Breast Implant Line of Canada

Answers to Questions About Silicone Gel Breast Implants

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QUESTION:
Dear Ms. Zuckerman, I have been recently diagnosed with breast cancer and it seems that a mastectomy may be a solution. I am worried about losing my femininity and wonder if you can give me some advice on what you think of breast implants post-mastectomy.

ANSWER:
The following letter was written to and answered by:
Diana Zuckerman, Ph.D. President National Research Center for Women & Families
PDF | Center4Research

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

QUESTION:
What other medical studies are needed?

ANSWER:
The following document is credited to Frank Vasey, MD, and Josh Feldstein, from "The Silicone Breast Implant Controversy". The document excerpt examines key topics regarding silicone disease, particularly those which require more investigation - including, but not limited to: Patient Pre-disposition, rate of shell breakdown, emotional disorders and silicone disease, silicone and sexuality, and treat...ment.
Read More (DOC)

1. I have implants and have had no problems. Should I have them removed?: We do not recommend removal of non-problematic implants. Read all the information available, so that you are knowledgeable about possible complications, side effects, etc. Have regular exams and mammography (performed at a facility where technicians have experience with "displacement" mammograms), as recommended by your physician. It is important that you tell the technician that you have implants. This will help insure that the mammogram is done correctly and safely.

The following physical symptoms may indicate a problem with your implants:
pain or hardening of your breasts, rashes, extreme fatigue, fevers, joint and/or muscle pain, burning or "electric" sensation, skin "thickening" or skin hardening. If you experience these or other prolonged, unexplained or un-diagnosed physical symptoms, consult your surgeon; there may be a problem with your implants. You may also wish to consult a rheumatologist or internist.

(Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46)
2. How can I tell if my implant has ruptured? If it has ruptured, should it be removed?: In addition to manual examination and mammography, the physical symptoms that are described in question 1 can also apply to implant rupture. If you have experienced any trauma to the chest, this too can cause implant rupture. You may also notice a difference in size or feel to a breast with a ruptured implant.

It may be easier to determine implant rupture by having a mammogram. This procedure can detect most ruptures and residual silicone. Ruptured implants should be removed.

(Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46)
3. If an implant is removed, should the scar tissue "capsule" also be removed?: Yes. If an implant has ruptured, most of the silicone will migrate to the surrounding tissues and lymph nodes. It is best to remove as much of the silicone gel as possible, thus lessening the likelihood of complications.

(Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46)
4. I went to my doctor, and he/she assured me that my implants are intact, not ruptured. I am still having some physical problems. How can this be explained?: Even an intact implant has a normal amount of "gel bleed". This microscopic amount of silicone gel that bleeds through the outer envelope of the implant can be enough to cause the symptoms discussed above. Also note that ruptures can be missed by even the best mammograms.

(Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46)
5. My implants have hardened, and my surgeon has told me it is a "simple office procedure" to break the scar tissue. What is this procedure and should I agree to it?: Your surgeon is referring to a "closed capsulotomy." When breasts become hard, this is because scar tissue has formed around the implant. Breaking up the scar tissue will make the breast soft again; however, accomplishing this by closed capsulotomy (manual pressure on the breast) may cause the implant to tear or rupture. While this procedure may seem simpler than an "open capsulotomy" (a surgical procedure), the risks of implant rupture are great. Although for 20 years, plastic surgeons were advised and taught how to do this procedure, the manufacturers' most recent package inserts caution
surgeons not to perform closed capsulotomies because of the high risk of rupture.

If your surgeon performs an open capsulotomy, it is recommended that old implants not be re-inserted, as there is a risk that the old implant could be damaged. Also be aware that your old implants are YOUR property and you should keep them for examination by an independent lab for analysis. Your request to save your implants should be made, in writing, to your surgeon and hospital before your surgery.

(Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46)
6. How long do silicone gel implants last?: Although inserting implants was originally promoted as a "once in a lifetime procedure", manufacturers are now acknowledging that this is not true. Actual "body life" of an implant is probably closer to 10 years. You should be aware that if you are considering this procedure, depending upon your age at time of implantation, you will probably need to undergo replacement surgery at some point in the future. You should also be aware that in the current package inserts for Dow implants, there is no mention of a time warranty.

(Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46)
7. Are saline filled implants safer than silicone gel?]: While no breast implant has been "proven safe by FDA standards, saline filled implants are probably safer than silicone gel implants, because saline (salt water) is harmless and there is no silicone gel bleed; however, the shell of the saline implant is made of silastic rubber (a silicone product). Some women with saline implants have reported medical problems similar to those of women with silicone gel implants, possibly indicating that the shell can stimulate reactions in some women, but a major concern of the gel-filled implant--leaking silicone - is not relevant.

(Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46)
8. What are "combination" Implants and are they safer?: "Double and triple lumen" implants have a silicone gel-filled "sack" floating within 1 or 2 larger silicone envelopes that are then filled with saline (salt water). Depending on the size of the implant, these combination" styles may have less silicone gel than an implant which is completely filled with silicone gel, but any gel in the product may cause problems, as it can bleed through the saline.

(Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46)
9. Why are polyurethane-coated Implants (Meme, Natural Y and Replicon) no longer available? Are there specific problems with these implants?: Polyurethane-coated implants are no longer available because the manufacturer voluntarily withdrew them from the market in April 1991. This was based on concerns about fragmentation of the polyurethane and the fact that toluene-diamine (TDA-a chemical breakdown that occurs when polyurethane is in the body) is a carcinogen.

(Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46)
10. Is TDA transmitted through breast milk?: Aegis Analytical Laboratories provides a diagnostic test designed to measure the elimination of TDA in urine and breast milk. Have your physician contact : Aegis Laboratories at (615) 331-5300 to request an appropriate sample collection kit. National Medical Service also offers testing. They can be reached at (215) 657-4900.

(Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46)
11. I am having (or have had) my implants removed. Where can I send them for analysis?: Dr. Pierre Blais is collecting and analyzing explants. Patients who wish to know how and why their implants failed can contact Dr. Blais about his research program: 496 Westminster Avenue Ottawa, Ontario K2A 2V1 Canada phone: (613) 728-8688 fax: (613) 728-0687

(Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46)
12. Why have the implants been on the market IF they were not approved by the FDA?: Silicone gel-filled breast implants were on the U.S. market before the FDA received regulatory authority over medical devices in 1976. They were therefore "grandfathered" onto the market. The FDA, in 1991, required manufacturers who wished to continue marketing their implants to submit Pre-Market Approval (PMA) applications, thus initiating FDA review of safety and effectiveness data. As part of this process, advisory panel meetings were held and recommendations offered in November 1991. On January 6, 1992, the FDA called for a moratorium on the use of silicone gel implants. This was a voluntary measure - at their discretion, surgeons can still implant silicone gel breast implants. During this moratorium, the FDA reconvened the advisory panel to consider new information and offer new recommendations.

[As of October 2006, silicone gel breast implants were allowed back onto the Canadian market and by November 2006, they were back on the USA market.]

(Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46)
13. Are there other women with problems similar to mine?: Public Citizen has received inquiries from over 2000 consumers concerning this issue. Command Trust Network (a U.S. national support group) has received over 8000 requests for information. These numbers are increasing daily as public awareness of this issue increases.

[We, at Breast Implant Line of Canada have received thousands of inquiries.]

(Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46)
14. I want to report my Implant problems to the FDA. How can I do that?: Call toll-free 1-800-638-6725. In Maryland, call collect 1-301-881-0256. The U.S. Pharmacopeia, which operates this program for the FDA, will guide you through the reporting process.

[In Canada, there is no official place to register a problem other than with your plastic surgeon, who hopefully will keep accurate accountings of all reports and send them to Health Canada and the manufacturers]

(Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46)
15. Is anyone keeping records or a registry of women with Implants - those with problems and those who are problem-free? Who will keep us updated on new Information? (Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46): At this time, there is no U.S. national registry specifically for breast implants, although it is an option that the FDA is considering. Medic Alert operates a registry for all individuals with medical device implants (including breast implants). We suggest you call them toll free 1-800 344-3226 and enroll. The cost is $25 for the first year, then $15 for each following year. You will be sent update forms every six months. Your information will remain confidential, and you will be notified of recalls, problems, etc.

[For years, we in Canada have been trying to get a Canadian National Breast Implant Registry established…so far to no avail!]
16. I am considering implant surgery. What information should I ask for before I make my decision?: Ask to see the package inserts that your surgeon has. These are packaged with the product, and he/she should be willing to share them with you.

The FDA also has patient information, as do Public Citizen and Command Trust Network. Read everything available, so that your decision is an informed.
17. After having silicone gel breast implants, can lumps of silicone appear in various parts of our bodies, such as in arms, legs, feet, etc.? (Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46): Yes, usually a lump (or nodule) appears and a biopsy shows that there is silicone inside. … I’ve heard of them in many other parts of the body. They can be granulomas that look like a nodule. Click here for an example in the chest and arm

(provided by Dr. Diana Zuckerman, Ph.D. President National Research Center for Women & Families)
18. How can breast implants cause heart disease?: Excerpt from Vitalchi.com:
The rupture of a silicone or saline transplant and scar tissues can block the energetic and blood supply to the heart, the lungs, and lymphatic nodes in the carotid artery and axillary region causing the chest pain, neck pain, shoulder pain, and scapular pain.
19. Can Implants Impede Breast Cancer Detection?: Breast implants may make it harder for a mammogram to find breast cancer because it's difficult for the breast tissue behind the implant to be seen clearly enough. This might be a particular concern for women at high risk for developing breast cancer, such as women with a strong family history of breast and/or ovarian cancer.

That said, the current data suggest that neither silicone nor saline implants are associated with an increased risk of breast cancer. Either type of implant can have complications, however, such as decreased nipple sensation, pain, unattractive appearance, scarring, infection, or rupture of the implant.
(Dr. Martee L. Hensley)



	Answers to Questions About Silicone Gel Breast Implants Please click on the question to see the answer. FAQ Downloads and Links QUESTION: Dear Ms. Zuckerman, I have been recently diagnosed with breast cancer and it seems that a mastectomy may be a solution. I am worried about losing my femininity and wonder if you can give me some advice on what you think of breast implants post-mastectomy. ANSWER: The following letter was written to and answered by: Diana Zuckerman, Ph.D. President National Research Center for Women & Families PDF \| Center4Research -------------------------------------------------- QUESTION: What other medical studies are needed? ANSWER: The following document is credited to Frank Vasey, MD, and Josh Feldstein, from "The Silicone Breast Implant Controversy". The document excerpt examines key topics regarding silicone disease, particularly those which require more investigation - including, but not limited to: Patient Pre-disposition, rate of shell breakdown, emotional disorders and silicone disease, silicone and sexuality, and treat...ment. Read More (DOC) 1. I have implants and have had no problems. Should I have them removed? We do not recommend removal of non-problematic implants. Read all the information available, so that you are knowledgeable about possible complications, side effects, etc. Have regular exams and mammography (performed at a facility where technicians have experience with "displacement" mammograms), as recommended by your physician. It is important that you tell the technician that you have implants. This will help insure that the mammogram is done correctly and safely. The following physical symptoms may indicate a problem with your implants: pain or hardening of your breasts, rashes, extreme fatigue, fevers, joint and/or muscle pain, burning or "electric" sensation, skin "thickening" or skin hardening. If you experience these or other prolonged, unexplained or un-diagnosed physical symptoms, consult your surgeon; there may be a problem with your implants. You may also wish to consult a rheumatologist or internist. (Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46) 2. How can I tell if my implant has ruptured? If it has ruptured, should it be removed? In addition to manual examination and mammography, the physical symptoms that are described in question 1 can also apply to implant rupture. If you have experienced any trauma to the chest, this too can cause implant rupture. You may also notice a difference in size or feel to a breast with a ruptured implant. It may be easier to determine implant rupture by having a mammogram. This procedure can detect most ruptures and residual silicone. Ruptured implants should be removed. (Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46) 3. If an implant is removed, should the scar tissue "capsule" also be removed? Yes. If an implant has ruptured, most of the silicone will migrate to the surrounding tissues and lymph nodes. It is best to remove as much of the silicone gel as possible, thus lessening the likelihood of complications. (Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46) 4. I went to my doctor, and he/she assured me that my implants are intact, not ruptured. I am still having some physical problems. How can this be explained? Even an intact implant has a normal amount of "gel bleed". This microscopic amount of silicone gel that bleeds through the outer envelope of the implant can be enough to cause the symptoms discussed above. Also note that ruptures can be missed by even the best mammograms. (Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46) 5. My implants have hardened, and my surgeon has told me it is a "simple office procedure" to break the scar tissue. What is this procedure and should I agree to it? Your surgeon is referring to a "closed capsulotomy." When breasts become hard, this is because scar tissue has formed around the implant. Breaking up the scar tissue will make the breast soft again; however, accomplishing this by closed capsulotomy (manual pressure on the breast) may cause the implant to tear or rupture. While this procedure may seem simpler than an "open capsulotomy" (a surgical procedure), the risks of implant rupture are great. Although for 20 years, plastic surgeons were advised and taught how to do this procedure, the manufacturers' most recent package inserts caution surgeons not to perform closed capsulotomies because of the high risk of rupture. If your surgeon performs an open capsulotomy, it is recommended that old implants not be re-inserted, as there is a risk that the old implant could be damaged. Also be aware that your old implants are YOUR property and you should keep them for examination by an independent lab for analysis. Your request to save your implants should be made, in writing, to your surgeon and hospital before your surgery. (Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46) 6. How long do silicone gel implants last? Although inserting implants was originally promoted as a "once in a lifetime procedure", manufacturers are now acknowledging that this is not true. Actual "body life" of an implant is probably closer to 10 years. You should be aware that if you are considering this procedure, depending upon your age at time of implantation, you will probably need to undergo replacement surgery at some point in the future. You should also be aware that in the current package inserts for Dow implants, there is no mention of a time warranty. (Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46) 7. Are saline filled implants safer than silicone gel?] While no breast implant has been "proven safe by FDA standards, saline filled implants are probably safer than silicone gel implants, because saline (salt water) is harmless and there is no silicone gel bleed; however, the shell of the saline implant is made of silastic rubber (a silicone product). Some women with saline implants have reported medical problems similar to those of women with silicone gel implants, possibly indicating that the shell can stimulate reactions in some women, but a major concern of the gel-filled implant--leaking silicone - is not relevant. (Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46) 8. What are "combination" Implants and are they safer? "Double and triple lumen" implants have a silicone gel-filled "sack" floating within 1 or 2 larger silicone envelopes that are then filled with saline (salt water). Depending on the size of the implant, these combination" styles may have less silicone gel than an implant which is completely filled with silicone gel, but any gel in the product may cause problems, as it can bleed through the saline. (Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46) 9. Why are polyurethane-coated Implants (Meme, Natural Y and Replicon) no longer available? Are there specific problems with these implants? Polyurethane-coated implants are no longer available because the manufacturer voluntarily withdrew them from the market in April 1991. This was based on concerns about fragmentation of the polyurethane and the fact that toluene-diamine (TDA-a chemical breakdown that occurs when polyurethane is in the body) is a carcinogen. (Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46) 10. Is TDA transmitted through breast milk? Aegis Analytical Laboratories provides a diagnostic test designed to measure the elimination of TDA in urine and breast milk. Have your physician contact : Aegis Laboratories at (615) 331-5300 to request an appropriate sample collection kit. National Medical Service also offers testing. They can be reached at (215) 657-4900. (Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46) 11. I am having (or have had) my implants removed. Where can I send them for analysis? Dr. Pierre Blais is collecting and analyzing explants. Patients who wish to know how and why their implants failed can contact Dr. Blais about his research program: 496 Westminster Avenue Ottawa, Ontario K2A 2V1 Canada phone: (613) 728-8688 fax: (613) 728-0687 (Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46) 12. Why have the implants been on the market IF they were not approved by the FDA? Silicone gel-filled breast implants were on the U.S. market before the FDA received regulatory authority over medical devices in 1976. They were therefore "grandfathered" onto the market. The FDA, in 1991, required manufacturers who wished to continue marketing their implants to submit Pre-Market Approval (PMA) applications, thus initiating FDA review of safety and effectiveness data. As part of this process, advisory panel meetings were held and recommendations offered in November 1991. On January 6, 1992, the FDA called for a moratorium on the use of silicone gel implants. This was a voluntary measure - at their discretion, surgeons can still implant silicone gel breast implants. During this moratorium, the FDA reconvened the advisory panel to consider new information and offer new recommendations. [As of October 2006, silicone gel breast implants were allowed back onto the Canadian market and by November 2006, they were back on the USA market.] (Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46) 13. Are there other women with problems similar to mine? Public Citizen has received inquiries from over 2000 consumers concerning this issue. Command Trust Network (a U.S. national support group) has received over 8000 requests for information. These numbers are increasing daily as public awareness of this issue increases. [We, at Breast Implant Line of Canada have received thousands of inquiries.] (Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46) 14. I want to report my Implant problems to the FDA. How can I do that? Call toll-free 1-800-638-6725. In Maryland, call collect 1-301-881-0256. The U.S. Pharmacopeia, which operates this program for the FDA, will guide you through the reporting process. [In Canada, there is no official place to register a problem other than with your plastic surgeon, who hopefully will keep accurate accountings of all reports and send them to Health Canada and the manufacturers] (Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46) 15. Is anyone keeping records or a registry of women with Implants - those with problems and those who are problem-free? Who will keep us updated on new Information? (Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46) At this time, there is no U.S. national registry specifically for breast implants, although it is an option that the FDA is considering. Medic Alert operates a registry for all individuals with medical device implants (including breast implants). We suggest you call them toll free 1-800 344-3226 and enroll. The cost is $25 for the first year, then $15 for each following year. You will be sent update forms every six months. Your information will remain confidential, and you will be notified of recalls, problems, etc. [For years, we in Canada have been trying to get a Canadian National Breast Implant Registry established…so far to no avail!] 16. I am considering implant surgery. What information should I ask for before I make my decision? Ask to see the package inserts that your surgeon has. These are packaged with the product, and he/she should be willing to share them with you. The FDA also has patient information, as do Public Citizen and Command Trust Network. Read everything available, so that your decision is an informed. 17. After having silicone gel breast implants, can lumps of silicone appear in various parts of our bodies, such as in arms, legs, feet, etc.? (Thanks to Pam Dowd for sending the following from the evidentiary files of breast implant litigation. BMS79866/1142/46) Yes, usually a lump (or nodule) appears and a biopsy shows that there is silicone inside. … I’ve heard of them in many other parts of the body. They can be granulomas that look like a nodule. Click here for an example in the chest and arm (provided by Dr. Diana Zuckerman, Ph.D. President National Research Center for Women & Families) 18. How can breast implants cause heart disease? Excerpt from Vitalchi.com: The rupture of a silicone or saline transplant and scar tissues can block the energetic and blood supply to the heart, the lungs, and lymphatic nodes in the carotid artery and axillary region causing the chest pain, neck pain, shoulder pain, and scapular pain. 19. Can Implants Impede Breast Cancer Detection? Breast implants may make it harder for a mammogram to find breast cancer because it's difficult for the breast tissue behind the implant to be seen clearly enough. This might be a particular concern for women at high risk for developing breast cancer, such as women with a strong family history of breast and/or ovarian cancer. That said, the current data suggest that neither silicone nor saline implants are associated with an increased risk of breast cancer. Either type of implant can have complications, however, such as decreased nipple sensation, pain, unattractive appearance, scarring, infection, or rupture of the implant. (Dr. Martee L. Hensley)