Myrl Jeffcoat myrlj@jps.net
22 février, 2005 05:42
Thanks to Samantha for sending the following. It appears to be from evidentiary files of breast implant litigation. This one is important, because it gives us insight into some of the chemicals present in certain implants...Myrl
McGhan Implants Ingredients from FDA ~ Chief of PS Devices
Date: Sunday, December 05, 1999 10:20 AM
Subject: McGhan Implants
Ms. Pyron:
Your e-mail dated November 25 regarding McGhan Medical breast implants was forwarded to me. You had two inquiries: when your implants were manufactured and what are the material constituents. For the former, FDA does not have information on the date of manufacture of implants based on lot numbers. For this you can contact McGhan Medical in Santa Barbara, CA, 1-800-624-4261. Regarding the materials, this style of implant has a
silicone rubber shell and is filled with silicone gel. The silicone rubber contains the following substances:
1. small amounts (parts per million) of various smaller silicones
2. small amounts (50 - 100 parts per million) of metals like tin and platinum and very trace amounts of other metals
3. trace amounts of volatile materials like xylene and other organic compounds
4. considerable amounts (approximately 20 parts per hundred) of finely powdered silica that is tightly bound to silicone rubber pouch
The filler material contains silicone oil and silicone gel in addition to the four materials (chemicals) listed above.
I hope this answers your questions.
Sincerely,
Stephen Rhodes
Chief, Plastic and Reconstructive Surgery Devices
