McGhan Style 410's

[Guest guest]

Re: McGhan/Inamed Style 410 Mammary Prothesis

The McGhan/Inamed Style 410 is a textured Biocell silicone gel-filled, oval, low profile mammary prothesis of a kind not widely used in North America. It has a slightly thicker shell and is based on patents granted to 3m/McGhan (now Inamed). In the late-seventies. Such products are about the same as the McGhan/Inamed Implants distributed in North America prior to 1992 under stile 100, 110,etc. Style 410 devices do not make uses of any new concept.

Prosthesis similer to the Style 410 were withdrawn from Noth American distribution about 1992. Their use was then restriceted to Investigation applications. Most surplus stock was exported to the European market, some were relabled. A small number were Implanted in US & Canadian users who had received earlier gel prostheses and who demanded special exemption. The U.S. regulatory agency (FDA) granted U.S. users exemption on a case-by-case basis but required that patients sign special ‘clinical trial" style Informed Consent Authorizations. The use of these prostheses remains controversial to this day. Allegation of false representation mismanagement and failure to report adverse reactions have been made against Inamed and some physicians.

Style 410 Implants can leak, rupture and do as much damage as older designs. Because the textured surface occludes fluid and disintegrates easily, they have additional problems not found in the older implants. The gels separate into semi-solid and oily parts. The oil migrates through fatty tissue. The shells can and will rupture if given sufficiant time. They have poor fatiguue resistance on pleats & stress points. Rupture of the shell takes place along pleat lines with release of gel.

There is much misinformation about silicone gel type breast implants and how they cause disease. Some of this information has been known to part of the medical community for over 30 years (see attachment A). There is even more misinformation about saline-filled implant (see Attachment . There is an ongoing worldwide camgaign to increase breast implant usage. For this purpose, it is necessary to hide problems implants cause and the costs to nationa health and welfare programs from adverse reactions. It is important to make this information available to women who may be considering implants.

Women sho have received implants and may have suffered adverse affects are frequently involved in compensation programs. Most will require continuing medical treatments for many years. In some circumstances, Innoval can provide reports for legal purposes or for briefing treating physicians involved in the continuing medical treatment.

For your information, and the information of those in support groups, Appendix 2, attached, outlines work that Innoval can do, the type of reports that we prepare, their applications and approximate costs (in US dollars). We would be able to assist your members with identification of their implants and/or more detailed information as to how such implants affect health. Guidelines for sending material to Innoval are in Attachment C.

Yours truly,

P. Blais, Ph.D.,F.C.I.Cl

I still have to get all the referenced attachments, etc.

Martha Murdock, DirectorNational Silicone Implant FoundationDallas, Texas Headquarters

[Guest guest]

Martha Murdock, DirectorNational Silicone Implant FoundationDallas, Texas Headquarters

----- Original Message ----- From: MARTHA

ParfumGigi@...

Cc: CPR4WandF@...

Sent: Tuesday, May 08, 2001 2:03 AM

Subject: Fw: McGhan Style 410's

I had to re-type this letter sent to me from Marlou in Europe, after Ilena sent out conflicting information on this implant, etc. I have requested copies of attachments from Dr. Blais, as they were unreadable. This was faxed to me on 04/23/01 with the following questions & comments in the margins:

1) If it's untrue, why is she posting such shit?

2) Why is this so f**kn quiet?

1) Warning maybe? I think she doe not know this, please tell her!

2) Not vies any more -- Job to do girl -- It's Important everybody will know their new lies!

"Don't believe this Fairy Tale Honey" -- (Ilena's post -- 'Implants could make a comeback'

"Read & distribute following page re

Style 410

and

Women dont like this implant -- too hard & heavy & while sleeping the breasts stands straight up -- not!"

Marlou Booth

PS - A couple of other very brief handwritten notes I couldn't make out.

The letter only was sent for Ilena to post, which she never has to this day! Furious! You bet!

Martha Murdock, DirectorNational Silicone Implant FoundationDallas, Texas Headquarters

----- Original Message ----- From: MARTHA

ilena@...

Sent: Tuesday, April 24, 2001 2:04 AM

Subject: Fw: McGhan Style 410's

Ilena,

FYI!

Martha Murdock, DirectorNational Silicone Implant FoundationDallas, Texas Headquarters

----- Original Message ----- From: MARTHA

Cc: SBIPrayerForum

Sent: Tuesday, April 24, 2001 1:40 AM

Subject: McGhan Style 410's

Re: McGhan/Inamed Style 410 Mammary Prothesis

The McGhan/Inamed Style 410 is a textured Biocell silicone gel-filled, oval, low profile mammary prothesis of a kind not widely used in North America. It has a slightly thicker shell and is based on patents granted to 3m/McGhan (now Inamed). In the late-seventies. Such products are about the same as the McGhan/Inamed Implants distributed in North America prior to 1992 under stile 100, 110,etc. Style 410 devices do not make uses of any new concept.

Prosthesis similer to the Style 410 were withdrawn from Noth American distribution about 1992. Their use was then restriceted to Investigation applications. Most surplus stock was exported to the European market, some were relabled. A small number were Implanted in US & Canadian users who had received earlier gel prostheses and who demanded special exemption. The U.S. regulatory agency (FDA) granted U.S. users exemption on a case-by-case basis but required that patients sign special ‘clinical trial" style Informed Consent Authorizations. The use of these prostheses remains controversial to this day. Allegation of false representation mismanagement and failure to report adverse reactions have been made against Inamed and some physicians.

Style 410 Implants can leak, rupture and do as much damage as older designs. Because the textured surface occludes fluid and disintegrates easily, they have additional problems not found in the older implants. The gels separate into semi-solid and oily parts. The oil migrates through fatty tissue. The shells can and will rupture if given sufficiant time. They have poor fatiguue resistance on pleats & stress points. Rupture of the shell takes place along pleat lines with release of gel.

There is much misinformation about silicone gel type breast implants and how they cause disease. Some of this information has been known to part of the medical community for over 30 years (see attachment A). There is even more misinformation about saline-filled implant (see Attachment . There is an ongoing worldwide camgaign to increase breast implant usage. For this purpose, it is necessary to hide problems implants cause and the costs to nationa health and welfare programs from adverse reactions. It is important to make this information available to women who may be considering implants.

Women sho have received implants and may have suffered adverse affects are frequently involved in compensation programs. Most will require continuing medical treatments for many years. In some circumstances, Innoval can provide reports for legal purposes or for briefing treating physicians involved in the continuing medical treatment.

For your information, and the information of those in support groups, Appendix 2, attached, outlines work that Innoval can do, the type of reports that we prepare, their applications and approximate costs (in US dollars). We would be able to assist your members with identification of their implants and/or more detailed information as to how such implants affect health. Guidelines for sending material to Innoval are in Attachment C.

Yours truly,

P. Blais, Ph.D.,F.C.I.Cl

I still have to get all the referenced attachments, etc.

Martha Murdock, DirectorNational Silicone Implant FoundationDallas, Texas Headquarters