Hummer Law Offices    10333 Seminole Blvd.   Suite 14    Largo,  Florida  33778     1-800-433-8420

Information about "Proof of Manufacturer"
Updated Rules for Proof of Manufacturer
(Last update: April 3, 1996)
 

Note: Those marked with an asterisk (*) added since the printing of the blue Proof of Manufacturer forms.

Acceptable Proof

    1. Hospital records of the surgeon's report of the surgery-written at the time of the implantation surgery-that
         specify the brand name or manufacturer of the breast implants that were implanted.

  *2. A certified copy of medical records that contain the implant package label. 
        Note: A certified copy is only required if the label-
       
        (a).  is on a page that does not affirmatively reveal it to be part of your hospital or medical records and
        (b).  does not have a lot number or serial number on it. 

  *3. Implant labels clearly marked with lot and serial number.  The Claims Office will maintain 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 the implantation surgery-that specify the brand
        name or manufacturer of the implants.

   5. An affirmative statement from the implanting physician (or responsible person at the treating facility where
        the implantation took place) attesting that you were implanted with a particular manufacturers implants. 
        The person making this affirmative statement must also prove the basis for this conclusion.  This type
        of proof is acceptable only if the records outlined in #1 and #2 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.

 *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. Medical records of the explanting physician (or other physician who examined the implant before or after
         removal surgery) -written at the time of the examination of the implant-if that physician points out a specific
         characteristic of the implant that is on the Claims Office's list of characteristics unique to specific
         manufacturers or brand of implants.  To date, two unique characteristics are on that list.

        (1). Polyurethane
        (2). "3M" or "McGhan" stamped on the outside of the envelope.

  *8. McGhan's form Biocell "Patient Acknowledgement" signed by the implant recipient.

   *9. Manufacturer or brand-specific implant control sheets, with cross-references to a specific patient, that
         reasonably appear to be contemporaneously kept records in the hospital or implanting physician's office.

 *10. Manufacturer's invoice or packing list contained in claimants 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, we may require a certified copy of the records or a supplemental statement
         from the records custodian.

 *11. Manufacturer's catalog with a particular type of implant circled or otherwise marked.  If contained in a
         certified copy of claimant's medical or hospital records relating to the implant surgery.

 *12. Warranties mentioning a breast implant noted on Exhibit G as being a covered implant, if the Warranty is
         contained in a certified copy of the claimant's medical or hospital records.

 *13. Surgitek's from "Patient Conformed Consent" -Gel filled Mammary Implants" signed by the implant
         recipient and dated close to the date of the implantation surgery; accompanies by other contemporaneous
         medical or hospital records verifying that the implantation surgery actually occurred.

 *14. For explantations before January 1, 1996, contemporaneous medical records of the explanting physician
         specifically stating that an explanted breast implant is a "McGhan" or a "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.

 Unacceptable Proof

  15. Your own recollection (or that of a friend or relative) regarding the brand name or manufacturer of your
         implants.

*16. Records from the international implant registry.

*17. Identifying reports from a physician who examined the implants during or after removal surgery, if identifiers
        are not on the Claims Office's list of unique characteristics are the basis of the identification , or the
        physician merely opinions based on his or her experience, that the prosthesis was made by a certain
        manufacturer.

*18. A non-contemporaneous statement by the implanting physician, attempting to supply the acceptable proof   
        found in # 5 above , but qualifying the affirmative statement concerning type of implant used by phrases like
        "if I remember correctly", or "to the best of my memory".

*19.  A non-contemporaneous statement by the implanting physician, attempting to provide the acceptable proof
         found in # 5 above, that does not name the participant as the person receiving a particular type or brand of
         implant.
 

How to determine if a McGhan implant, implanted after 3/30/84, will be considered a 3M implant for purposes of the Revised Settlement Program:
 

You must provide proof that the implant had the name "3M" on it, or that it has a 3M serial number.  The list of McGhan serial numbers qualifying as 3M implants is available upon request from the Claims Office.  McGhan/3M lot, catalog, and style numbers are not the same as serial numbers.  Lot, catalog, or style numbers cannot provide information that will allow us to classify one of these implants as covered by 3M

How to determine if a Heyer-Schulte implant, implanted after 3/30/84, will be considered a Baxter implant for the purposes of the Revised Settlement program.
 

You must provide proof that your implants have a Baxter lot number.  The 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 cannot provide information that will allow us to classify one of these implants as covered by Baxter.   

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