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TURNED DOWN BY INSURANCE FOR REPLACEMENTS

OR EXPLANT ONLY?

DON’T GIVE UP JUST YET! BY PATIENT ADVOCATE: BARBARA STOCK

415 Kilshore Lane, Winter Park, FL 32789 E-Mail: brstock@....

DISCLAIMER "The author, the Plastic Surgery Network, Inc. or its employees do notguarantee the accuracy of any material contained here. However, every efforthas been made to obtain information from sources believed to be reliable. Inreading this, remember the author is not a physician. You should consult aPlastic Surgeon or other healthcare professional if medical advice is neededor an attorney for legal advice. Any opinions expressed are solely those ofthe author, Barbara Stock."

I want to help you, the surgeon, or your patients obtain approval from any insurancecarrier! In the past 2 1/2 years, a woman won against Nationwide at a jurytrial for reimbursement of the cost of replacements plus explant. Numerousothers have filed suit against their insurance companies; obtaining paymentfor at least explant . TO THE PATIENT; DO NOT CALL YOUR INSURANCE COMPANY! They often discourage you; the fewer claims paid, the more money they make. Obtaining two letters of medical necessity will normally not be sufficientunless they document one of the conditions described here. The source of the following information is from aiding more than 200 women obtain insurance approval over the pastseveral years. Read this carefully. Take it with you to show your PlasticSurgeon (P/S) just in case he has not recently visited this Website. Mosthave been kept in the dark like we have by the insurance companies. To theP/S, if a third party pays for part or all of a popular procedure, you willsoon find it good for your business. I am only an E-Mail away to answer anyquestions you have! Replacements and explantation are normally paid for when done forreconstruction. If done prior to 6-1-93 for cosmetic augmentation, onlyexplant will probably be paid. Both are dependent on one of the criteriadiscussed here being met. Reconstruction is, for example, after a mastectomyfor breast cancer, a birth defect such as Poland’s Syndrome, etc.Differences in the size of the breasts normally is seen as solely cosmetic and is notcovered. In Chandler vs Nationwide, the Plaintiff’s original implantation was donefor augmentation. She won coverage for her replacements and explantation at ajury trial. She was able to obtain legal representation because she had anindividual policy covered by state law. Those obtaining their insurance through their employer, their spouse’s employer or still in the time period of COBRA, are covered by ERISA, a Federal law. ERISA severely limits the ability of the policy holder to sue. Many times, an insurance company will try to bluff by saying they will not pay for explantation because it is a “complication of plastic surgery.” My breast implants were removed after 20.5 years. Complications from my surgery would have occurred long before then. The right implant was ruptured; it was a defective product. The brochures of the manufacturer indicated at the time they would probably last a lifetime. They gave little indication of any complications. Arguing with your insurance company for saline to replace silicone-gel or for explant only on the basis of an autoimmune disorder or systemic disease at this time is not worthwhile. They do not feel any connection has been proven. I believe breast implants can cause systemic disease. I advise concentrating on local problems, such as documenting a rupture or being examined by a P/S to substantiate other covered conditions explained here. Reality is these are the only reasons for approval, at present. A rare exception might be someone with an individual or privately obtained policy who cannot document enough local problems to obtain approval. The company might capitulate, if it believes it will shortly be sued. Some patients can benefit from a mastopexy or breast-lift. Only on the rarest of occasions, have I seen an insurance company pay for this. If you are contemplating having this, ask your P/S for the American Society of Plastic and Reconstructive Surgeons (ASPRS) booklet on this procedure to read carefully. For those with breast implants for augmentation done after June 1, 1993, your insurance company can say you had full disclosure on the possible complications. Also, the opportunity to learn more about the possibilities from a variety of sources, if you took the time and effort. This has merit. Before that, information was hard to come by. The insurance companies feel you have accepted the responsibility for any complications that result. A search under “BREAST IMPLANTS” on the Internet reveals a wide array of sources available. I steadfastly argue for those who were implanted before June 1, 1993 whether they have saline, silicone-gel or double/triple lumen; they should have coverage for at least the explant. Insurance companies will not pay to explant a deflated saline implant (augmentation) on the supposition it does no harm. If the remaining silicone shell of a deflated saline implant has become encapsulated to the extent it is Baker IV described below and implanted prior to 6-1-93, your insurance company will probably pay for explanting it but not replacement. If only one silicone-gel implant is documented to be ruptured to the insurance company’s satisfaction prior to explant, they often will grant approval for only that one. However, that might be approximately 2/3rd of the cost of explant; not 1/2. Check with the business manager of your P/S how this works. I give you and your P/S plenty of ammunition to argue for approval for explant of both; keep reading! Coverage is usually granted for BAKER IV CONTRACTURES (hardened capsules interfering with a mammogram with breast pain a necessity), for augmentation and BAKER III CONTRACTURES, for reconstruction. Also, RECURRENT BREAST INFECTIONS, BREAST CANCER, if it interferes with treatment, EXTRUDING or COMIN G THROUGH THE SKIN, an OPENING WHICH HAS NOT HEALED exposing the implant or DR AINAGE (not minor) that breaks through, usually at the scar, again exposing the implant. Lab tests might indicate there is no infection. The key is the implant is probably exposed by the opening for the drainage. If a patient has a RUPTURE of silicone-gel, a universal reason for coverage, it should be stated in the operative report; not a “tear” or it was “disintegrated.” Remember, an inexperienced person might be looking at the carrier’s guidelines. Unless they see the “magic words” they recognize, they might turn down the request. Also, the P/S should state Baker III or IV; instead of “Grade 4” or “severe contractures” for the same reasons. If the request is turned down, the patient should request a copy of the Office Notes. If you have one of conditions listed here, see if it is clear when you read it. If not, contact your P/S. A radiologist who reads a MRI or Ultrasound beforehand should say, if he believes it,, “There is a 60% to 70% chance the right implant is ruptured, not “possible rupture,” which the insurance carrier will normally turn down. The P/S must make the request for preapproval. He might consider calling the radiologist to ask himto amend his/her report, if he has said only “possible rupture” (Ultrasound or MRI Report only). A mammogram will detect, as a general rule, only those ruptures where the gel has spread beyond the scar tissue or capsule. It will not normally detect those which are intracapsular or are being contained by the scar tissue/capsules. Intracapsular ruptures account for 90% to 95%. Imaging such as an Ultrasound or MRI are not indicated to detect a rupture of a saline implant. With saline implants, you promptly know if there is a rupture; the breast size decreases. The first choice of imaging to detect a rupture is usually an Ultrasound. It is much less expensive than a MRI. It might detect a rupture only 50% to 70% of the time. Sending a patient for a bilateral MRI in an attempt to document a rupture might have the probability to detect one increased by 10% for one with a breast-coil and by requesting the same radiologist read the film consistently. However, even an experienced radiologist with a MRI with a breast-coil can miss perhaps 10% or more of ruptures. About 50% facilities now have a breast-coil. If there is not one locally, then traveling, for example, up to 100 miles to where they do have one might be worthwhile. This is if the patient does not have another condition for which approval might be obtained. If the patient obtains preapproval, she does not have to worry about a possible complication running up a large bill she might not be able to pay or having to raise the cash. In the Orlando, FL area where I live, there are four MRI machines within ten miles of each other equipped with a breast-coil. If no apparent rupture is detected at explant or identification for the Settlement cannot be made in any other way, the patient may have her implants sent directly by the pathology department to someone who specializes in this. The local pathologists, as a general rule, will only identify any rupture they can see from a “gross examination.” They often do not exam the implants for exuding gel by gently pressing on each as it rolled to detect smaller openings. The P/S usually does not have the time as the next patient is probably already under anesthetic. I suggest Dr. Saul Puszkin (1-212-342-7272). The cost is perhaps $250/$300 for examination and for it and manufacturer identification, probably $400/$450. If the implants are to be sent for an outside examination, I advise that the patient not take possession of them until after the exam takes place. The insurance company could claim possible tampering. The pathology department will need a letter from the patient directing them to do this and a check for the overnight charges. They should enclose a letter with the implants stating her name, address, telephone and Social Security number, date of birth and enclosing a copy of the operation and pathology reports. The letter should state the implants are being sent directly establishing the chain of custody with a copy sent to the patient. Normally, the pathology department or P/S, if done at his/her facility, should hold the implants for 30 days unless instructions are given otherwise. It is the responsibility of the patient to confirm ahead of time with the applicable pathology department for the facility where the surgery will take place or if at the P/S’ office, her instructions in regard to whether she wishes her implants retained so she can pick them up after her surgery.

To the patient; if the manufacturer of your implants is unknown and you have registered for the MDL Settlement by 3-1-95 or opted-out and hopefully, also for Dow Corning’s Bankruptcy by 1-15-97 and your P/S and local pathologist cannot identify who made them, you may also retain Dr. Puszkin for this purpose. I have no financial association with him whatsoever. Dow Corning made the gel used to fill the implants of many of the other manufacturers. Verifying a rupture of silicone-gel had to be received by 12-16-96 for those opting into the Revised Settlement (Baxter, Bristol Myers & 3M). Dow Corning will probably be offering a rupture bonus also. For insurance approval, if it could not be obtained prior to surgery, and for those with Dow Corning implants being explanted, verifying a rupture or opening, if one exists, might be important. Any opening, even a pin hole, is legally defined as a rupture. Because of the high rupture rate, it is probably worthwhile to have any silicone-gel implant examined further which are 8-10 years or older (maybe less depending on any symptoms), if no overt rupture was detected. Any possible damage done at explant should be enumerated in your operative report which you can obtain approximately within one week after your surgery. Discuss it with your P/S, also. Mentor and Bioplasty have already settled with recipients of their implants who were eligible. CUI refuses to provide any help to their recipients on the supposition they are financially unable to do so. Silicone-gel from 8-3-84 to 12-31-91 are covered by the Revised Settlement. Questions as to what to do with the implants after explant, proving a rupture and identification, can be answered by the Legal Assistance Office at 1-513-66 5-9770, if you have no attorney. Or, by calling your attorney for the Settlement. It is important to ask the patient if she has a burning acid pain; a symptom of a rupture of silicone-gel. The patients often do not know how to describe this. Or, stabbing pains in the breast which come and go and if it predominates on one side. Also, any difference in volume in each breast, if originally the same approximate size. If each implant is gently squeezed from the bottom, sometimes a ruptured silicone-gel one will elongate and extend towards the collar bone or axilla. A picture of this phenomena might be taken to include with the request; particularly if an Ultrasound and/or MRI fail to document a rupture. Most policies only permit one appeal or two opportunities to win pre-authorization. If these fail, the woman will have to pay for the surgery and then submit the bills afterward with any additional documentation. If you are the patient and do not already have your original records when you were implanted, please write the physician who did the surgery to send you a copy, including the Product Identification Tag showing who the manufacturer is. The request is normally required in writing and you should give the date you were implanted, your name at the time, date of birth and Social Security number. If the implanting P/S does not have your original records and the surgery was performed at his office, ask him to look up and write you a letter as to the manufacturer, Catalog and Lot Numbers and cc’s the implants originally weighed, from his surgical log. This information will be contained on the Product I. D. Tag , if it is available. If you were implanted at the hospital, this information can be obtained from their surgical log, in addition to your operation and pathology (if applicable) reports. The hospitals may have a charge; call first to see. Ask for the medical records department. If you cannot locate your implanting P/S, call the ASPRS at 1-800-635-0635.. Obtaining your records is helpful to the P/S, if other than the implanting one. Also, if you have had a mammogram and/or breast MRI in the past few years, please obtain the film, if possible. If you are having explant only, this for one will help the P/S give you an estimate of how he thinks you will turn out looking like. Mine said I would probably be a B cup and look great in a Wonderbra. He was right. I also did not need a breast-lift. You may obtain a summary of an article,“AESTHETIC OUTCOME OF BREAST IMPLANT REMOVAL IN 85 CONSECUTIVE PATIENTS” from the July, 1997 issue of the Plastic Surgery Jounral available from http://www.wwilkins.com/PRS/. It is also important for the P/S to note the date implantation and age of the implants. An article in the ls of Plastic Surgery, January, 1995, “ANA LYSIS OF EXPLANT SILICONE IMPLANTS: A REPORT OF 300 PATIENTS,” shows on the fifth page, at eight years one or both are ruptured or severely leaking (gel will extend 12” or more indicating a pin hole), in 21%, twelve, 49%, fourteen, 71% and twenty years, 95.4%. You will note the rate accelerates from 8 to 14 years of age meriting preapproval at or before eight years old, in my opinion. However, this is not the way at present it works with the insurance companies! This article mentioned states of the 592 implants removed, 63.5% had disruption. Disruption was found to be directly related to the age of the implants. The complete article that appeared in the Canadian Plastic Surgery Journal in the spring of 1996, “FAILURE PROPERTIES OF 352 EXPLANTED SILICONE-GEL BREAST IMPLANTS,” can be obtained from their Web Site; http://www.pulsus.com/p lastics/home.htm. This article discusses 1st, 2nd and 3rd generation implants. Also, to the P/S, see a letter in the July, 1997 issue of the Plastic Surgery Journal on pages 281-283, summarizing the rupture rates of 1652 explanted breast implants. The older or the first generation of implants, which had thicker shells, generally those implanted during 1972 or before for Baxter (Hyer-Schulte) and Bristol Myers (Surgitek) and 1975 for Dow Corning, probably have a lesser rupture rate; 50% from my experience with approximately 30. The Canadian Plastic Surgery Journal article reports of 18 first generation implants removed, all were in tact. Mine and theirs are small sampling. However, the older implants often become calcified and with hardening or capsular contracture, since this interferes with a mammogram and often results in breast pain, they should probably be replaced or explanted. If a patient has Baker IV contractures, the P/S should dictate in the Office Notes to be submitted with the request, that this might obscure breast tissue or interferes with a mammogram. Also, the breast pain as the patient describes it and any other details. Explain the condition clearly the patient has that ASPRS considers medically necessary they be explanted. If a new person is doing the review, not realizing what is considered medically necessary might cost the patient approval. Some companies’ internal guidelines go into great details; others are brief. Every policy covers that which is “medically necessary,” unless preexisting or some other special case. I know it is the opinion of some in the Plastic Surgery community a ruptured implant might not do any harm, if it is contained within the capsule. However, I know a psychiatric R. N. who had the capsule and/or implant rupture with extrasavation of the gel into her breast tissue and axilla, by a patient who hit her. Dozens have ruptured by automobile or other accident, th ree I personally know of by compression from mammograms, etc. The consequences for long-term of silicone-gel in tissue is not known. For this reason, the FDA says, “If a gel-filled implant has ruptured, it should be removed. Signs and symptoms of rupture may include breast pain, tingling, numbness, burning, changes in breast size or shape and changes in sensation.” Another possible reason for approval is a family history of breast cancer (grandmother, mother, aunt and/or sister). The implants can obscure part of the breast tissue during a mammogram. With a family history of breast cancer, the patient might have a 50% greater chance of having breast cancer. Or, Atypi cal Chest Pain (so severe as to mimic a heart attack; Southern Medical Journal, January, 1996, Vol. 89, No. 1, page 97), with no underlying heart problem found after thousands have been spent to rule out a heart attack. If the patient can provide them, submit her medical records and bills showing the expense to rule out she was not having a heart attack and state how many times this has occurred. Also, the P/S should mention this can reoccur but usually does not once explant takes place. A Medline or search of the medical literature reveals 13 articles on this in the past three years; “Breast Implants Chest Pain.” If replacements are planned, the above arguments cannot be used. Unfortunately, Champus will not pay for explant, if implantation was done for augmentation. They will pay for it normally, if done for reconstruction and the patient fits one of the guidelines already discussed. However, if it is the patients 4th or 5th replacements, they might refuse saying, “The patient should have figured out it would not work.” This is so dumb that it does not merit any comment by me! Contact your senators and representatives to change Champus’ policies! Also, those who are active military or their spouse is, if the patient fits the guidelines enumerated, they will, usually, have a P/S consultant perform the surgery at their facility or send them to one which has a P/S. You may do a free Medline or search of all the medical literature under “Breast Implants Ruptures,” “Breast Implants Saline,” etc. at http://www.heal thgate.com. If you are in an automobile accident resulting in trauma to your breast(s) with symptoms of a rupture occurring shortly afterwards, be sure to tell the doctors attending you. See your P/S as soon as possible. Your Personal Injury Protection and/or Medical Insurance, if any, on your auto policy or the insurance of the person at fault might pay. If the patient has explanted after 4-1-94 at least one Baxter (Hyer-Schulte), Bristol-Myers (Surgitek/Medical Engineering) and/or 3M (McGhan before 8-3-84) implant, registered for the MDL Settlement before 3-1-95 and opted-in, there are approximately 100 major insurance companies who have agreed they will not ask for reimbursement from any proceeds from the Revised Settlement. They can from the $3,000 explant benefit. I do not know any that have done so which is probably because it is a small amount (to them). The list is at back of the Q & A, 1-28-97, that came with the Notice of Status. Anyone may request a copy of this by faxing 1-713-951-7010. The list only includes commercial insurance carriers and not Medicare, Medicaid and/or Champus. The $3,000 for explant can be assigned to the Plastic Surgeon who does the replacements or explant. Some insurance companies have a clause that precludes coverage for anything in regard to breast implants. I think these are unenforceable. I am hoping a woman with an individual policy will come along to challenge it! These women should file a complaint with the Insurance Department. Often those approving a policy with the Department see this as elective surgery and do not know “the whole story.” For example, it is not considered “elective” to remove a ruptured silicone-gel breast implant. It is widely considered medically necessary. It is up to us to see they are advised of the facts; show them this write-up! If a woman wins who has an individual or privately obtained policy, since the insurance company has to pay her attorney, she normally keeps the entire award. The bad point is the vast majority of attorneys who specialize in insurance will only handle those with individual policies, those converted after the time period for COBRA ran out (18 months or for those applying for Social Security Disability/SSI, 29 months) and sometimes for those who are self-employed with no employees, even though technically a group plan. The attorney needs to be assured he will ultimately be paid for his time, if you win. Individual policies or those just described, are in state court which usually have a good track record for awarding fair attorney’s fees. Those obtained through an employer or under COBRA are in Federal Court which rarely awards fair attorney fees. I sued Aetna for failure to pay for my explant and recently settled out-of-court. I signed a “gag order” so cannot disclose the amount. I converted my policy obtained through an employer after the time period for COBRA ran out to an individual policy. My attorney also represented Chandler against Nationwide mentioned earlier. If you have an individual policy as described and are denied coverage for replacements/explant, contact me for my attorney’s name and phone number. E-Mail: brstock@... or write Barbara Stock, 415 Kilshore Lane, Winter Park, FL 32789.

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