Fw: POST-From Myrl-Beagles etc. (from Breast Implant Litigation Evidentiary Files)

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Sent: Tuesday, June 25, 2002 6:07 AM

Subject: POST-From Myrl-Beagles etc. (from Breast Implant Litigation Evidentiary Files)

Subj: Beagles etc. (from Breast Implant Litigation Evidentiary Files) Date: 6/25/02 1:16:38 AM Eastern Daylight Time From: myrlj@... (Myrl Jeffcoat) The following document has been converted to text from an image file from the "Discovery" documents of breast implant litigation CDs. Thank you for sending this our way. Myrl --- Memo Margaret Porter, OGC-1 through: Kalins, OCS; J. Callahan, DGRD, HFZ-410; L. Sheridan, ODE, HFZ-400 From: Task Leader, Breast Implant Review Team Subject: Animal Studies Relevant to Breast Implant safety Not in Dow's PMAs Date: January 10, 1992 The following documents are believed to be relevant to the assessment of the safety of the silicone gel breast implants but were not included in Dow Corning's PMA's for these devices. Food and Drug. Research Laboratories, Laboratory No. 86199 Phase C, November 29, 1968 "Chronic Implantation Studies of Polysiloxanes in Dogs." This is the so called "38 beagle Study." A 3 year study involving implantation of 11- silicon based materials with harvesting of implant samples at 3 and 9 months end sacrifices at 24 and 36 months. 'This is the study that reported thyroiditis (4/34 animals (11.7%), controls 0/3), solid follicles in thyroid (3/34 animals (8.8%), controls 0;3), and foci of microfollicales (11/34 animals (33%), controls 1/3 (33%). Dow Corning, Report No. 150, Series No. 1-7040, project NO. 7010, March 12,1985"Fate of Q7-2159A Gel Injected subdermal in Rats: Macro Observations. This is the study of a gel material labeled with the same code as that used to identify one of the 2 gels used in the current model of implants. The study invovled 35 rats with subdermal injection of the gel and sacrifice at 10, 21, 42, 84 and 168 days post injection. The implant sides were dissected free from surrounding tissues and fixed in 10% formalin. The fibrous tissue capsule surrounding the gel mass was bisected and the gel mass carefully removed and weighted. This study found 47% of the gel mass not recovered at 84 days of implantation and 48% not recovered at 168 days of implantation. Dow Corning Report NO. 130, Series No. 1-0740, Project No. 9581, March 30, 1983 -Fluorosilicone Coated Mammary Prosthesis: Gel-Bleed, Physical Properties and LaminateIntegrity." This is the study showing the decline with time of the physical properties of the shell, particularly the tensile strength. Report shows that low bleed barrier greatly reduces these effects in the 1 year time span studied but does not demonstrate that the loss of strength is over by 1 year. These are the major studies not found in FDA's possesstion that have a bearing on the evaluation of the safety and effectiveness of the silicone gel breast implants Theree are other studies not supplied by Dow that have been considered but these are not sufficiently rigorous to have an effect on an DFA decision. S. McGunagle FDA000054548