Lawyer's and Attorney's for Breast Implants-Dow Implant Proof

Hummer Law Office: Attorney for Breast Implants located in Pinellas County, Florida USA

"ACCEPTABLE PROOF", "UNACCEPTABLE PROOF", AND "DEFICIENCIES"
Note: This information has been reprinted from the Dow Corning Claimant Information Guide (Class 5)

ACCEPTABLE PROOF

You can submit any of the following medical records or documents listed below in paragraphs A-Q:

    A. Hospital records of the surgeon's report of the breast implant surgery-written at or near
        the time of the implant surgery-that specify a Dow Corning brand name or Dow Corning
        as the manufacturer. Directly below is a list of acceptable brand names of breast
        implants manufactured by Dow Corning.

BRAND NAME	STATUS
Cronin	Acceptable if your breast implants were implanted in or from 1963-1971
Dow Corning	Acceptable
Dow Corning Wright	Acceptable
DC or DCW	Acceptable
Mueller, V. or V. Mueller	Acceptable if your breast implants were implanted after January 1, 1968 and before August 31, 1974
SILASTIC or Silastic	Acceptable
SILASTIC II or Silastic II	Acceptable
SILASTIC MSI or Silastic MSI	Acceptable
"silastic" in all lower case letters	Acceptable if it is contained in a contemporaneous operative report for a breast implantation prior to 1969, provided that there is no other information in your records that is inconsistent with a Dow Corning product. This type of proof shall be used only if you do not have any explant records demonstrating a "Unique Identifier."
Varifil	Acceptable

B. A "certified copy" of your medical records that contains the breast implant package label
     demonstrating a Dow Corning breast implant. (A certified copy is a copy of records with a
     certificate attached, usually signed by the custodian of records for that office or facility,
     affirming that the attached pages are true and accurate copies of records in a particular
     patient's file. Note: a certified copy is required only if

1. The label is on a page that does not affirmatively reveal it to be part of your hospital or
medical records and does not have a lot number, serial number, or catalog number.

     2. The hospital records are organized so that the breast implant label/sticker was put on a
         page by itself. If the page containing the breast implant label/sticker clearly comes
         from the hospital's contemporaneous record of the breast implant surgery, has other
         information relating to your 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. Breast implant labels clearly marked with a Lot, serial or catalog number.
     (Read Question Q5-9 in the Claimant Information Guide for information about lot,
     serial and catalog numbers of Dow Corning breast implants.) These labels do not have to
     be certified.

D. Medical records from your implanting surgeon -written at the time of your breast implant
surgery -that specify a Dow Corning brand name or Dow Corning as the manufacturer.
The list of Dow Corning brand names is at Question 5 below.

E. An affirmative statement from your implanting physician (or a responsible person at the
    treating facility where your breast implant surgery took place) attesting that you were
    implanted with a Dow Corning breast implant. The person making this affirmative
    statement must also provide the basis for that conclusion. This type of proof is acceptable
    only if:

1. The records outlined in subparagraphs 3A and 3B above are not available; and

2. It must include a description of what steps were taken to try to secure the types of proof
outlined in subparagraphs 3A and 3B above; and

    3. It must explain why those records were not available. The statement of steps taken can
        be provided by your attorney if you are represented by counsel. This statement cannot
        rest upon "unacceptable proof" as defined in Question Q5-11 in the Claimant
        Information Guide.

F. A health insurance claim form, signed by your implanting physician reasonably close to the
date of the breast implant surgery, naming the type of breast implant used.

G. Medical records of the physician who removed your breast implant (or other physician or
     appropriate professional who examined your breast implant during or after removal
     surgery) -written at the time of the examination of your breast implant -if that physician or
     other appropriate professional points out a specific characteristic of the breast implant
     that is on the list of "Unique Identifiers" for Dow Corning breast implants. The list of
     "Unique Identifiers" for Dow Corning breast implants is at Question Q5-8 in the Claimant
     Information Guide.

H. A photograph of your removed breast implant that shows one (1) of the "Unique
Identifiers" for a Dow Corning breast implant, as listed in Question Q5-8 in the Claimant
Information Guide, it

1. The photograph is accompanied by a statement from the physician who removed your
breast implant; and

2. (S)he identifies the breast implant in the photograph as one (s)he removed from you.

I. Dow Corning or 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. (Read Question Q5-10 in the Claimant Information Guide for a
    description of "control sheets. ")

J. Dow Corning's invoice or packing list contained in your medical or hospital records relating
    to the breast 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.

K. Dow Corning's catalog with a particular type or style of breast implant circled or
     other-wise marked, if contained in a "certified copy" of your medical or hospital records
     relating to the implant surgery, 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 your breast
     implant surgery, accompanied by other contemporaneous medical or hospital records
     verifying that the breast implant surgery actually occurred and identifying Dow Corning as
     the manufacturer of the breast implant.

M. Admissions in pleadings or letters written by Dow Corning to you, your representative or
your physician acknowledging that your breast implants were manufactured by Dow
Corning.

N. For breast implants implanted after July 1986, participation in Dow Corning's "Product
     Replacement Expense Program" ("PREP") as documented by a signed PREP brochure,
     statement, or similar document if contained in a "certified copy" of your contemporaneous
     medical or hospital records.

O. Participation in Dow Corning's "Removal Assistance Program" after March 1992
     documented by correspondence enclosing payment for uninsured medical expenses issued
     under the program based on receipt of proper documentation. Dow Corning will I provide
     the names of persons it can document that participated in the Removal Assistance
     Program. If you are identified by Dow Corning as having participated in the Removal
     Assistance Program, the Settlement Facility will inform you of this, and you will not need
     to submit additional proof of manufacturer documents.

UNACCEPTABLE PROOF

Q5-4 "Are there brands that are not acceptable proof of a Dow Corning breast implant?"

I Yes. The following types of references in medical records or documents are not
acceptable proof:

1. Your medical records say "silastic-type" in all lower-case letters and do not have
any other identifying information.

2. Your medical records say "silastic" in all lower-case letters and the implants were
implanted after 1969.

3. Your medical records say "Cronin" and show that the implants were implanted in
1972 or later.

4. Your medical records or proof say "Mueller, V. or V. Mueller" and show that the
implants were implanted prior to 1968 or after August 31, 1974.

           5. Your medical records or proof refer to brands or names other than those listed at
               Question 5 in the Proof of Manufacturer Form Instructions or those listed at Tab 1,
             Part I for Dow Corning breast implants.

Q5-6 "Are there other words or references I may look for in my medical records to show that
my breast implant was made by Dow Corning?

Yes. You can look for "Unique Identifiers" described in 05-7 and 05-8 or for lot or
catalog numbers as described in 05-9.

Below is information regarding "Unique Identifiers" that may be helpful in identifying your implants as a Dow product. Occasionally, plastic surgeons make mention of these identifiers in operative reports. Also, a pathologist will sometimes make mention of a "Unique Identifier" in their report. Finally, there are specialists available that can, in most cases, identify the manufacturer. Click here to learn more about this.

Q5- 7 "What are the "Unique Identifiers" for Dow Corning breast implants? Are they
acceptable proof that Dow Corning manufactured the breast implant?

          Unique Identifiers are a list of features or characteristics that are unique to Dow
          Corning breast implants. If your breast implants are removed and examined by
          the explanting physician or other physician or appropriate professional and
          (s)he points out specific characteristics of the breast implant that are on the list
          below in 05-8, then this is acceptable proof that you had a Dow Corning breast
          implant.

Q5-8. "What "Unique Identifiers" are acceptable proof of a Dow Corning breast implant?"

The following Unique Identifiers of a Dow Corning breast implant shall be considered as acceptable proof where the removed implants are examined by a physician who identifies the manufacturer or brand:

1. For implantations or implants manufactured between 1969 and 1973 a high profile contour
    "ski slope" design implant with Dacron@ fixation patches on the posterior with the upper
    portion of the implant being concave and the bottom portion convex. If the fixation patch
    has detached from the implant, then the Settlement Facility shall accept and shall deem as
    acceptable proof a photograph of the implant showing an imprint consisting of 3-4 linear
    impressions of the Dacron@ mesh embedded in the elastomer shell.

2. An implant with fixation patches where white Dacron@ knit mesh loops were either sewn
    or bonded to the elastomer patch surface with the fixation patches in turn bonded to the
    envelope posterior. Products with the following configurations of fixation patches are
    acceptable:

    (i)   For implants implanted or manufactured between 1963 and 1965, a single large
          Dacron@ mesh-reinforced fixation patch covering all or almost all of the posterior
          implant surface of a silicone gel-filled implant with a prominent non-everted peripheral
          seam where the fixation patch is constructed of Dacron@ mesh-reinforced silicone
          elastomer sheeting to which non-embedded Dacron@ mesh had been sewn with
          Dacron@ sutures (1963-1965).

    (ii) For implants implanted or manufactured between 1963 and 1969, four (4) Dacron@
          mesh-reinforced fixation patches, one (1) in each quadrant on the posterior implant
          shell, asymmetric or symmetric, with a distinct peripheral seam everted or non-everted,
          where the fixation patches are constructed of Dacron@ mesh-reinforced silicone
          elastomer sheeting to which non-embedded Dacron@ mesh has been sewn with
          Dacron@ sutures.

   (iii) For implants implanted or manufactured between 1968 and 1982, two (2) to five (5)
          circular Dacron@ mesh fixation patches on the posterior implant shell of the
          embedded/pleated design, consisting of a clear elastomer disc about 22-25mm diameter,
          with a pattern of embedded Dacron@ mesh in a pleated pattern, with the actual
          Dacron@ mesh present or absent.

   (iv) For implants implanted or manufactured between 1968 and 1976, a dumbbell-shaped
          Dacron@ mesh-reinforced fixation patch on the posterior implant shell, together with
          one (1), three (3), or four (4) additional round fixation patches on the implant shell.
          Internal to the dumbbell- shaped fixation patch are either two (2) round shell holes
          (one larger than the other) separated by a slit in the shell, or a single round shell hole.

3. For implants implanted or manufactured between 1971 and 1975, an eccentrically placed
    racetrack (oval) shaped posterior shell patch, Dacron@ mesh-reinforced, outside the
    implant shell. Internal to the patch are either two (2) round shell holes (one larger than the
    other) separated by a slit in the shell, or a single round shell hole.

4. A leaflet valve consisting of a proximal round part, attached to which is a distally rounded
    leaflet valve. The junction of the proximal and distal parts of the valve is also rounded
    (flared). (This identifier applies to saline implants implanted or manufactured between
    1979-1984; and to gel/saline implanted between 1981-1992.)

5. An implant having one (1) of the following as an imprinted logo on the posterior
(for double-lumen implants such markings are only present on the inner lumen patch):

(i) DOW CORNING (1978 to 1992)

(ii) SILASTIC II (1981 to 1992)

(iii) DOW CORNING WRIGHT (1989 to 1992)

6. An implant with both:

    (a) Mandrel Code and
    (b) Designation Number imprinted together on the posterior centered or near the patch of
         the implant envelope. These shell markings consist of a single letter or one (1) or two
         (2) numerals approximately 4mm height with a close-by series of three (3) or four (4)
         approximately 2mm height numerals. For double-lumen implants such markings will be
         on both shells. The following Mandrel Codes and Designation Numbers are acceptable:

(i) Mandrel Codes (numbers 1-16, 20, 30, 40, 50, 60 or single uppercase letters A-R)
(1969 to 1992); and

         (ii) Mandrel Designation Numbers three (3), or rarely four (4), digit numbers where the
              characters are between 1/16 inch and 5/64 inch, 1.5 mm to 2.0 mm in height
              (1974 to 1992).

7. An implant with a 1.7 inch-long orientation bar (a linear raised strip of elastomer
permanently bonded to the posterior of the shell of contour shaped implants) aligned with
the long axis of the implant (1975 to 1986).

8. An implant (SILASTIC@ MSI) with a surface covered by tiny micro pillars (1989 to 1992).

Q5-9. What are the lot and catalog numbers for Dow Corning that are mentioned in 05-6?

Implant catalog numbers were listed in sales and other brochures, In general, each number represented a particular implant model and size, Customers (doctors' offices, clinics, and hospitals) used these numbers when ordering implants, Lot numbers traceability to original production records. Essentially every medical device sold by Dow Corning had a lot number and a catalog number. These numbers were frequently recorded in patients' medical records for the implant surgery. The combination of the lot number and the catalog number represents a unique batch of a particular product size and configuration. To determine if the numbers in your medical records match those for Dow Corning or another manufacturer, call the Claims Assistance Program Toll Free at 1-866-874-6099.

Q5-10. "What are "control" numbers?"

The implants Dow Corning sold were labeled with catalog numbers and lot numbers. Dow Corning did not assign "control" numbers to implants, However, as part of their own inventory management system, some hospitals, clinics, and doctors' offices may have assigned unique control numbers to each implant as it was received, These control numbers might have been recorded on contemporaneous inventory control sheets with specifics about the implant (such as manufacturer, brand, catalog, and lot numbers) and the name of the patient receiving it.

Q5-11. "What medical records and documents are unacceptable as proof of manufacturer?"

Examples of unacceptable proof of a Dow Corning breast implant 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. (For example, a statement from the doctor's
    nurse that "we usually used Dow Corning implants" is unacceptable proof.)

5. A non-contemporaneous statement by your implanting physician, attempting to provide the
    acceptable proof listed in the Proof of Manufacturer Form Instructions 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.

DEFICIENCIES IN PROOF

Q5-12. "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 of a Dow Corning breast implant but do not - submit a Proof
of Manufacturer Form. It is necessary to submit the completed and signed Proof of
Manufacturer Form.

2. You fail to provide a certified copy of medical records for acceptable proof outlined in the
Proof of Manufacturer Form Instructions.

3. An affirmative statement from the implanting physician has been submitted, 0but 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 (s)he removed from you. You need to obtain this statement from the
    physician.

Q5-13. "What is a "certified copy" of my medical records?"

A certified copy is a copy of records with a certificate attached, usually signed by the custodian of records for that office or facility, affirming that the attached pages are true and accurate copies of records in a particular patient's file.

Q5-14. "What is an implant package label? How can I recognize it?"

An implant package label is a label made by the manufacturer with pre-printed information about the breast implant. The label will almost always have the name of the manufacturer, the type of breast implant (saline, for example), the catalog number, and the lot number. Doctors frequently placed these implant labels in a patient's medical files following the implant surgery.

Q5-15. "What does "Cronin" refer to? Is that the name of a breast implant?"

"Cronin" is not the name of a breast implant, but of a plastic surgeon -Dr. Thomas Cronin -from Houston, Texas who developed silicone gel breast implants in conjunction with Dow Corning. As a result, breast implants were frequently referred to as "Cronin implants" in medical records prior to 1972. Dow Corning has agreed only for purposes of the Settlement Option to accept the name "Cronin" as acceptable proof of a Dow Corning breast implant if it was used during or between 1963 and 1971.

Q5-16. "I remember my doctor telling me (or my relative or a friend) that I had Dow Corning
breast implants. Can I rely on that as acceptable proof?"

No.

Q5-17. "What if I can't get my medical records (for example, the doctor has since died, the
records were destroyed or lost, or the doctor won't give them to me)? What can
I do?"

If you cannot find your implanting physician or his/her office no longer has a copy of your records, you can ask for the name of an appropriate responsible person at that office (such as a nurse, a person in charge of the files or records, or another doctor) who can write a letter stating under oath that you were implanted with a Dow Corning breast implant and stating the basis for this conclusion. If you cannot locate anyone qualified to write this letter, there may be other ways to show who made your breast implants.

Q5-18. "My proof of manufacturer documents are not covered by the rules above. Can I still
submit them?

You may send in proof even though it is of a type that is not addressed by the existing rules
-if it reliably establishes what kind of implant you received. The Settlement Facility will then advise you if new rules have been adopted to cover your situation or if Dow Corning has decided to accept your type of proof through the confidential measures established by the Claims Assistance Program.

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