As implants age shell permeability increases." The debris becomes visible to the naked eye very soon, similar to a dirty fish tank. A woman then has two septic waste dumps on her chest.

Dr. Blais states: "Frank perforations ultimately develop when fatigue leads to fine crevices that propagate across the full thickness of the shell. The tissue around it ... forms an abrasive substance, a material like sandpaper which will ensure the demise of the prosthesis well within the 5-year limit" (page 20 of the FDA Report).

Manufacturers will replace a failed implant, up to how many years I am still not clear on that. However, the surgeons fee, hospital and or surgical suite fee, anesthetist fee, and other related costs are paid by the woman when the implants are for cosmetic reasons. All deflated shells must be removed along with the capsule, no matter how many deflations occur.

Why is the FDA today taking legal action against Mentor Corporation and Mentor Texas Inc. at the rate of $10,000.00 per day? "Deficiencies that FDA discovered include failure by Mentor to validate its manufacturing process and failure to adequately correct or prevent quality problems. FDA found that the implants may have the potential for problems with the exterior shell and also the packaging of the product. Potential problems with the exterior shell include defects such as bubbles, creases, or the thinness or thickness of the shell, and could result in implants that would be more likely to deflate or rupture. Potential problems with packaging of implants can affect the sterility of the implants. In the past, Mentor has experienced problems with the outer and inner seals opening at the same time (before surgery), potentially contaminating the product.". We know from the FDA reports that all substandard implants are sent to other countries, including Canada. The very best are kept for the U.S.A.

McGhan has been trying to lessen the silica filler in their salines, a known irritant. In 1974, T. Kolobow reported that blood clotting time with silicone elastomer containing filler was less than half that compared to pure silicone polymer.

FDA reports capsular contracture to be around 40% with all breast implants. Dr. Bernard Patten tells us in documentation he sent our society in 1991, that there is little difference between silicone gel and saline implants in all related problems.

Health and Welfare Canada have stated in information to our society that under no circumstances do you get a mammogram, not with the coil or special technique. Only have an ultrasound!! Mammograms weaken implants and often break them.

Implants are not for life, just as tires on a car wear out and need replacement. When we understand that implants also hide cancer of the breast, and we are assured that two women in ten get cancer of the breast, that is reason enough to never get them.

I encourage and invite all enquiries.

Sincerely,

Adella Matthew

President