"Micheline B. Lambert" <email@example.com> Wed, 30 Jun 1999 18:20:02 -0700
To All Of You, This Letter is at the following add: http://www.geocities.com/HotSprings/8689/letter.html It is impossible to be printed the way they posted it. The Canadian Connection A MUST! LETTER TO SEND THE PATHOLOGY FIRM BEFORE EXPLANT If you are going to be explanted, IT IS A NECESSITY to send letter similar to the following to the pathology department of the facility: (1) If you have Dow Corning silicone gel implants, (2) You have not or have been unable to obtain Proof of Manufacturer (3) Have Opted-Out, or (4) If you have silicone-gel and have not obtained insurance preapproval prior to explant! Others, consult your support group leaders and/or attorney to see if they think it is necessary in your case. By NOT sending a letter prior to explant, IT COULD COST YOU UP TO $25,000.00, the amount for the rupture bonus for the proposed Dow Corning Bankruptcy Settlement, if you are having Dow Corning implants removed, or do not know who manufactured your implants and it turns out they are Dow Corning or maybe even more, if they are by a manufacturer filled with Dow Corning gel. READ FURTHER! If you are being explanted at a free standing same day surgical center or the operating suite of the P/S, please ask which pathology firm will be picking up your tissue and implants for the report. Then call this pathology firm to make sure they still do the pathology consultations for this surgical center or P/S. We are amazed how many of the P/S and free standing same day surgical centers do not realize who the pathologist is for procedures done in their operating room suite. This might have been changed by their office manager without them realizing. Your implants and capsular tissue could end up across town or the country. It is not the responsibility of a P/S struggling to help us (doctors are often poor at details so even if they say they will contact the pathologist, do not count on it!) to make sure the pathologist is notified of your wishes. Also, the P/S usually does not have time to carefully examine your implants for a rupture after removing them as frequently his next patient is already under anesthesia and he must quickly go on to that person. And do not assume just because your explanting P/S is famous for helping us, he has this all worked out with the pathologist. The pathologist is independent of him. The day of your explant, a brand new one hired by the pathology firm could be handling your pathology report who does not realize what is important to do! At the very least, you need to write to have your implants saved so you can pick them up within 30 days after explant. If for any reason, you cannot pick them up in this time period, the letter tells the pathologist you will contact him so they will continue to hold your implants. If the pathologist says they can only be released to your attorney or some such, discuss this with your P/S. Your breast implants should be retained indefinitely should you ever need to have them analyzed because of medical problems (such as what chemicals were in yours). Even if you have the Product I.D. Tags for your implants giving the Lot and Catalog numbers, the records of the manufacturers have proved to be far less than perfect as to what chemicals and how much went in each lot. Breast implants have been in use only since 1964 and not widely until the 1980s. It is estimated 60% were implanted from 1986 to 1992. Silicone gel were banned by the FDA for augmentation with a few exceptions in 1992. The majority have only been implanted for 6 to 12 years, with an average of perhaps 9 years. We have no idea what the long term will hold. A medical journal article reports the latency period is a median of 37 years with a range of 10-68 years, for cases with occupational asbestos exposure before they developed malignant mesothelioma associated with it. Asbestos was manufactured starting in 1858 and no one complained up until the early 1980's or for 127 years. The local pathologist have for the most part, done nothing but glance at the newly removed breast implants and unless there is a gross rupture, they examine them no further for a small opening. This has cost us tens of millions of dollars in funds from the rupture bonuses being paid by the manufacturers for good reason. It is time it came to a screeching halt by asking for a thorough exam (by requesting it in writing prior to explant) for any opening, including pinhole. Any opening in the elastomer shell is defined as a rupture; that is the legal definition given under the Revised Settlement and the proposed Dow Corning Settlement. The pathologists are doing a more thorough exam across the board when they receive the letter shown below! Women have reported their pathology reports enumerated their implants being gently rolled with mild pressure to look for a small or pinhole opening. All but one was found even though there was no obvious rupture. If you have opted out, be sure your attorney is aware of your approaching explant. He might wish to have the tissue and implants sent to a pathologist who has more sophisticated equipment than is available locally. Most local pathologists do not have the necessary equipment to affirmatively identify silicone and can only guess whether it is or not, which might not hold up in court. In any event, he probably will not want you to ever touch the implants because of the chain of custody (you could take an ice pick to them!) and store them or have some pathology firm he has retained do so. Your medical insurance carrier will only pay for the pathology report being done one time. The facility will usually require that the pathologist on sight, or in the case of a free standing one or at the plastic surgeon's office, the report being done by the one they have chosen. Unless you have opted out, paying perhaps $950 for a pathologist with the necessary very expensive equipment, is a nicety and perhaps not a necessity. You should instruct the pathologist (by certified mail with a return receipt, if hand delivered with a copy signed and dated, or by overnight delivery) to examine them for ruptures or pinholes and to keep your implants at least 30 days so you can pick them up, do not expect them or a thorough examine to be done for a small opening. If pressed for time, you can have a relative or friend who accompanies you for explant hand deliver a copy of the letter to the pathologist once you are taken into the operating room and have the employee of the pathology firm receiving it make a photostat showing and sign, date and the time it was received and give that back as a receipt your instructions were received, if they are on site. If you have been unable to obtain proof of manufacturer, below are the identifying characteristics that you should print-off to give your P/S and send with the letter to the pathology firm. If any of these "identifiers" are enumerated in the operative and pathology reports plus photographs made of the implants (P/S usually willing to do this), this might be sufficient for proof and save you the $300 plus overnight shipping charges to send them to an expert specializing in identification of the manufacturer. Also, see the article, HOW TO OBTAIN PROOF OF MANUFACTURE, at this site. If you are using one of the P/S frequently suggested by support group members, in as high as 90% of the cases, they will be able to identify your implants. Also, they are good at obtaining insurance Preapproval and for producing good cosmetic results with explant only and no replacements. These P/S will also endeavor to remove your implants "en bloc," with the capsule and implant as one unit. This procedure automatically includes a total capsulectomy. By cutting around the outside of the capsule, the capsule helps hold any gel together from a rupture or gel bleed, until both are out of you. If your explant is not done properly, you could be worse off then you already are. See the write-up on how explant should be done at the COALITION OF SILICONE SURVIVORS: http://www2.privatei.com/~coss/coss/sshead.html For a list of suggested P/S', most of which are famous for helping us and/or for a suggestion of an attorney if you live in the U. S., E-mail: Barbara, Sursiliimp@aol.com. For further help and support, E-mail Ilena at firstname.lastname@example.org and ask to be added to her post list so that you automatically receive the latest medical and legal news on silicone implants before the ink even dries on the articles. You are not alone. NOTE: IF YOU ARE HAVING SALINE EXPLANTED, PLEASE ADAPT THE LETTER ACCORDINGLY! PATHOLOGY DEPARTMENT XYZ HOSPITAL 1414 S. Whatnot Street Anytown, CA 99999 CERTIFIED RETURN RECEIPT#_________________________ OR AIRBILL# IF BY OVERNIGHT DELIVERY OR FOLLOWING IF HAND DELIVERY: ACCEPTED BY (EMPLOYEE OF XZY PATHOLOGY FIRM) SIGNATURE______________________________TIME__________ PRINT NAME_____________________________DATE__________ RE.: Your Name_______________________Social Security#___________________ Date of Birth_____________Date Surgery:_______________________ Plastic Surgeon:_________________________ Gentlemen: I am being operated on by_________________________, M. D. (D.O.), at approximately _________on (date)__________, to remove my breast implants and capsules, at the same day surgical center (hospital or Plastic Surgeon's in office operating suite) above. 1. Please save my removed breast implants. I will pick them up within 30 days afterwards or give you further instructions in regard to them. 2. Please weigh my implants and place this information in the pathology report. It is an important medical fact how much they weighed when explanted as most of us know having obtained the original Product I. D. Tag how much they weighed when implanted. For the gross examination, I appreciate you recording the type of external surface, i. e., smooth, textured, polyurethane or smooth and covered by sticky material and contents of the implant, i. e., viscous gel, oil or watery fluid. Please note the color of the gel; at implantation as you know it was crystal clear. Now it might be yellow. 3. Please also note any inscriptions, including brand name, size and/or serial number present on the elastomer shell or any identifying characteristics. I was implanted with the present set, on_____________or over______years ago. (For those who have been unable to find proof of manufacturer; please add this: I have been unable to find proof of who manufactured my implants and would so much appreciate you listing any of the "identifiers" you see on the elastomer shell which are attached to this letter.) 4. If there is a rupture, please use that word in your report. The definition of a rupture is usually any opening in the elastomer shell. Pathologist have used the term "opening in the capsule" which led to much confusion instead of saying "opening, pinhole or rupture in the elastomer shell or envelope." The capsule is generally referred to in medical circles as the scar tissue surrounding the implant. Using a word like puncture indicates it was caused by the surgery when it might not have been. If damage to the implant occurred during the surgery, it is up to the explanting physician to note that in my operative report. If the outer shell is focally ruptured (describe the size of the rupture and whether gel extrudes significantly), if completely disrupted with fragmentation of the outer shell (in case saline: completely deflated and flat), small or pinhole opening and approximate size, etc. 5. If no gross rupture(s) of my breast implants is observed, carefully examine each by slowly by gently rolling them with mild pressure, to see if a pinhole or small opening in the elastomer shell can be spotted. This I consider pertinent information for my health care professionals for the long-term. Also, any opening, as mentioned, legally qualifies as a rupture and might qualify me for substantially more funds from the Settlement I need because of my declining health. 6. Please note if you see what might be metal or dark floating particles or objects in the silicone-gel (saline). 7. For SALINE only: There were no drugs instilled in the saline solution when my implants were placed or there was bedatine, cortisone; antibiotics -- see your operative report at implantation and Office Notes; help the pathologist -- give him the facts! If the saline solution looks like "swamp water," since no drugs were instilled (if true), you might have cultures for a more lengthy time to identify what is growing in it. Microorganism growing in the saline solution now are documented to occur more frequently than previously thought. (Don't type this in the letter; run off the articles, if you are having saline explanted, in article #21 at the SALINE IMPLANT LIBRARY and attach those to your letter: http://www.GeoCities.com/HotSprings/8689/saline.html 8. Please note the presence and character any inflammatory reaction, description of foreign material if present, i. e., silicone appears as refractile, non-birefringent, optically clear material often found within macrophages. Any giant cells with vacuoles you see, I would appreciate you mentioning, etc. An article and a multitude of others, from Annals of Plastic Surgery, January, 1995 on 300 patients who had 592 silicone-gel breast prostheses explanted, states there is a 21% chance of one or both are ruptured or severely leaking (the gel will extend 12 inches which indicates a pinhole or small opening exists) at 8 years old, 49% at 12 years, 71% at 14 years and 95% at 20 years old. (Only for those with silicone gel) Please be sure to note if there is granulation tissue, silicone granulomas on the exterior of the biological capsule, lymphocytes, foamy histocytes, macrophages, mast and/or multinucleated giant cells, plasma cells, eosinophils, foci of epitheloid cells and fibroblasts, everything you see that might be considered a foreign body or immune reaction or fluid between the capsules and implants, synovial metaplasia, etc. There are also increasing reports of squamous cell carcinoma in the capsule surrounding a breast implant. I need your help again to please note everything when doing my Pathology Report. It might help my health care professionals in treating me over the long-term. Thank you so much for your efforts on my behalf. Sincerely, X__________________ MARY JANE DOE Enc.: Subclinical Infections, Synovial Metaplasia and Squamous Cell Carcinoma Associated with Breast Implant Capsule. Note: The above articles are after the list of Characteristics below; you can copy and paste them into your word processing program plus the requirements for proof of rupture from the proposed Dow Corning Bankruptcy Settlement and the "identifiers," for all of the manufacturers, if you still in need of proof of manufacturer and then print them off to attach to your letter) PROOF OF RUPTURE REQUIREMENT DOW CORNING: (e) Rupture Payment Option. To qualify for the Rupture Payment Option a Breast Implant Claimant must meet the requirements listed below: (i) Definition. "Rupture" means the failure of the elastomer envelope(s) surrounding a silicone-gel Breast Implant to contain the gel (resulting in contact of the gel with the body), not solely as a result of "gel bleed", but due to a tear or other opening in the envelope after implantation and prior to the explantation procedure... (iii) Rupture Proof. ...Breast Implant Claimants explanted after January 1, 1992 and before the Effective Date must submit a contemporaneous operative report and, if available, a pathology report together with a statement as to whether the ruptured implants have been preserved and, if so, the name and address of the custodian. c. 1. Breast Implant Claimants explanted after the Effective Date (probably June/July) must submit a contemporaneous operative report and, if available, a contemporaneous pathology report. In addition, the Claimant must provide a statement from the explanting surgeon (or other appropriate professional approved by the Claims Office) affirming that, in his or her opinion, the Rupture did not occur during or after the explantation procedure. This statement must describe the results of the inspection and provide a factual basis for the opinion (e.g., in light of silicone granuloma formation on the exterior of the biologic capsule, or findings concerning the nature of the destruction of the elastomer envelope). The Claimant shall use her best efforts to cause the removed implant to be preserved... LIST OF CHARACTERISTICS UNIQUE TO SPECIFIC MANUFACTURERS OF IMPLANTS BRISTOL-MYERS 1. Polyurethane (for implantations before 9/1/71 or after 12/8/78) 2. Bilumen implants described as having a standard gel implant within, but not attached to, an outer inflatable elastomer shell. 3. An implant having an SSI valve. An SSI valve can be mentioned by name, or by description: a circular valve that looks like a button, having a slightly rounded dome. It is Dacron-mesh reinforced. 4. An implant having a Quin-Seal valve. (This valve is flat and its entry site is marked with a white dot.) 5. An adjustable reconstructive implant with two puncture seal sites (shell and column). 6. An implant with "SCL" molded on the shell. 7. An implant with radiopaque size markers. 8. For implantations before 9/1/71 or after 12/8/78, an implant shell exhibiting roughness due to adhesive can be treated as a "polyurethane" implant even if the foam cover is gone. BAXTER (HEYER-SCHULTE) 1. Polyurethane (for implantations 9/1/71 to 12/8/78). 2. For implantations 9/1/71 to 12/8/78, an implant shell exhibiting roughness due to adhesive can be treated as a "polyurethane" implant even if the foam cover is gone. 3. An implant with horizontal thin silicone tubing approximately 1mm in diameter. The tubing lies from edge to edge of patch for orientation purposes. Ends of tubing are "RTV'd" closed. 4. An implant with a butterfly silicone fixation patch which is perforated to allow tissue ingrowth. The edges of the patch, but not the face, are adhesed to the main patch. 5. An implant with a molded or cast number composed of a single letter A, B, or C and followed by a single-digit number. 6. An implant with a "spiral" or "target" imprinted design composed of concentric rings located on the main patch. 7. An implant with a retention valve positioned at acute angle to flange. 8. An implant with a diaphragm (Jenny) valve placed on the anterior face of the implant. (On round styles, valve will be at apex of the anterior face.) Baxter identifiers 3 - 8 above relate only to implantations before 3/31/84.] 3M (MINNESOTA MINING & MANUFACTURING) 1. An implant with "3M" or "3M McGhan" stamped on the outside of the envelope. Relates to those implants manufactured before 8-3-84 only. MCGHAN 1. An implant with "McGhan" stamped on the outside of the envelope. DOW CORNING: UNIQUE PRODUCT IDENTIFIERS: A photograph of an explanted Breast Implant that shows one of the characteristics unique to a Dow Corning Breast Implant, as specified at Section D, below, if the photograph is accompanied by a statement from the explanting physician identifying the Breast Implant in the photograph as one (s)he removed from the Claimant. I have asked my Plastic Surgeon to photograph my implants once removed. DELETE the following sentence in what you give the pathologist; it is directed only to you: If you need the pathologist to do this, you should call ahead of time to arrange it. If they do not have a camera, even if you have to go out and buy an inexpensive Poloroid one or borrow a camera for them, do so! The following unique product identifiers of a Dow Corning Breast Implant(s) shall be considered as acceptable proof where the removed implants are examined by a physician who identifies the manufacturer or brand. See paragraph 7 of Section B above: 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 Claims Office 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. 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 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. SUBCLINICAL INFECTION OF THE SILICONE BREAST IMPLANT SURFACE AS A POSSIBLE CAUSE OF CAPSULAR CONTRACTURE Author: Virden CP; Dobke MK; Stein P; Parsons CL; Frank DH Address: Division of Plastic Surgery, University of California, San Diego 92103. Source: Aesthetic Plast Surg, Spring, 1992, 16:2, 173-9 Abstract: In order to reexamine the possible association between bacterial presence and capsular contracture, 55 silicone devices (mammary implants or tissue expanders) were cultured at the time of their removal from 40 patients. Special culture techniques were used in an attempt to recover bacteria adhering to the smooth-surfaced implant and encased in glycocalyx biofilm. Bacteria were detected on 56% (15 of 27) of implants surrounded by contracted capsules and on 18% (5 of 28) of those without capsular contracture (p less than 0.05). Only three implants tested positive using routine plating techniques. The predominant isolate was Staphylococcus epidermidis. The concept that capsular contracture is associated with subclinical infection of silicone implants is supported by this study. With changes in the microbiological technique, bacterial recovery and growth occurs at a frequency greater than previously thought. EPITHELIALIZATION OF THE LINING OF BREAST IMPLANT CAPSULE: POSSIBLE ORIGINS OF SQUAMOUS CELL CARCINOMA (CANCER) ASSOCIATED WITH BREAST IMPLANT CAPSULE Author: Kitchen SB; Paletta CE; Shehadi SI; Bauer WC Address: Department of Pathology, St. Louis University Medical Center, St Louis University School of Medicine, MO 63110. Source: Cancer, 1994 Mar, 73:5, 1449-52 Abstract: The authors described a Case in which the capsule surrounding a breast implant was lined by benign squamous epithelium. A second Case, in which a woman was found to have a squamous cell carcinoma in the capsule surrounding a breast implant, was also reported. SYNOVIAL STRUCTURE OF BREAST-IMPLANT- ASSOCIATED BURSAE Author: Emery JA; Spanier SS; Kasnic G Jr; Hardt NS Address: Department of Pathology and Laboratory Medicine, University of Florida College of Medicine, Gainesville. Source: Mod Pathol, 1994 Sep, 7:7, 728-33 Abstract: Over 2 million silicone breast prostheses have been implanted since they were introduced in the 1960s. After implantation, a fibrovascular tissue reaction referred to as a "capsule" is observed. Many consider this capsule to be a static structure, an effective barrier to the egress of foreign material. However, reports documenting the presence of silicone within lymph nodes of patients with apparently unruptured implants indicate that silicone may be transported away from the breast-implant capsule. To characterize the cells making up the breast-implant capsule, 183 capsules from 103 ruptured or bleeding implants and 80 intact implants were studied. Gross and light microscopic studies were performed on all, and selected capsules were subjected to ultrastructural study and Fourier-transform infrared spectroscopy. Light microscopic examination of the capsule revealed an organized, layered structure with an associated network of endothelia-lined spaces. The capsules varied in cellularity, depending on the type and integrity of the implant. The superficial cell layer of all capsules had cytoplasmic processes directed toward the surface. These long cytoplasmic processes contained vacuoles ultrastructurally, indicating phagocytic and pinocytotic capability. These cells bore immunological markers of bone marrow derived macrophage-type cells. The extracellular matrix of the surface layer consisted of an amorphous fibrillar protein lacking the ultrastructural periodicity of mature collagen. No cell-to-cell junctions were observed. Deeper capsular layers were characterized by fibroblast-type cells in a collagen matrix. No capsules studied contained basement membrane or basal lamina between the stroma of the capsule. THE BELOW IS ONLY FOR YOUR BENEFIT AND IS NOT TO BE GIVEN TO YOUR P/S & PATHOLOGIST WHO ALREADY HAVE GIVEN ENOUGH TO READ! (b) Definition of Minor Deficiencies in Rupture Proof. There are four minor deficiencies in Rupture proof. If a Breast Implant Claimant's Dow Corning Breast Implant was removed before the Effective Date, the Claim has a minor deficiency if the Breast Implant Claimant failed to state whether the ruptured implant has been preserved and, if so, the name and address of the custodian. If the ruptured implant was removed after the Effective Date (probably June/July, 1999), the Claim has a minor deficiency if the Breast Implant Claimant failed to provide the Claims Office with the required statement concerning preservation of implants or failed to provide a statement >from the explanting surgeon (or the hospital pathologist, a physician who assisted in the explantation surgery or from another doctor who examined the removed implant, as provided herein) affirming that, in his or her opinion, the Rupture did not occur during or after the explantation procedure and providing a factual basis for that opinion. Note: If you have an attorney, he will be able to tell, hopefully, whether this is necessary to obtain as frequently, the P/S puts this statement or the equivalent of it in the operative report. If it is not sufficient in the operating report, your attorney will write the P/S for you. Also, you have two years we believe from the effective date to be explanted unless because of your medical condition, you probably would not make it through explant, to have your breast implants removed to prove a rupture. See the section on Proof of Rupture on the medical conditions and then how a rupture would need to be documented if you feel you could not make it through the surgery. If the Claimant was explanted after January 1, 1992 but did not submit a pathology report or indicate that the pathology report was unavailable, the Claim has a minor deficiency that can be cured by submission of the report or the required statement. If the Claimant timely submitted the supporting documentation demonstrating Rupture but did not submit a Rupture Payment Option Form, the Claim has a minor deficiency which can be cured by submitting the Rupture Payment Option Form. Breast Implant Claimants may cure deficiencies in Rupture proof by sending to the Claims Office the appropriate written statement, clearly marked at the top as Rupture Proof.