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SECTION 5 -SUBMITTING A CLAIM TO THE SILICONE MATERIAL CLAIMANTS FUND
Q5-1. "Why do I need to submit medical records or
documents that show I was implanted with an
eligible silicone gel breast
implant?"
To settle your claim you will need to submit
medical records or documents that show that you were implanted at any time after
January 1, 1976 and before January 1, 1992 with a silicone gel breast implant
made by Baxter, Bristol, Bioplasty, Cox-Uphoff (CUI), Mentor, Koken, Silimed,
Societe Prometel, or Medasil Surgical.
Q5-2. "How can I get a copy of my medical records
and documents to show who made my breast
implant?
Read through this Section and Tab 1, Part III
(1.3) carefully to understand the
medical records or documents you need to
obtain. Contact the doctor or hospital where your
breast implants were implanted and request a copy of your medical records. Those
records often list a brand name, catalog number, implant label, or other
identifying
information about the breast implant you received. You may need a "certified
copy" of
these medical records. Your doctor's office or hospital will know what this
means.
(Read Q5-11 for a definition of
certified copy.)
Compare the information in your medical records
with the information in this Section to see if it matches any of the criteria
for a silicone gel breast implant made by Baxter, Bioplasty, Bristol, Cox-Uphoff
(CUI), Mentor, Koken, Silimed, Societe Prometel, or Medasil Surgical.
Q5-3. "What medical records or documents can I
submit to show that my silicone gel breast implant
was made by Baxter, Bioplasty,
Bristol, Cox-Uphoff (CUI), Mentor, Koken, Silimed, Societe
Prometel, or Medasil
Surgical?"
There are many ways that you can show that your
silicone gel breast implant was made by Baxter, Bioplasty, Bristol, Cox-Uphoff
(CUI), Mentor, Koken, Silimed, Societe Prometel, or Medsasil Surgical. Anyone
(1) of the following are acceptable ways to do this provided that your records
establish that you are implanted with the eligible implant after January 1, 1976
and before January 1, 1992:
A. Hospital records of the surgeon's report of the
surgery -written at or near the time of the implantation
surgery -that specify
one (1) of the eligible brand names or list an eligible implant manufacturer.
B. A certified copy of your medical records that
contains the date of implantation and the implant
package label demonstrating
one (1) of the eligible breast implants as listed at
Tab 1, Part III.
Note: a certified copy is required only
if:
1. The
label is on a page that does not affirmatively reveal it to be a part of your
hospital or medical
records and does not have a lot number, serial number, or
catalog number on it; or
2.
The hospital records are organized so that the implant label/sticker was put on
a page by itself. If
the page containing the implant label/sticker clearly
comes from the hospital's contemporaneous
record of the implant surgery, has other information
relating to the claimant's hospitalization on
that page, and has sufficient patient identification for the
Settlement Facility to tell that it came
from your records, it falls into the acceptable proof
category of contemporaneous hospital
records, and does not have to be certified.
C.
Implant labels clearly marked with a lot, serial or catalog number and which
shows the date of
implantation after January 1, 1976 and before January 1, 1992.
The Settlement Facility will
maintain a list of these lot, serial and catalog
numbers, to ensure that no duplicates are used. These
labels do not have to be
certified.
D.
Records of the implanting surgeon -written at the time of the implantation
surgery after January 1,
1976 and before January 1, 1992 -that specify one (1)
of the eligible brand names or list an
eligible implant manufacturer.
E. An
affirmative statement from the implanting physician (or a responsible person at
the treating
facility where the implantation took place) attesting that you were
implanted with an eligible silicone
gel breast implant along with proof that you
were implanted with that breast implant after
January 1, 1976 and before January
1, 1992. The person making this affirmative statement must
also provide the
basis for that conclusion. This type of proof is acceptable only if the records
outlined in paragraphs A and B above are not available, and must include a
description of what
steps were taken to secure the types of proof outlined in
paragraphs A and B above and explain
why those records were not available. The
statement of steps taken can be provided by your
attorney. This statement cannot
rest upon unacceptable proof as listed in Q5-9.
F. A health insurance claim form, signed by your
implanting physician reasonably close to the date of
the surgery, naming the
type of implant used as listed above. The health insurance form should
show that
your eligible silicone gel breast implant was implanted after January 1, 1976
and before
January 1, 1992.
G.
Medical records of the explanting physician (or other physician or appropriate
professional who
examined your implant during or after removal surgery) -
written at the time of the examination of
the breast implant -if that physician
or other appropriate professional points out a specific
characteristic of the
breast implant that is on the list of characteristics unique to Baxter, Bioplasty,
Bristol, Cox-Uphoff (CUI), Mentor, Koken, Silimed, Societe Prometel
or Medasil Surgical
implants as listed in Q5-7. You must still provide a
statement or other records to establish that
your eligible silicone gel breast
implant was implanted after January 1, 1976 and before
January 1, 1992.
H.
A
photograph of an explanted breast implant that shows one (1) of the
characteristics unique to an
eligible silicone gel breast implant, as listed in
Q5-7, if the photograph is accompanied by a
statement from the explanting
physician identifying the breast implant in the photograph as one
(s)he removed
from you. You must still provide a statement or other records to establish that
your
eligible silicone gel breast implant was implanted after January 1, 1976
and before
January 1, 1992.
I.
Brand-specific implant control sheets, with cross-references to you, that
reasonably appear to be
contemporaneously kept records in the hospital or
implanting physician's office. You must still
provide a statement or other
records to establish that your eligible silicone gel breast implant was
implanted after January 1, 1976 and before January 1, 1992.
J.
An
invoice or packing list from either Baxter, Bioplasty, Bristol, Cox-Uphoff
(CUI), Mentor,
Koken, Silimed, Societe Prometel or Medasil Surgical contained in
your medical or hospital
records relating to the implant surgery. If the
Settlement Facility cannot determine that the invoice
or packing list actually
was included in those records, they may require a certified copy of the
records
or a supplemental statement from the records custodian. You must still provide a
statement or other records to establish that your eligible silicone gel breast
implant was implanted
after January 1, 1976 and before January 1, 1992.
K. A
catalog from Baxter, Bioplasty, Bristol, Cox-Uphoff, Mentor, Koken, Silimed,
Societe
Prometel or Medasil Surgical with a particular type or style of implant
circled or otherwise
marked, if contained in a certified copy of your medical or
hospital records relating to the implant
surgery after January 1, 1976 and
before January 1, 1992 which were compiled and/or produced
before or about the
time of that surgery.
L.
Patient Informed Consent forms signed by you and dated close to the date of the
implantation
surgery after January 1, 1976 and before January 1, 1992,
accompanied by other
contemporaneous medical or hospital records verifying that
the implantation surgery actually
occurred and identifying an eligible silicone
gel breast implant as the manufacturer.
M.
Admissions in pleadings or letters written by Baxter, Bioplasty, Bristol, Cox-Uphoff,
Mentor,
Koken, Silimed, Societe Prometel or Medasil Surgical to you, your
representative or your
physician acknowledging that your breast implants were
manufactured by them. You must still
provide a statement or other records to
establish that your eligible silicone gel breast implant was
implanted after
January 1, 1976 and before January 1, 1992.
N.
Warranties mentioning a breast implant brand listed at
Tab 1, Part III as being
a covered implant,
if the warranty is contained in a certified copy of your
medical or hospital records.
O.
Written acceptance of your implant manufacturer from either Baxter, Bioplasty,
Bristol, Cox-
Uphoff (CUI), Mentor, Koken, Silimed, Societe Prometel, or Medasil
Surgical (as appropriate to
your type of implant).
Q5-4. "What brand names are acceptable?"
A complete list of acceptable brand names is in
Tab 1, Part III.
Q5-5. "Are there other words or references I may
look for in my medical records to show that my
silicone gel breast implant was made
by one (1) of the eligible
manufacturers?"
Yes. You can look for "Unique Identifiers"
described in Q5-6 and Q5-7 or for lot or catalog numbers as
described in
Q5-8.
Q5-6. "What are the "Unique Identifiers?"
Unique Identifiers are a list of features or
characteristics that are unique to breast implants made by each
company. If your
breast implants are removed and examined by the physician who removed them or
other physician or appropriate professional and (s)he points out specific
characteristics of the breast
implant that are on the list below in
Q5-7, then
this is acceptable proof.
Q5- 7. "What "Unique Identifiers" are acceptable?"
For Bristol the unique identifiers are:
A. Polyurethane for implantations before September
1, 1971 and after December 8, 1978.
B. Bilumen implants described as having a standard
gel implant within, but not attached to, an outer
inflatable elastomer shell.
C. An implant having an SSI valve. An SSI valve
can be mentioned by name, or by description; a
circular valve that looks like a
button, having a slightly rounded dome. It is dacron-mesh reinforced.
D. An implant having a Ouin-Seal valve. This valve
is flat and its entry site is marked with a white dot.
E. An adjustable reconstructive implant with two
puncture seal sites (shell and column).
F. An implant with "SCL" molded on the shell. G.
An implant with radiopaque size markers.
H. For implantations before September 1, 1971 or
after December 8, 1978, an
implant shell exhibiting
roughness due to adhesive can be treated as a
"polyurethane" implant even if the foam cover is
gone.
I. An implant with a "Y-shaped septum."
For Baxter the unique identifiers are:
A. Polyurethane for implantations from September
1, 1971 to December 8, 1978.
B. For implantations September 1, 1971 to December
8, 1978, an implant shell exhibiting roughness
due to adhesive can be treated as
a "polyurethane" implant even if the foam cover is gone.
C. An implant with horizontal thin silicone tubing
approximately 1 mm in diameter. The tubing lies from
edge to edge of patch for
orientation purposes. Ends of tubing are "RTV" closed.
D. An implant with a butterfly silicone fixation
patch which is perforated to allow tissue ingrowth. The
edges of the patch, but
not the face, are adhesed to the main patch.
E. An implant with a molded or cast number
composed of a single letter A, B, or C and followed by a
single-digit number.
F. An implant with a "spiral" or "target"
imprinted design composed of concentric rings located on the
main patch.
G. An implant with a retention valve positioned at
an acute angle to flange.
H. An implant with a diagraph (Jenny) valve placed
on the anterior face of the implant.
(On round styles, valve will be at the apex
of the anterior face.)
Note: Baxter identifiers C-H above related
only to implantations before March 31,
1984.
Q5-8. "What are the lot and catalog numbers?"
Breast implant manufacturers used catalog numbers in sales brochures and breast implant package
materials. These numbers were
sometimes written down in a patient's medical records and can be used
to
identify the breast implants. The lot numbers are different numbers that
identify when the implants
were made. Call the Claims Assistance Program Toll
Free at 1-866-874-6099 to ask about the lot or
catalog numbers listed in your medical records.
Q5-9. "What medical records and documents are
unacceptable as proof of manufacturer?"
Examples of unacceptable proof include:
1. Your own recollection (or that of a friend or a relative) regarding the brand
name
or manufacturer of
your breast implants.
2. Records from the International Implant
Registry.
3. Identifying reports from a physician who
examined your breast implants during or
after removal
surgery, if identifiers not on the list of Unique Identifiers are
the basis of the identification, or the
physician fails to specify the
characteristics assumed to be unique, or the physician merely opines,
based on
his or her experience, that the breast implant was made by a certain
manufacturer.
4. A non-contemporaneous statement by the
implanting physician, attempting to supply the acceptable
proof listed in the
Proof of Manufacturer Form Instructions but qualifying the affirmative statement
concerning the type of implant used in a particular patient by phrases like "if
I remember correctly"
or "to the best of my memory." Statements from medical
personnel describing their typical or general
practices concerning implant usage
during a given time period will be unacceptable proof.
5. A non-contemporaneous statement by your
implanting physician, attempting to provide the
acceptable proof that does not
name you as a person receiving a particular type or brand of implant
will be
treated as unacceptable proof.
6. Records indicating the brand or manufacturer of
implants the surgeon planned to use, without
confirmation from the implanting
physician (or in records relating to the implant surgery) that type of
implant
was actually used.
Q5-10. "What types of problems or deficiencies are
there for proof of manufacturer?"
Several minor deficiencies may be found in proof
that would otherwise be acceptable. These minor
deficiencies include:
1. You submit acceptable proof but do not submit a
Claim Form. It is necessary to submit the
completed and signed Claim Form.
2. You fail to provide a certified
copy of
medical records for acceptable proof.
3. An affirmative statement from the implanting
physician has been submitted, but the physician failed
to provide the basis for
his/her conclusion that you received a certain brand of implants. (S)he must
write a statement explaining why (s)he believes you received a certain brand of
implants.
4. Medical records have been submitted, but there
is no identification on the records themselves
indicating that these records
relate to you. You will need to obtain a certified copy of the medical
records from your implanting physician's office or hospital verifying that the
medical records are
yours.
5. The Settlement Facility needs confirmation that
the statement or proof you submit came from the
physician or someone on the
treating facility or physician's staff.
6. The proof you submit has contradictory evidence
of the brand of implant you received. For
example, the operative report lists
one brand, but you submitted a label of another brand, and both
types of proof
refer to the same surgery.
7. You submit a photograph of a breast implant
showing one (1) of the Unique Identifiers but you do
not provide a statement
from the explanting physician identifying the implant in the photograph as
the
one he/she removed from you. You need to obtain this statement from the
physician.
CLAIM FORM
INSTRUCTIONS
SILICONE MATERIAL CLAIMANTS AND
PARTICIPATING
FOREIGN GEL CLAIMANTS (CLASS 7)
For your convenience are questions and answers taken from the Silicone Material Claimants' Fund
(Class 7).
Please read these Instructions and the Claimant Information Guide for more
information.
1. "What is the Silicone Gel Material Claimants Fund?
(Class 7)?"
The Silicone Material Claimants' Fund is a fund of $57.5 million (Net Present
Value) set aside to make
Expedited Release or Disease Payments to women
who were implanted with certain types of silicone gel
breast implants from 1976-1991. To be
eligible, you must have been implanted with a silicone gel breast
implant made by one (1) of the manufacturers
listed in Question 2. You are not eligible if you were ever
implanted with a Dow Corning implant. If you were
ever implanted with a Dow Corning implant, do not
complete this form. Call the Settlement Facility
Toll Free at 1-866-874-6099 to obtain the correct claim
forms.
2. "What silicone gel breast implants qualify for
settlement benefits?"
Review the chart below to see if you received a silicone gel breast implant from
one (1) of the following
manufacturers. (Read Section 5 in the Claimant
Information Guide for more information.)
|
A. If you have a silicone gel breast
implant implanted from 1976-1991
from one (1) of the following, you
are a Silicone Material Claimant.
|
B.
If you have a silicone gel breast
implant implanted from 1976-1991
you are a from any of the following,
Participating Foreign Gel Claimant.
|
|
Bioplasty |
Koken |
|
Baxter |
Medasil |
|
Bristol |
Silimed |
|
Cox Uphoff or CUI |
Societe Prometel |
|
Mentor |
-------- |
3. "What do I need to submit to show who made my
silicone gel breast implants?"
The criteria to show who made your breast implant are the same criteria used in
the Revised Settlement
Program (RSP). If your implant proof in the
RSP was acceptable for a silicone gel breast implant, then you
will not need to submit any additional
documents (as long as your records show your eligible silicone gel
breast implant was implanted from
1976-1991). (The criteria to establish your implant manufacturer
are set out in Section 5 of the Claimant
Information Guide.)
4. "What are the settlement options for silicone material claimants?"
Silicone Material Claimants can receive payment for:
A. Expediated Release Payment. You can receive payment simply
by showing that you were implanted
from 1976 -1991
with one (1) of the silicone gel breast implants in column A in Question 2
above.
or
B. Disease Payment. You can receive payment for one (1) of the nine (9)
eligible diseases and conditions if
you submit
medical records and documents that show that you have one (1) of the diseases or
conditions
listed in
Question 6 below and you have a related disability or meet the severity
criteria for that disease
or condition.
5. "How much is the Expedited Release Payment?" (Note:
This payment is available only to silicone
material claimants.)
There is no set payment amount for the Expedited Release Payment. After all
claims have been submitted to
the Silicone Material Claimants' Fund, the Claims
Administrator will determine the amount of the Expedited
Release Payment.
6. "What is the disease payment?" (Note: This payment
is available only to silicone material
claimants.)
The Disease Payment provides payment if you submit medical records and documents
that show that you
have one (1) of the diseases or conditions listed
below and you have a related disability or meet the severity
criteria for that disease or condition.
There are nine (9) eligible diseases and
conditions in Disease Options 1 and 2. The eligible diseases and
conditions are:
1. Atypical Connective Tissue Disease (ACTD)
2.
Atypical Neurological Disease Syndrome (ANDS)
3. Primary Sjogren's
Syndrome (PSS)
4.
Mixed Connective Tissue Disease (MCTD)/ Overlap
Syndrome
5. Systemic Sclerosis /
Scleroderma (SS)
6. Systemic Lupus
Erythematosus (SLE)
7. Polymyositis (PM)
8. Dermatomyositis (DM)
9. General Connective Tissue Symptoms (GCTS)
(Read Section 7 in the Claimant Information Guide for more information about
the Disease Payment.)
7. "How much is the Disease Payment?"
The payment grid is listed at Question Q2-4 in the Claimant Information Guide.
The amount of the Disease
Payment depends on several things: .
1. The number of approved disease and expedited release claims; and
2. Whether you have received or are eligible to receive payment from your
implant manufacturer
(i.e., this is called
"marshaling"). (Read Section 12 in the Claimant Information Guide for more
information
on marshaling.)
8.
"What do I need to do to receive payment as a Silicone Material Claimant?"
Follow steps 1-4 below:
1. Complete and return the claim form by the deadline in Question 14; and
2. Send in medical records or documents that show that you were implanted with a
silicone gel breast
implant from
Baxter, Bioplasty, Bristol, Cox-Uphoff (CUI), or Mentor. (Read Section 5 in the
Claimant
Information Guide
for a list of implant specific brand names, "Unique Identifiers" and other
information
associated with
these breast implants.); and
3. Send in medical records or documents that show that your eligible silicone
gel breast implant was
implanted after
January 1, 1976 and before January 1, 1992; and
4. If you are applying for an Expedited Release Payment, check Box 7 A and sign
and return the claim
form. If you are
applying for a Disease Payment, check Box 7B and complete the rest of the claim
form.
Send in the
necessary medical records to support the disease and disability or severity you
claim.
9. "What are the settlement options for Participating
Foreign Gel Claimants?"
You are eligible to receive a payment if there is excess money in the Silicone
Material Claimants' Fund after
all approved Silicone Material Claimants have
been paid. You are not eligible for the Expedited Release or
Disease Payment.
10. "What do I need to do to qualify as a Participating
Foreign Gel Claimant?"
Follow steps 1-4 below:
1. Complete and return the claim form by the deadline in Question 14; and
2. Send in medical records or documents that show that you were implanted with a
silicone gel breast
implant from
Koken, Medasil, Silimed, or Societe Promotel. (Read the Claimant Information
Guide for
more
information.); and
3. Send in medical records or documents that show that your eligible silicone
gel breast implant was
implanted
after January 1, 1976 and before January 1, 1992; and
4. Check Box 2B on the claim form stating that you are a Participating Foreign
Gel Claimant. Sign and
return the
claim form. Do not answer any other questions on the form.
11. "Are Explant and Rupture payments available to
Silicone Material Claimants or Participating
Foreign Gel Claimants?"
No.
12. "Can I use the medical records that I have already sent to the MDL Claims
Office to support my
claim?"
Yes. You do not have to resubmit the same medical records or documents. You
must. however. complete
and return this form.
13. "Question 6 on the claim form asks whether I have
received or am eligible to receive payment
from certain implant manufacturers.
Why is this information necessary?"
If you received
any payment(s) from Baxter, Bristol, 3M, Koken, Medasil, Silimed or Societe
Prometel for
your silicone gel breast implant(s), then your Expedited Release or
Disease Payment will be reduced by the
amount of that prior payment. If you
received a substantial payment from your implant manufacturer, it is
possible
that you will not recover any payment from the Silicone Material Claimants'
Fund. (Read Section
12 in the Claimant Information Guide for more information.)
14. "What is the Deadline to
submit a Claim Form and Supporting Documents?"
You must return this claim form with supporting documents on or before two
(2) years after the Effective
Date.
15. "Can I submit my claim form and documents in a
language other than English?"
If your medical records are in one (1) of the languages listed below, then you
may submit your claim form
and documents in that language. You
do not have to translate your documents to English. However, if your
documents are in a language other
than one listed below, then you must translate your documents to
English. (Read Question Q2-10 in the
Claimant Information Guide.)
You may submit documents in any of the following languages:
Dutch Portuguese French
Spanish German Swedish
Korean Vietnamese
16. "Who can I contact if I have a question or need
help?"
The Claims Assistance Program is available to answer questions about the
Silicone Material Claimants'
Fund. There is no charge to you for
this service.
SILICONE MATERIAL CLAIMANTS:
LIST OF MANUFACTURERS
|
Brand /
Manufacturer Name |
Status in
Revised Settlement |
|
3M |
3M |
|
AHS |
Baxter |
|
Aesthetech |
Bristol |
|
American Heyer Schulte |
Baxter |
|
American Hospital Supply |
Baxter |
|
Ashley:
Implanted before 9/1/71
Implanted 9/1/71 to 12/8/78
Implanted after 12/8/78
|
Bristol
Baxter
Bristol
|
|
Baxter |
Baxter |
|
Becker |
Mentor |
|
Biomanufacturing |
Bioplasty |
|
Bio-oncotic |
Bioplasty |
|
Bioplasty |
Bioplasty |
|
Birnbaum |
Baxter |
|
Capozzi:
Implanted before 9/1/71
Implanted after 8/31/71 |
Bristol
Baxter
|
|
Cavon |
Bristol |
|
CBI Medical |
Bristol |
|
Cooper Surgical |
Bristol |
|
Corbet |
Bristol |
|
Cox Uphoff |
CUI |
|
CZV/CRS (Croissant Versafil Low Profile) |
CUI |
|
Dahl |
Bristol |
|
Directa Span |
Mentor |
|
DRI |
CUI |
|
DRIE |
CUI |
|
Edward Laboratories |
Baxter |
|
EHP (Enhanced High Profile) |
CUI |
|
Edward Weck & Co.
Implanted before 9/1/71
Implanted 9/1/71 to 12/8/78
Implanted after 12/8/78
|
Bristol
Baxter
Bristol
|
|
Flat Span |
Mentor |
|
FZV/SFV (Round Versafil LP Tissue
Expander) |
CUI |
|
Georgiade |
Bristol |
|
Gibney |
CUI |
|
Guthriez:
Implanted before 9/1/71
Implanted 9/1/71 to 12/8/78
Implanted after 12/8/78
|
Bristol
Baxter
Bristol
|
|
Hartley |
Baxter |
|
Heyer-Schulte
Implanted before 3/31/84
Implanted after 3/30/84 |
Baxter
*Mentor
|
|
Heyer-Schulte Mentor |
Mentor |
|
Intrashiel:
Inplanted before 8/3/84
|
3M
|
|
Intravent |
CUI |
|
IOC (Cylindrical Intraoperative Tissue
Expander) |
CUI |
|
IOM (Intravent Intraoperative Expander) |
CUI |
|
IOS (Spherical Intraoperative Tissue
Expander) |
CUI |
|
Isle |
Mentor |
|
Jenny |
Baxter |
|
Jobe |
Baxter |
|
Klein |
Bioplasty |
|
Mammatech |
Bioplasty |
|
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
|
|
McGhan
Implanted before 8/3/84
|
3M
|
|
MEC |
Bristol |
|
Medical Engineering Corporation |
Bristol |
|
Meme |
Bristol |
|
Meme ME |
Bristol |
|
Meme MP |
Bristol |
|
Mentor |
Mentor |
|
MFE (Man Facelift Expander) |
CUI |
|
Microcell |
CUI |
|
Misty |
Bioplasty |
|
Misty Gold |
Bioplasty |
|
Mueller, V.
Implanted 11/1/78 to 3/30/84 |
Baxter
|
|
Munna |
Bristol |
|
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
|
|
Norman |
Bristol |
|
OHP (Oval High Profile) |
CUI |
|
OLP (Oval Low Profile) |
CUI |
|
Optimam |
Bristol |
|
Pangman |
Baxter |
|
Papillon |
Bristol |
|
Perras |
Bristol |
|
Perras-Papillon |
Bristol |
|
Polyurethane:
Implanted before 9/1/71
Implanted 9/1/71 to 12/8/78
Implanted after 12/8/78
|
Bristol
Baxter
Bristol
|
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Poly Plastic:
Implanted before 9/1/71
Implanted after 8/31/71
|
Bristol
Baxter
|
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Poly Plastic Adjustable |
Baxter |
|
Quin-Seal |
Bristol |
|
Radovan |
Mentor |
|
RCP (Round Conical Profile) |
CUI |
|
RCR (Ruiz-Cohen Expanders) |
CUI |
|
RDD (Reverse Double Lumen DRIE) |
CUI |
|
RDL (Reverse Double Lumen) |
CUI |
|
RDL-XPAND |
CUI |
|
RDX (Round Double Lumen) |
CUI |
|
Replicon |
Bristol |
|
Reverse Double Lumen |
CUI |
|
RHD (Round High Profile) |
CUI |
|
RHP (Round High Profile) |
CUI |
|
RLD (Round Low Profile DRIE) |
CUI |
|
RLP (Round Low Profile) |
CUI |
|
Roger Klein |
Bioplasty |
|
RTV/RTT (Smooth/Textured) |
CUI |
|
Ruiz-Cohen |
CUI |
|
RZV/SRV (Rectangular Versafil Tissue
Explander) |
CUI |
|
SCC (Cylindrical Tissue Expander) |
CUI |
|
SCL |
Bristol |
|
SCS (Crescent Tissue Expander) |
CUI |
|
SEE (Mini-Crescent Tissue Expander |
CUI |
|
Seropian |
Baxter |
|
SFS (Saline Fill Skin and Tissue
Expander) |
CUI |
|
SGO (Saline Gel Oval) |
CUI |
|
SGR (Saline Gel Round) |
CUI |
|
Siltex |
Mentor |
|
Siltex Becker |
Mentor |
|
Siltex Spectrum |
Mentor |
|
SLP (Single Lumen Adjustable) |
CUI |
|
SLS (Longitudinally Curved Tissue
Expander) |
CUI |
|
Snyder |
Bristol |
|
SOE (Small Oval Tissue Expander) |
CUI |
|
SOS (Ear Shaped Tissue Expander) |
CUI |
|
Spectrum |
Mentor |
|
SPS (Pear Shaped Tissue Expander) |
CUI |
|
SRS (Rectangular Tissue Expander) |
CUI |
|
SSS (Spherical Tissue Expander) |
CUI |
|
Sterling |
Baxter |
|
Summit Medical |
Bristol |
|
Surgical Specialties |
Bristol |
|
Surgitek |
Bristol |
|
SWS (Wedge Shaped Tissue Expander) |
CUI |
|
SZR (Round Low Profile Sizer) |
CUI |
|
Tabari |
Baxter |
|
Tecknar |
Mentor |
|
TLL (Triple Lumen Round) |
CUI |
|
Travenol |
Baxter |
|
Tri-Lumen |
CUI |
|
TRL (Tri-Lumen Implants) |
CUI |
|
TSO (Triple Lumen Low Profile Oval) |
CUI |
|
TSR (Triple Lumen Round Low Profile) |
CUI |
|
Uroplasty |
Bioplasty |
|
Versafil |
CUI |
|
V. Mueller
Implanted 11/1/78 to 3/30/84
|
Baxter
|
|
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
|
|
Williams |
Baxter |
|
Wood |
Bristol |
|
Note: Implants noted as Mentor that have a star (*) before Mentor
will be treated as Baxter
implants if a Baxter lot
number can be supplied for that implant.
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