Proof of manufacturer article

1. The first method to try is to write the Plastic Surgeon or the physician who implanted you. Please use something similar to the sample letter provided at the end of this write-up! You are primarily interested in Proof of Manufacturer and secondarily, your medical records, if those are also available. Your original operative report might be valuable at a later date to the physician explanting you. The letter must mention your primary reason for writing is to obtain Proof of Manufacturer for legal reasons. Even in those states where you can be denied access to your own medical records, you usually can obtain them if you need them for legal purposes.

Many physicians, even though they have discarded your records because they are no longer required to keep them under your state's laws, might have the information in their surgical log, if you were implanted at an operating suite at their office. Many keep them well beyond what is required by law knowing most of us are "repeat customers" as they rupture, harden and look deformed, etc.

2. If you do not know where your Plastic Surgeon (abbreviated from now on as P/S) or implanting physician is, try SWTICHBOARD to locate him. If this does not yield his current address, contact the American Society of Plastic & Reconstructive Surgeons at 1-800-635-0635. Even if the P/S has retired or died, they will be able to tell you that and perhaps who now his records. Some states also have Medical Societies they can also be helpful in locating Doctors.

 

If your implanting physician was not a Board Certified Plastic Surgeon but was a general surgeon, dermatologist, etc., first try Switchboard or a similar search engine to locate him. If you have no luck, contact the Board of Medical Specialists, 1-800-776-2378. If he is still Board Certified, you can probably locate him through his certifying Board which they can give you. To locate that body, try Switchboard again, MEDICAL BOARDS & AMA which provides a link to the American Medical Association's Web Site and the certifying bodies of many medical specialties.

Or, contact your library or doctor for help in locating the address and

phone number of your implanting physician's certifying organization. Some specialties have more than one. Persistence will pay off! Only about 60% of the physicians belong to the American Medical Association. Membership is expensive and it is not required for licensing to practice. They have a physician locator at their Home Page.

3. If your implanting physician cannot be located or his records did not include who made your implants in the operative report, Office Notes or Medical Records or the Product I. D. Tag and you were implanted in a hospital, you need to write the hospital something similar to the sample letter at the end of this write-up (one for writing the doctor and another if writing the hospital). Hospitals frequently have a charge, typically $35, so it might be wise to call and ask for the Medical Records Department to find out what that charge

will be so you can include a check. If you cannot afford the fee charged, explain this to them and see if your doctor can request the necessary records. They will normally send them to your physician at no charge. To find out the phone number of the hospital if out-of-town, again try Switchboard.

 

Many hospitals like the banks have changed their names over the years. If you cannot find the address and phone number on Switchboard or one of the other similar search engines, you might visit the library to look at the Yellow Page listings for hospitals for that city if you no longer live there to see if you recognize it from the address or because they often keep the old name as part of the new one. You might also try U. S. SUPPORT GROUPS to see if you can find one in that area you can contact who might know what the present name is and can give you the address and phone number.

Even if the Medical Records Department of the hospital or same day surgical center where you were implanted say they no longer have your records, write something similar to the sample letter asking for them to reply in writing. Often, the records will arrive in the mail even though you were told on the phone they were no longer available!

4. If your implanting physician has retired, try Switchboard to see if his home phone number is listed. If so, call him to ask where your records are if they still exist. Often, another Plastic Surgeon will retain his records long after required by law knowing this is a "repeat business" and you might come back to who has been "entrusted" with them. If you physician has died or retired and you cannot locate him, call the local "union" office you might say where he practiced when he retired, such as "Orange County Medical Association" or the Medical Association located in the state capital where he was practicing as to where his records are.

In some areas, I have found firms listed under the Yellow Page heading, "Office Records-Storage" and "Storage-Household & Commercial" will at times have old records for which they charge a nominal fee for a copy. You can find phone directories for major cities at your local library and the same CD Roms I have. A search under "BUSINESS ARCHIVES" of my CD ROM of the Yellow Pages throughout the United States came up with 27 alone with this as part of their name.

If the physician has died and the Medical Association does not know where his records are, ask if they can tell you the county of legal residency at his death (might be different than where his office was located). This is where his Will would be filed with the Probate Court. Ask long-distance information for the phone number of the Probate Court. It will be located in the county seat. If you do not know the county in which the doctor was a legal resident at his death, you might be out of luck. If he died while still in practice, it is probably safe that he lived in a county near his office. Go by the library to check a good atlas for the names of those counties and the county seat.

The Probate Court can often tell you the name and address of the Executor for the Estate over the phone. They might require a written request and a nominal sum such as $1 for a photostat from the Probate Court Record on him giving the name and address of the Executor (also called Personal Representative). Write the Executor essentially the same letter you would have written to the physician included here if he were still living.

In unusual cases, your implanting Plastic Surgeon or physician might have gone to jail and/or had his license revoked or suspended. This happened with Dr.Dale B. Dubin in Tampa, FL. His records I now understand are no longer available after lengthy discussion with the support group leaders in that area. However, many did obtain their implantation records long after he went to jail from a business who stored them in Tampa for a nominal fee. Dr. Dupin also warned women in a newspaper article in 1988 on the high rate of ruptures that were taking place among his patients before going to jail.

If the medical association does not know where the records are of a physician who has gone to jail and/or lost his license to practice, contact the support group leaders in that area and also, try the Yellow Page headings already mentioned for businesses who store records.

5. Some hospitals have the information on microfiche from many years ago, long after required by law, but will only supply it if they are subpoenaed or your doctor writes a Letter of Medical Necessity. I feel it is a necessity that you know who the manufacturer of your implants was and have the Lot and Catalog numbers so you can find out the chemicals in that batch of implants if your health problems do not improve, worsen or if you feel fine now, you develop them in the future.

If you have a treating physician, particularly one who under stands silicone disease, talk with him about writing a letter to the hospital for you saying that he feels it is necessary to have the Product I. D. Tag from your records, if it is available or the manufacturer, Lot and Catalog Numbers from the surgical log and your operative and Progress Notes because you are continuing to suffer adverse effects probably attributable to your implants or could in the future.

6. The implantation records might be available in another physician's records who treated you. It might be worth a try for example, to write asking your Gynecologist if he or she has a copy of your implantation records or a General Surgeon who might have done a breast biopsy over the years, for example.

7. If you were implanted while you or your spouse was in the military and it was at one of their or a VA facility, call the medical records department to find out what the procedure is for obtaining your records. In some cases, they might only release the records to your physician who would have to request them. Find out and do whatever is necessary. To find the telephone number of the facility, try Switchboard, telephone information where it is located, etc.

8. If you have trouble locating Proof of Manufacturer and are a recipient of one of the eligible implants you believe of those covered by the Revised Settlement already mentioned, also call the Legal Assistance Office at 1-513-665-9770 for advice and hints on how to obtain it or if you have an attorney, call him. Unfortunately, if you are a recipient only of Dow Corning implant(s), they have only a recorded message, at present. In that case, consult those for additional guidance who you recognize are knowledgeable on the breast implant issue.

9. If all else fails, you may have your implants identified after explant. In some cases, the shells are totally disintegrated and identification is not possible for this reason. This is why you need to make very effort to obtain Proof of Manufacturer from the sources mentioned. DO IT NOW!

If you have already been explanted and need to have your implants identified, you might contact Dr. Saul Puszkin's office. I spoke to him recently and the charge is $250. I suggest they be sent only by overnight delivery. You should include a letter in with them you wish to have them identified for legal purposes, enclose your check made out in Dr. Puszkin's case, to Health Sciences, instructions on where you wish your implants returned to, etc. Things can change so verify the current charge including to send them back to you via overnight deliver and the address to send them to by calling currently, 1-212-342-7272 and save that air bill carefully until your implants arrive safely back in your possession.

The facility or pathologist who you have chosen to identify your implants will send or fax you shipping protocol and suggestions. If you have not been explanted as yet, I suggest having your implants sent directly by the Pathologist for the facility where you have it done directly to whoever you choose to identify them. They are thoroughly familiar with how to send them. There are several who are capable at identifying implants; consult support group members for who they would suggest also.

If your implants are sent directly from the facility where you are explanted with you never touching them until they have been identified, no one can ever say a friend lent you hers for this purpose or some such. Be safe and have them go direct if explant has not taken place and you have been unable to obtain adequate Proof of Manufacturer.

SAMPLE LETTER TO YOUR IMPLANTING PHYSICIAN

YOUR NAME

ADDRESS, CITY, STATE & ZIP CODE, TELEPHONE#

DATE

CERTIFIED RETURN RECEIPT#_________________________

NAME OF IMPLANTING PHYSICIAN

ADDRESS

City, State & Zip Code

RE.: Your Name at Time Implantation

Your Present Name

Date of Birth, Social Security Number

Date of Surgery(ies):

Dear Dr. :

Please send me a complete copy of my medical records from my breast implant surgery, to include the operation, radiology and pathology reports and lab tests for my personal use. I need Proof of Manufacturer for the Breast Implant Litigation. I need to have, if at all possible, the Product I. D. Tag showing who manufactured my breast implants, how many cc's they weighed or size on implantation and the Lot and Catalog numbers. If the Product I.

D. Tag is for any reason on a separate sheet and not an integral part of my medical records, please attach a certification that is custodian of my records, it was made from the original.

The Paragraph below only if you were operated on at the P/S' office: If you no longer have my records or have trouble locating them, please send me on your letterhead under your signature who your Surgical Log shows manufactured them, how many cc's they weighed or size and the Lot and Catalog numbers. Or, attach a copy of the log and certify in the letter as custodian of the records, this was made from the original Surgical Log. Please be sure that is any photostat of the Log can be read and if not, please type the information on your letterhead and sign it. Thank you.

Sincerely,

X______________________________

Mary Smith Doe**

------------------------------------------------------------

SAMPLE LETTER TO THE HOSPITAL WHERE YOU WERE IMPLANTED

YOUR NAME

ADDRESS, CITY, STATE & ZIP CODE, TELEPHONE#

DATE

CERTIFIED RETURN RECEIPT#_________________________

 

 

MEDICAL RECORDS DEPARTMENT

NAME OF HOSPITAL

ADDRESS, CITY, STATE & ZIP CODE

RE.: Your Name at Time Implantation

Your Present Name

Date of Birth, Social Security Number

Date of Surgery(ies): Gentlemen:

 

I need to obtain Proof of Manufacturer for the breast implants put in per above for the Breast Implant Litigation. Ideally, this should be the Product I. D. Tag showing the manufacturer, Lot and Catalog Numbers and number of cc's each weighed or size, on implantation. This might have been placed on my operative records or Progress Notes, depending on whatever is customary at your facility.

If you do not have the Product I. D. Tag, then please send me a copy of my operative or Progress Notes if it mentions who the manufacturer or brand was such as Dow Corning, Silastic, Cronin, Hyer-Shulte, Surgitek-Medical Engineering, Cox-Uphoff (CUI), 3M (Minnesota Mining & Manufacturing), McGhan, Mentor, Bioplasty, etc. If you are unable to tell, then send me a copy of the operative report, surgical records and Progress Notes.

If you no longer have my records, then please obtain this information from the Surgical Log. I would appreciate a letter on your stationery stating who the surgical log showed was the manufacturer, the Lot and Catalog or otheridentifying data and number of cc's or size. Or, a copy of the actual Log with certification attached that this was from your original records. If the information cannot be read on the photostat, then please type it on your letterhead and have an appropriate official sign the letter.

If the Surgical Log or my records above are no longer available and this information is available on microfiche under certain circumstances, please advise me in writing under what conditions the information I need can be looked up.

Enclosed is my check for $_______made out to your hospital.*

Thank you.

Sincerely.

X_______________________________

Mary Smith Doe*

 

*If your maiden name is Smith which you went by at the time of your surgery and your married name is now Doe, for example, sign both. If you had another married name at the time and a different one now, again, sign both. If you do not have access to post office certified materials; fill out the receipt number above at the Post Office. AT THIS LATE DATE; TAKE NO CHANCES.. SEND THE INQUIRIES ONLY BY CERTIFIED MAIL WITH A RETURN RECEIPT REQUESTED.

If you do not receive a reply within 30 days of the date the receipt shows the doctor or hospital received your letter, send a second one giving them a 3 week deadline from the receipt of your letter to provide the information or you will complain to the Board of Medicine of the state the doctor practices in or the hospital's licensing authority.

 

  


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