Proof of Manufacturer Frequently Asked Questions

Q17-1:  How do I find out if the doctor who implanted my silicone gel implants used Dow Corning implants?

First, speak with your implanting doctor or other responsible person at that office to determine if they can provide you with information about whether the doctor used Dow Corning breast implants. If you are not able to obtain this information, you may contact Claims Assistance at 1-866-874-6099 and request them to search the list of sales records provided to Claims Assistance by Dow Corning. Confirmation that Dow Corning sold breast implants to your implanting doctor does not in itself constitute acceptable proof under the Plan. You must still meet the POM requirements listed in Question 3 of the POM claim form.

Q17-2:  I received a set of implants in one implantation. Since they were done at the same time, why do I have two different proof evaluations?

For the purposes of the Proof of Manufacturer review, each implant is evaluated on the basis of its own proof. Therefore, each implant must be identified as a Dow Corning implant in a manner outlined in the guidelines for acceptable proof found in Schedule I, Part I of Annex A. 

Q17-3  I submitted documents showing that I was implanted with sheeting (and/or a nipple implant, sponge implant, etc.). I received a letter stating that this was not an eligible implant. Why isn’t this considered a breast implant since it was placed in my breast?

The Settlement Facility is required to comply with the terms of the Plan Documents. Under those documents, eligible breast implants are defined as "all silicone gel and saline-filled implants with silicone elastomer envelopes.…" Implants with sheeting (or nipple implants, sponge implants, etc.) do not meet this definition; therefore, the Settlement Facility is not able to accept your product as eligible for compensation from the Settlement Option. You may, however, pursue a claim against the Litigation Facility if you choose the Litigation Option. You will be provided more information on how to pursue litigation when you receive the Participation Form package.

Q17-4:  I received a Notification of Status letter from the Settlement Facility that stated that I had “No Proof Submitted.” Why did I receive this evaluation when I completed information about my implants on the claim form?

The category of “No Proof Submitted” means that we are unable to confirm the manufacturer of your implant(s) because you did not submit any documents, such as medical records of the implantation surgery, with your Proof of Manufacturer Form. The Settlement Facility is unable to do anything more on your claim for this implant without further documentation from you. Read the Proof of Manufacturer Form Question 3 and Schedule I of Annex A to the Settlement Facility and Fund Distribution Agreement carefully for more information about the types of documents you can submit to confirm your implant manufacturer.

Q17-5:  I received a letter from the Settlement Facility stating that I have an ineligible implant. What does this mean?

The Settlement Facility is required to comply with the terms of the Plan Documents. Eligible implants are defined under those documents. If you do not have an implant that is on the list of eligible implants, then you cannot recover any compensation from the Settlement Option. 

Q17-6:  My doctor sent my implant(s) to Dow Corning for review in 1993. How can I find out if Dow Corning still has my implant(s)?

Dow Corning provided the Settlement Facility with a list of implants that are still in the custody of Dow Corning. To determine if your implants are on this list, call the Claims Assistance Program toll-free at 1-866-874-6099 (within the U.S. and Canada). If your name is on this list, you may request that Dow Corning conduct a review to determine if the implants in their possession were made by Dow Corning. The Claims Assistance Program can provide more information about this process.

Q17-7:  I participated in the Dow Corning PREP (or RAP) program. Who do I call to confirm that the Settlement Facility has a record of that?

Call the Claims Assistance Program toll-free at 1-866-874-6099 (in the U.S. and Canada) and they can assist you. 

Q17-8:  My medical records do not list a brand name of an implant manufacturer; however, they contain numbers that describe the implant(s) that I have. Can these numbers identify who made my implant(s)?

Maybe. Call the Claims Assistance Program toll free at 1-866-874-6099 and they can check the list of catalog, serial, and lot numbers to determine if the numbers in your medical records match an eligible implant.

Q17-9:  If the numbers do match an eligible implant, is this acceptable proof to participate in the settlement?

Depending on who made your implant, you may be eligible for either Class 5, 7 or 9 (see CIG Q1-5 for more information on these class definitions).

Q17-10:  I filed a claim in the original global settlement or RSP and listed breast implants from both Dow Corning and Bristol. As a result, my payment in the RSP was reduced by 50%, and I was told to apply for the remaining 50% in the Dow Corning bankruptcy case. I recently learned that the implant I thought was made by Dow Corning actually wasn’t. What can I do?

The District Court in the Dow Corning bankruptcy issued an Order dated April 23, 2003 that describes a process to allow you to request the remaining 50% of your payment from the RSP Claims Office (not the Dow Corning Settlement Facility). You may contact the MDL-926 office at 1-800-600-0311 to request a copy of the form to complete. The completed form should be returned to the Settlement Facility for processing. Please note that completing the form will permanently withdraw your claim in the Dow Corning bankruptcy case. Any follow-up regarding additional payment will be handled by the MDL 926 Claims Office.

Q17-11:  Several years ago, Dow Corning sent me a letter and attached to it were internal Dow Corning documents in which they reviewed my implants and concluded that they were made by Dow Corning. Is this acceptable proof?

Dow Corning has agreed that admissions made by Dow Corning in internal memoranda stating that implants submitted by or on behalf of a particular claimant were in fact made by Dow Corning constitutes acceptable proof. To be acceptable it must be clear that Dow Corning made an independent determination and was not simply reporting on statements made by others.

Q17-12:  I was a participant in a clinical study of Dow Corning breast implants implanted by Dr. Ben Gregory. Can I rely on my participation in this study as acceptable proof that I have/had Dow Corning implants?

Approximately 50 women were implanted with silicone gel breast implants by Dr. Ben Gregory of Florida as part of a Dow Corning-sponsored clinical study. Dow Corning supplied the names of the study participants to the Settlement Facility and advised that these 50 persons will have acceptable proof of manufacturer of a Dow Corning breast implant. If you were implanted by Dr. Ben Gregory or believe that you were a participant in the Ben Gregory clinical study, call the Claims Assistance Program toll free within the U.S. and Canada at 1-866- 874-6099 for more information.

Q17-13:  My 1985 operative report identifies my breast implants as “Rubin” implants. Is this acceptable proof of a Dow Corning implant?

Credible, contemporaneous documents identifying a claimant’s breast implants as “Rubin” implants, “Rubin Design” implants, or “Q7-2573” implants would be deemed “acceptable” proof of manufacturer for implants implanted between 1984 and 1986.

Q17-14:  I (or my doctor) sent my explanted breast implants to Dow Corning years ago. Does Dow Corning have any information that I can obtain about these implants?

Dow Corning has a number of implants in its possession that were sent to it by physicians and claimants over the last 20 years. Dow Corning has reviewed some – but not all – of these implants and has sent a letter to the Settlement Facility identifying claimants whose implants were determined to be made by Dow Corning. If your name is on the list of claimants whose implants are determined to be made by Dow Corning, then this is acceptable proof. Call the Claims Assistance to determine if your name is on the list or if your implants are in the possession of Dow Corning.

Q17-15:  My sister and I were implanted with breast implants by the same plastic surgeon. His medical records do not list the manufacturer of the implants he used. However, my sister was able to obtain a letter from the plastic surgeon before his death stating that he used only Dow Corning breast implants, and her proof of manufacturer was approved. Can I use her doctor’s statement to establish that I also have Dow Corning breast implants?

Yes, as long as you can establish that you were implanted with breast implants by the same plastic surgeon during the time frame that he stated he used Dow Corning breast implants. Generally, you can do this by submitting a copy of your implant medical records.

Q17-16:  I cannot obtain my original implantation records. I hired a professional expert to review and identify them. His report states that the implants were made by Dow Corning but it does not list a Unique Identifier. Is this acceptable proof?

No. If the report does not list a Unique Identifier, the proof is unacceptable. We will submit the report and other documentation (without your identifying information) to Dow Corning to determine if they will accept the proof. 

Q17-17:  I was implanted in 1975. My implanting surgeon no longer has any medical records, but his office wrote a letter stating that my implants were manufactured by Dow Corning.  Is this acceptable?

This letter is acceptable to show you were implanted by Dr.Smith; however, the affirmative statement from Dr. Smith is deficient because it does not state he “only” or exclusively used Dow Corning implants at this time. It also does not establish the basis for his conclusion.

Q17-18:  On my implant history, I listed that I had a Dow Corning implant and another implant from Bristol. I provided proof that I had a Dow Corning implant, but now I received a letter from the Settlement Facility asking me to send more information about my Bristol implant. What should I do?

You must make a "good faith" effort to provide available documents identifying the other implant as made by Bristol. If you are not able to obtain any other documents, please write to the Settlement Facility and state this or describe the steps you took to obtain the requested information. Until we hear from you, your claim review cannot be finalized.

Q17-19:  I submitted additional information about my Baxter implant to the Settlement Facility. Will the Settlement Facility send or share that information with the MDL 926 Claims Office?

Yes, you do not have to resubmit your documents to the MDL 926 Claims Office because we have a document sharing arrangement. However, you will need to contact the MDL-926 Claims Office directly (1-800-600-0311) to determine the status of your claim and any actions that might be necessary on your part.

Q17-20:  I submitted my Proof of Manufacturer documents that included an affirmative statement from my implanting doctor and a copy of the Removal Assistance Program letter from Dow Corning in which Dow Corning paid my surgeon $1,200 when my implants were removed in 1993. I received a Notification of Status letter stating that my affirmative statement had a minor deficiency. The Notification of Status letter did not refer to my participation in the Removal Assistance Program. What should I do?

If you believe that the Settlement Facility made an error in reviewing your claim, write a letter to the Settlement Facility and ask for an error correction review. Point out the specific error that you believe was made. The Settlement Facility will re-review the claim and, if an error is found, a corrective letter will be issued.