EXHIBIT G2--Implant Brands and Manufacturers
The left-hand column is a list of companies, implant brands, "designer" implant names, and other names or phrases that might be used in medical records to describe a particular type of breast implant. The column to the right identifies the company with which that brand is associated for purposes of the Foreign Settlement Program ("FSP"). If implantation date ranges are supplied for an implant, an appropriate notation is to the right of each date range. Only implants identified as Bristol, Baxter or 3M are covered in the FSP.
BRAND/MANUFACTURER NAME | STATUS IN FOREIGN SETTLEMENT PROGRAM |
---|---|
3M | 3M |
AHS | Baxter |
Aesthetech | Bristol |
Alloplastic | Not Covered |
American Heyer-Schulte | Baxter |
American Hospital Supply | Baxter |
Arion | Not Covered |
Ashley Implanted before 9/1/71 Implanted 9/1/71 to 12/8/78 Implanted after 12/8/78 |
Bristol Baxter Bristol |
Baxter | Baxter |
Bebe | Not Covered |
Beckein | Not Covered |
Becker | Not Covered |
Beckman | Not Covered |
Biocell | Not Covered |
Biodimensional | Not Covered |
Biofill | Not Covered |
Biomanufacturing | Not Covered |
Bio-oncotic | Not Covered |
Bioplasty | Not Covered |
Biospan | Not Covered |
Birnbaum | Baxter |
Cabot | Not Covered |
Calcorian | Not Covered |
Capozzi Implanted before 9/1/71 Implanted after 8/31/71 |
Bristol Baxter |
Cavon | Bristol |
CBI Medical | Bristol |
Controle Medicale | Not Covered |
Cooper Surgical | Bristol |
Corbet | Bristol |
Cox Uphoff | Not Covered |
Cronin | Dow Corning (Not Covered--but must list on Claim Form) |
Cunard | Not Covered |
CZV/CRS (Croissant Versafil Low Profile) | Not Covered |
Dacron | Not Covered |
Dahl | Bristol |
Datron | Not Covered |
Delayell | Not Covered |
Delcon | Not Covered |
Directa Span | Not Covered |
Donnell | Not Covered |
Dow Corning | Dow Corning (Not Covered--but must list on Claim Form) |
DRI | Not Covered |
DRIE | Not Covered |
Dubin | Not Covered |
DuPont | Not Covered |
Edward Laboratories | Baxter |
EHP (Enhanced High Profile) | Not Covered |
Edward Weck & Co. Implanted before 9/1/71 Implanted 9/1/71 to 12/8/78 Implanted after 12/8/78 |
Bristol Baxter Bristol |
Elicon | Not Covered |
Emory | Not Covered |
Etheron | Not Covered |
Euromed | Not Covered |
Euro-Silikon (or Euro-Silicone) | Not Covered |
Fernander | Not Covered |
Flat Span | Not Covered |
FZV/SFV (Round Versafil LP Tissue Expander) | Not Covered |
Georgiade | Bristol |
Gibney | Not Covered |
Grossman | Not Covered |
Guthrie Implanted before 9/1/71 Implanted 9/1/71 to 12/8/78 Implanted after 12/8/78 |
Bristol Baxter Bristol |
Hamricksholler | Not Covered |
Hartley | Baxter |
Heyer-Schulte Implanted before 3/31/84 Implanted after 3/30/84 |
Baxter Generally not covered; may be Baxter on special proof--see explanation following table |
Heyer-Schulte Mentor | Not Covered |
Higer-Sol | Not Covered |
Hoest | Not Covered |
Hypoplastic | Not Covered |
Hyra | Not Covered |
Integra | Not Covered |
Intrashiel Implanted before 8/3/84 Implanted after 8/2/84 |
3M Generally not covered; may be 3M on special proof--see explanation following table |
Intravent | Not Covered |
IOC (Cylindrical Intraoperative Tissue Expander) | Not Covered |
IOM (Intravent Intraoperative Expander) | Not Covered |
IOS (Spherical Intraoperative Tissue Expander) | Not Covered |
Isle | Not Covered |
Ivalon | Not Covered |
Jackson | Not Covered |
Jellco | Not Covered |
Jenny | Baxter |
Jobe | Baxter |
Johnson & Johnson | Not Covered |
Jonas | Not Covered |
Klein | Not Covered |
Koken | Not Covered |
Lab Sebbin | Not Covered |
Lambardozzi | Not Covered |
Lepetit Pharmaceutical | Not Covered |
Litz | Not Covered |
Mammatech | Not Covered |
Magna-Site | Not Covered |
Mann | Not Covered |
Mark/M Surgical Implanted before 9/1/71 Implanted 9/1/71 to 12/8/78 Implanted after 12/8/78 |
Bristol Baxter Bristol |
Markham Implanted before 9/1/71 Implanted 9/1/71 to 12/8/78 Implanted after 12/8/78 |
Bristol Baxter Bristol |
Markham Medical Int'l Implanted before 9/1/71 Implanted 9/1/71 to 12/8/78 Implanted after 12/8/78 |
Bristol Baxter Bristol |
Mathe | Not Covered |
Maxwell | Not Covered |
McCormick | Not Covered |
McGhan Implanted before 8/3/84 Implanted after 8/2/84 |
3M Generally not covered; may be 3M on special proof--see explanation following table |
McGregor | Not Covered |
MEC | Bristol |
Medasil | Not Covered |
Medical Engineering Corporation | Bristol |
Meme | Bristol |
Meme ME | Bristol |
Meme MP | Bristol |
Mentle | Not Covered |
Mentor | Not Covered |
Metarse | Not Covered |
MFE (Man Facelift Expander) | Not Covered |
MFP | Dow Corning (Not Covered--but must list on Claim Form) |
Microcell | Not Covered |
Misty | Not Covered |
Misty Gold | Not Covered |
Morgantil | Not Covered |
MSI | Dow Corning (Not Covered--but must list on Claim Form) |
Mueller Implanted before 1/1/68 Implanted 1/1/68 to 8/31/74 Implanted 9/1/74 to 10/31/78 Implanted 11/1/78 to 3/30/84 Implanted after 3/30/84 |
Not Covered Dow Corning (Not Covered--but must list on Claim Form) Not Covered Baxter Generally not covered; may be Baxter on special proof--see explanation following table |
Mulligan | Not Covered |
Munna | Bristol |
Nagor | Not Covered |
Nagotex | Not Covered |
Natrashiel | 3M |
Natural Y Implanted before 9/1/71 Implanted 9/1/71 to 12/8/78 Implanted after 12/8/78 |
Bristol Baxter Bristol |
NFP (Non-Fixation Patch) | Dow Corning (Not Covered--but must list on Claim Form) |
Nicola | Not Covered |
Norman | Bristol |
Nortec | Not Covered |
OHP (Oval High Profile) | Not Covered |
OLP (Oval Low Profile) | Not Covered |
Optimam | Bristol |
Pangman | Baxter |
Papillon | Bristol |
Paragel | Not Covered |
Pardue | Not Covered |
Perifil | Not Covered |
Perras | Bristol |
Perras-Papillon | Bristol |
Phillips | Not Covered |
Plastigel | Not Covered |
Plastone | Not Covered |
PMT | Not Covered |
Polyurethane Implanted before 9/1/71 Implanted 9/1/71 to 12/8/78 Implanted after 12/8/78 |
Bristol Baxter Bristol |
Poly Plastic Implanted before 9/1/71 Implanted after 8/31/71 |
Bristol Baxter |
Poly Plastic Adjustable | Baxter |
Porex | Not Covered |
Precision | Not Covered |
Process Mankind Technology | Not Covered |
Promotel | Not Covered |
Quin-Seal | Bristol |
Radovan | Not Covered |
Rand | Not Covered |
RCP (Round Conical Profile) | Not Covered |
RCR (Ruiz-Cohen Expanders) | Not Covered |
RDD (Reverse Double Lumen DRIE) | Not Covered |
RDL (Reverse Double Lumen) | Not Covered |
RDL-XPAND | Not Covered |
RDX (Round Double Lumen) | Not Covered |
Regetect | Not Covered |
Replicon | Bristol |
Reverse Double Lumen | Not Covered |
RHD (Round High Profile) | Not Covered |
RHP (Round High Profile) | Not Covered |
RLD (Round Low Profile DRIE) | Not Covered |
RLP (Round Low Profile) | Not Covered |
Roger Klein | Not Covered |
RTV | Not Covered |
RTV/RTT (Smooth/Textured) | Not Covered |
Ruben | Not Covered |
Rubicon | Not Covered |
Ruiz-Cohen | Not Covered |
Ryscien | Not Covered |
RZV/SRV (Rectangular Versafil Tissue Expander) | Not Covered |
Satin Lacey | Not Covered |
SCC (Cylindrical Tissue Expander) | Not Covered |
SCL | Bristol |
SCS (Crescent Tissue Expander) | Not Covered |
Sealthen | Not Covered |
SEE (Mini-crescent Tissue Expander) | Not Covered |
Sebbin | Not Covered |
Secrofft | Not Covered |
Serbital | Not Covered |
Seropian | Baxter |
SFS (Saline Fill Skin and Tissue Expander) | Not Covered |
SGO (Saline Gel Oval) | Not Covered |
SGR (Saline Gel Round) | Not Covered |
Silastic | Dow Corning (Not Covered--but must list on Claim Form) |
Silastic II | Dow Corning (Not Covered--but must list on Claim Form) |
Silastic II MSI | Dow Corning (Not Covered--but must list on Claim Form) |
Silicone Medicale | Not Covered |
Silimed | Not Covered |
Silitex | Not Covered |
Silitex Becker | Not Covered |
Silitex Spectrum | Not Covered |
Simiplast | Not Covered |
SLP (Single Lumen Adjustable) | Not Covered |
SLS (Longitudinally Curved Tissue Expander) | Not Covered |
Snyder | Bristol |
SOE (Small Oval Tissue Expander) | Not Covered |
Sofgel | Not Covered |
SOS (Ear Shaped Tissue Expander) | Not Covered |
Spectrum | Not Covered |
SPS (Pear Shaped Tissue Expander) | Not Covered |
SRS (Rectangular Tissue Expander) | Not Covered |
SSS (Spherical Tissue Expander) | Not Covered |
Sterling | Baxter |
Storz | Not Covered |
Summit Medical | Bristol |
Surgical Specialities | Bristol |
Surgitek | Bristol |
Surigel | Not Covered |
Switek | Not Covered |
SWS (Wedge Shaped Tissue Expander) | Not Covered |
Synopsis | Not Covered |
Syntech | Not Covered |
SZR (Round Low Profile Sizer) | Not Covered |
Tab Products | Not Covered |
Tabari | Baxter |
TBD | Not Covered |
Tecknar | Not Covered |
Tis-U-Sol | Not Covered |
TLL (Triple Lumen Round) | Not Covered |
Travenol | Baxter |
Tri-Lumen | Not Covered |
TRL (Tri-Lumen Implants) | Not Covered |
TSO (Triple Lumen Low Profile Oval) | Not Covered |
TSR ( Triple Lumen Round Low Profile) | Not Covered |
UHP | Not Covered |
Ultra High Performance | Not Covered |
Unimed/Unitech | Not Covered |
Uroplasty | Not Covered |
Usign | Not Covered |
Varifil | Dow Corning (Not Covered--but must list on Claim Form) |
Versafil | Not Covered |
V. Mueller Implanted before 1/1/68 Implanted 1/1/68 to 8/31/74 Implanted 9/1/74 to 10/31/78 Implanted 11/1/78 to 3/30/84 Implanted after 3/30/84 |
Not Covered Dow Corning (Not Covered--but must list on Claim Form) Not Covered Baxter Generally not covered; may be Baxter on special proof--see explanation following table |
Vogue | Bristol |
Wagner | Baxter |
Webster | Bristol |
Weck Implanted before 9/1/71 Implanted 9/1/71 to 12/8/78 Implanted after 12/8/78 |
Bristol Baxter Bristol |
Weiner | Not Covered |
Wenthol | Not Covered |
Wilshire Tech | Not Covered |
Williams | Baxter |
Wood | Bristol |
For a Heyer-Schulte, Mueller, or V. Mueller implant implanted after March 30, 1984, to be considered a Baxter implant for purposes of the FSP:
You must provide proof that your implants have a Baxter lot number or the implant package label showing that it is an American Heyer-Schulte or American Hospital Supply implant. This list of Heyer-Schulte lot numbers qualifying as Baxter implants is available upon request from the Claims Office. A catalog or style number is not the same as a lot number. Heyer-Schulte catalog and style numbers do establish that implants are Heyer-Schulte, but do not allow us to classify them as Baxter if implantation was after March 30, 1984.
For a McGhan or Intrashiel implant implanted after August 2, 1984, to be considered a 3M implant for purposes of the FSP:
You must provide proof that the implant had the name "3M" on it or that it has a 3M serial number or that it has a catalog number that was only used by 3M (and not also used by McGhan after August 2, 1984). The list of 3M serial numbers, as well as the list of McGhan and 3M catalog numbers, is available upon request from the Claims Office.
Inquiries about specific lot and catalog numbers should be faxed to the Claims Office at 713-951-7010, or addressed to Claims Assistance Counsel, telephone 513-665-9770.
RULES RELATING TO PROOF OF MANUFACTURER
ACCEPTABLE PROOF
One of the following types of acceptable proof for an implant covered by Bristol, Baxter, or 3M must be attached to the Foreign Claim Form or have been previously provided to the Claims Office. (NOTE: THE COURT CAUTIONS AGAINST RELYING UPON PROOF OF MANUFACTURER PREVIOUSLY SUBMITTED TO THE CLAIMS OFFICE UNDER THE ORIGINAL GLOBAL SETTLEMENT AS IT MAY NOT SATISFY ANY OF THE ACCEPTABLE METHODS OF PROOF UNDER THE RSPF. THIS CAUTION IS PARTICULARLY IMPORTANT FOR CLAIMANTS WHO DO NOT SUBMIT FOREIGN CLAIM FORMS UNTIL 1999 SINCE CLAIMANTS MAY NOT LEARN FROM THE CLAIMS OFFICE OF DEFICIENCIES OR PROBLEMS WITH THE PROOF IN TIME TO FILE ACCEPTABLE PROOF BY THE FINAL DEADLINE OF JUNE 15, 1999.)
The Claims Office will continue to explore the possibility that other types of proof might be acceptable. If any such additional types are determined to be acceptable, this information will be available from the Claims Office and will be posted on the Court's webpage.
Acceptable Proof Based on Implantation Records
1. Hospital records of the implanting surgeon's report of the surgery--written at the time of the implantation surgery--that specify the brand name or manufacturer of the implants that were implanted.
2. A certified copy of medical records that contain the implant package label. Note: certification of the copy is only required if the label --
(A) is on a page that does not affirmatively reveal it to be a part of the participant's hospital or medical records; and
(B) does not have a lot number or serial number on it.
3. Implant labels clearly marked with lot or serial number. The Claims Office maintains a list of these numbers to ensure that no duplicates are used. These labels do not have to be certified.
4. Records of the implanting surgeon--written at the time of (or very shortly after) the implantation surgery--that specify the brand name or manufacturer of the implants that were implanted.
5. An affirmative statement from the implanting physician (or a responsible person at the treating facility where the implantation took place) attesting that the participant was implanted with a particular manufacturer's implants. The person making this affirmative statement must also provide the basis for that conclusion. This type of proof is acceptable only if the records described in #1 and #2 above are not available, and must include a description of what steps were taken to secure the types of proof outlined in #1 and #2 above and explain why those records were not available.
This type of proof is only acceptable for implantations occurring in the following countries where, according to the Settling Defendants, implants covered by the RSPF were distributed:
Argentina (only Bristol & 3M) | Mexico (only Bristol & 3M) | |
Australia | New Zealand (only Baxter & Bristol) | |
Brazil (only Bristol & 3M) | Norway | |
Canada | Pakistan (only Baxter & Bristol) | |
Chile (only Bristol) | Peru (only Bristol) | |
Columbia (only Bristol) | Phillipines (only Baxter & Bristol) | |
European Union counties | Saudi Arabia (only Baxter & Bristol) | |
Hong Kong (only Baxter & Bristol) | Singapore (only Baxter & Bristol) | |
Iceland (only Bristol) | South Africa | |
India | Switzerland | |
Iran (only Baxter) | Taiwan (only Bristol & 3M) | |
Israel (only Baxter & Bristol) | Thailand (only Baxter) | |
Japan | Turkey (only Baxter & Bristol) | |
Kenya (only Bristol) | Venezuela (only Bristol) | |
Korea (only Bristol & 3M) | Yugoslavia (only Bristol) | |
Lebanon (only Bristol) |
6. A health insurance claim form, signed by the implanting physician reasonably close to the date of the surgery, naming the type of implant used.
7. Manufacturer or brand-specific implant control sheets, with cross-reference to a specific patient, that reasonably appear to be contemporaneously-kept records in the hospital or implanting physician's office.
8. Manufacturer's invoice or packing list contained in claimant's medical or hospital records relating to the implant surgery. If the Claims Office cannot determine that the invoice or packing list actually was included in those records, a certified copy of the records or a supplemental statement from the records custodian may be required.
9. Manufacturer's catalog with a particular type of implant circled or otherwise marked, if contained in a certified copy of the participant's medical or hospital implantation records.
10. Warranties mentioning a particular type of breast implant, if contained in a certified copy of the participant's medical or hospital implantation records.
11. Surgitek's form "Patient Informed Consent - Gel Filled Mammary Implants" signed by the implant recipient and dated close to the date of the implantation surgery, accompanied by other contemporaneous medical or hospital records verifying that the implantation surgery actually occurred.
Note: although claim documentation not in the English language ordinarily must be translated into English and be accompanied by an appropriate statement from the translator (see paragraph 22 in the Notice), this translation and statement is not required for medical and hospital records offered as proof of manufacturer if, without any such translation, the Claims Office will be able to determine that the proof is acceptable under rules 1-4 or 6-11 above.
Acceptable Proof Based on Explantation Records
12. For explantations before January 1, 1996, contemporaneous medical records of the explanting physician specifically stating that an explanted breast implant is a "McGhan" or "3M". (In this limited instance, the physician does not have to state the basis for that conclusion. The statement identifying McGhan or 3M must, however, be a statement of fact and not merely an expression of opinion.) If the explantation record states that the removed implant is a McGhan, the implantation must have occurred before August 3, 1984.
13. Proof that an explanted breast implant had at least one of the following specific characteristics unique to the manufacturer's products--that characteristic being established either (A) in a contemporaneous medical record of the explanting physician (or other physician or appropriate professional who examined the implant during or after removal surgery) written at the time of the examination of the implant or (B) by a photograph of an explanted breast implant if the photograph is accompanied by a statement from the explanting physician identifying the breast implant in the photograph as one removed from the claimant:
Unique identifiers for Bristol implants are:
Unique identifiers for Baxter implants implanted before 3/31/84 are:
Unique identifiers for 3M implants are:
EXAMPLES OF UNACCEPTABLE PROOF