Breast Implant Reconstruction Instructions For Before And: Fill & Download for Free

This is a hot button issue and you will find some disagreement among plastic surgeons, but our thought leaders believe we should follow the advice of the FDA.I am able to give you a forty year perspective.Let’s look at this more closely. Textured implants have been used in some form beginning in the late 1970’s. They were saline devices covered partially with polyurethane foam. they were developed by dr Frank Ashley chief of plastic surgery at UCLA with help from Roger Salisbury a former Dow engineer and silicone expert. The purpose of the foam was to break up the smooth layer of scar or capsule that forms around any smooth device. Collagen is linear in these capsules and have a tendency to contract over time. These early devices were never popular until the mid 80’s when Mr Salisbury developed unique devices called the Meme and the Replicon. These were the first shaped silicone gel devices covered in polyurethane foam and remarkably offered a silicone gel interior that was considerably more cohesive than the existing oily silicone gel available. They were widely popular, because of the lack of capsular contracture and the more natural shapes that were now possible. In an effort to simulate the polyurethane cover, another major player in the implant market was Don McGhan another former Dow engineer. To bypass the patented polyurethane, he mimicked the textured surface by using a lost salt technique. Again these were very popular and the majority of plastic surgeons were moving toward a textured surface by the early 1990’s.By 1992 however, there was a growing concern for all silicone breast implants. Dr David Kessler then chief of the FDA determined that a moratorium would be stay in effect until the companies could prove the safety of silicone gel. They left saline implants on the market. The concern was not ALCL (anaplastic large cell lymphoma) because a case had not yet surfaced. The concern was women’s health in general as many were reporting disease states that occurred after the placement of implants. It was then called Human Adjuvant Disease. Interestingly it was described with all silicone and saline devices but the FDA allowed the continued use of saline—smooth or textured. The illnesses being reported were collagen vascular diseases such as scleroderma, rheumatoid arthritis, Sjogren’s syndrome, chronic fatigue syndrome, and hair loss for the most part.As part of that decision in 1992, polyurethane foam was no longer permitted due to a potential carcinogen from its surface. Polyurethane foam however was still being used in Europe and Asia until quite recently. Polyurethane carries a considerably higher risk of ALCL than the re-called Biocell surface from Allergan. Polyurethane has not been available since 1992 in the US and unless your implants are more than 27 years old it is highly unlikely that they are.By the late 1990’s the first few cases of ALCL were reported but no one associated the disease with the textured surface until retrospective analysis. The FDA and the NIH were charged with determining the safety of breast implants. 10’s of thousands of patients were enlisted in studies at many well respected institutions across the US.After 15 years of studies and meta analyses, the FDA in 2006 came to the conclusion that there was no cause and effect relationship. Women are the victims of all of the reported illnesses by far and women are the recipients of breast implants. In other words: True, true and unrelated. This gave the green light for the manufacturers to reintroduce silicone gel textured and untextured into the market. There is an important phenomenon that occurred. During that 15 years a whole generation of surgeons were using smooth saline devices because the feel of textured saline was too stiff. So, when silicone came back, the next generation opted for smooth rather than textured —-in the U.S.The rest of the world did not follow suit in 1992. Don McGhan with the help of a very savvy plastic surgeon, Dr John Tebbets and later Patrick Maxwell, took his factory to Ireland (no unions, business friendly) and began developing a textured highly cohesive implants in a variety of shapes and sizes. These Biocell surface (lost salt) implants had the advantage of a highly cohesive core working from Roger Salisbury’s playbook as after 1992 Mr McGhan had purchased the patent for the highly cohesive gel. They began use in 1993 in Europe and Asia. Polyurethane was also being used by several other companies including Silimed from Brazil. Few cases of ALCL popped up. The McGhan implants were given the title 410’s which is the style not the size.By 2015 it was coming to our attention that more cases of ALCL were being reported primarily in Australia and some in the US and France. Interestingly at that time there were no cases reported in Asia where these devices were extremely popular. There seemed to be pockets of ALCL from certain locations and not others. This has been attributed to several factors, but the current wisdom is that it is not the surface per se, but rather the biofilm that can hide in this moon crater like surface. The culprit some researchers believe is a gram negative organism, Ralstonia Picketsii. Questions arose as to the irrigation that was recommended by the manufacturers in their instruction for use manuals ( the IFU’s). Due to faulty research, in 1998 the FDA requested that all implant manufacturers prohibit povidone iodine as an irrigant, despite years of experience showing reduced capsular contracture after Betadine rinsing of the pocket (Dr Bpoyd Burkhardt). The concern was that the iodine could be harmful to the integrity of an implant shell. This organism, I am told, will not be reduced by the commonly used triple antibiotic solution (cefazolin, gentamicin and bacitracin). Although logical and deemed effective in some studies, its effectiveness has come under scrutiny of late. Povidone iodine is now used again and the promise is better control of the dreaded biofilms that adhere to the implant shells. In addition, the introduction of the implant was generally directly through the skin incision where the implant would come in contact with the body’s normal flora that could encourage capsular contracture for many years. A huge development a decade ago saw the introduction of a sterile polyethylene funnel known commonly as the Keller Funnel developed by a very clever plasticic surgeon, Gregory Keller. This permits the implant to be extruded directly into the pocket with no contact with the skin breast tissue for the most part.The data is yet to be sorted out in this highly controversial subject. Will povidone iodine or more recently hypochlorite solutions eliminate this risk ALCL? Has the widespread use of the funnel decreased the incidence? Unanswered questions.The perspective I bring is forty years of doing breast augmentation. I have seen all of the problems that have developed from five generations of silicone formulae and design. The textured devices were a major breakthrough in the technology in my opinion. Whether they decrease capsular contracture or not is still debatable but my experience is that they do fulfill this promise. But more importantly they are more stable. By this I mean smooth , round implants (if smooth that means always round because shaped and smooth will flip all over) tend to create problems over time— stretch deformities that cause bottoming out of the implant, lateral displacement far beyond the dissected pocket and more rippling ( although that has been recently addresses with over filled implants but it remains to be seen how they perform in various body types). Textured also brings the advantage of shape. For a woman with scant breast tissue, the appearance of a shaped implant is unbeatable. For women with more breast tissue volume than the implant, it matters little whether they are shaped or round.I would hate to throw the baby out with the bath water. Textured surfaces are here to stay I predict, but they will be modified in coarseness to reduce or eliminate the risk of ALCL . For women undergoing breast reconstruction, especially, shaped devices can be a God send for even with fat grafting to thicken the overlying tissues, there is little to cover these implants and a round implant cannot hold a candle to the results with shaped unless there is considerable thickness of the soft tissue envelope.So that’s pretty much all I have learned over the years. I am a proponent of textured devices and it was wise of the FDA to recommend NO intervention without symptoms—and fear is a response, not a symptom. When the hysteria dies down a bit (and I do not make light here of those women who have suffered the consequences of ALCL), I suspect we will put everything back into perspective. Taking out a textured implant just because it is textured but is otherwise behaving well, should be compared to every woman undergoing prophylactic mastectomies because of a 1:10 risk of developing breast cancer (varies with populations and geography—the Bay Area in California is now thought to be 1:8!) The risk of ALCL may be 1:3000 or closer to the other end of the estimate at 1:30,000. And that is only for the Biocell surface on all Allergan products prior to the recall, including silicone, saline, or even tissue expanders for reconstruction. Sientra, another major manufacturer here in the US is reporting perhaps 1:175,000 and that number may be conflated due to a prior Biocell surface device. Mentor’s Siltex surface does not provide good numbers in my opinion but appears to closer to Sientras experience that Allergans.Talk with a few doctors before making this critical decision. Merely removing the implant does not eliminate the risk of ALCL. The entire scar capsule must be excised. This is traumatic and potentially dangerous. There are plastic surgeons, I am ashamed to say, who are trying to capitalize on women’s fears and promising “en bloc” capsulectomy (not trace left behind theoretically and totally unproven!) The vast majority of plastic surgeons are listening to the smartest men and women out there in plastic surgery and medicine in general—”if it ain’t broke, don’t fix it”.For more information search for the ALCL guidelines from the American Society of Plastic Surgeons. For information on breast implant related illnesses, I would have you read the article “Breast Implant Associated illness—myth v. science” It is written by one of the smartest plastic surgeons alive, Dr Rod Rohrich who is also the editor of the esteemed journal “Plastic & Reconstructive Surgery” . As the editor and as former head of the Department of Plastic Surgery at Texas Southwestern, Dr Rohrich has access to tons of data. And data is what we are still seeking in this difficult subject.Thank you for reading. Dr Berkowitz

Your question, when including the additional questions in your comment, is difficult to answer.The cost and best location to get it done will depend totally on what country you live in, and your reason for getting the implants.The latest techniques depend on what type of implant installation you are getting. Implants are used for both enhancement and post-mastectomy reconstruction.I would personally be wary of anyone wanting to use a "new technique" on you. If you are getting your body altered for any reason, you want as small a chance of complications as possible. Latest and greatest, and 'cutting edge' techniques, mean that the surgeon has little experience doing them (or they wouldn't be new). Personally, I if I had to have anything other than the standard, I would go for advanced but proven techniques that a surgeon knows extremely well, over something new and hyped. You want as un-complicated as possible.As for the rest, my experience is with reconstruction, but some of these things are applicable to any implant insertion.It is very likely that it will not just be one surgery. Your body can do weird things when unexpectedly enlarged in one area? Little "wings" are common, on your sides. These are fatty flaps of skin and tissue that occur due to how the skin needs to stretch to accomodate the implant. You can look up the revision statistics for the type of surgery you are having. (Any surgery after the initial one is generally called a revision).Capsular contracture is always a risk. This is when your body builds scar tissue around the implant, and squeezes it, making it hard and misshapen.[1] (the referenced article is about enhancement, but this is a potential problem for anyone with breast implants)If you need tissue expanders to make room for the implant, make sure you find out the details on them. Some are not safe in MRI's and some can set off security detectors at airports etc.Implants do need to be changed at some point - your surgeon will tell you the lifespan of yours.You need to communicate with your surgeon. You will be a team, so be open and honest about what you want, and listen to them when they tell you what will happen. Always follow their instructions exactly, and whatever you do, don't lift anything too soon.WarningIf you have any hypersensitivity issues, multiple allergies, fibromyalgia, and/or autoimmune diseases / conditions, I would seriously consider whether this was worth the risk or not. For normal, healthy people, implants these days are generally very safe and well tolerated. But for people with whacky immune systems (not weak - I mean whacky), there is a possibility that your body will not tolerate the implants.This can happen right away, or after having them for years. This type of rejection can cause capsule formation, a lot of swelling, systemic inflammation, increased allergies, fatigue, joint and muscle pain, coughs, fevers, sweats, hot flashes, weird rashes anywhere on your body, IBS problems, and a bunch of other autoimmune-type symptoms.Problem is, if you have had augmentation, your skin is now shaped to the implants, so you will need a skilled surgeon to put things back to your smaller size. Then you may need more revisions until you're satisfied with your new non-implant self.ORIf it is a reconstruction situation and this happens, they will give you the option to make the breasts from your own tissue - usually belly fat (called a DIEP flap reconstruction). This is what happened to me, so I am scheduled for a DIEP next month.Footnotes[1] Symptoms, Treatment & Prevention

This was a very important hearing. My partner was able to be one of the surgeons who spoke on behalf of her breast reconstruction patients. The hearing was in response to two separate issues—BIAI or breast implant associated illness, and BI-ALCL or breast implant associated anapestic large cell lymphoma. Let me break this down with a forty year historical perspective.BIAI. Silicone breast implants had been in general use without sufficient studies submitted to the FDA for 30 years prior to a 1992 ban on all silicone gel implants. This ban was a result of patient complaints of a number of illnesses such as rheumatoid arthritis, scleroderma, chronic fatigue syndrome and thyroid disorders among others. It was all lumped together as Human Adjuvant Disease. Fifteen years elapsed before the ban was lifted. During that time span silicone implants had become the most studied device in the history of the FDA. The few manufacturers who survived at that time submitted the required data to show their safety profile. When silicone returned to the US market in 2006 the FDA had reached two basic conclusions. The first was that breast implants were not associated with collagen vascular diseases, such as rheumatoid arthritis, and scleroderma or chronic fatigue syndrome. This was based on studies from the NIH and several prominent universities. No one denied that yes, women are more subject to these auto-immune diseases and yes, women get breast implants. In other words “true, true and unrelated”. This answer did not sit well with many women who were certain of the cause and effect relationship. The internet gave them a voice. Their voices were heard by Dr Mark Clemens from MD Anderson hospital in paper in Plastic and Reconstructive Surgery last year. With the internet also came much deeper data bases and the ability to construct meta analyses that supported these claims—possibly. His conclusion, as was the conclusion of the FDA, was that these claims will require more scrutiny in the form of more rigorous tracking and reporting to the FDA. Plastic surgeons have been admonished not to dismiss these claims by our patients by our parent societies American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery. Implant registries have been established by our societies. We look forward to identifying the relationship if one does truly exist.BI-ALCL. The FDA was responding to the mounting evidence associating certain textured devices with this rare high grade lymphoma as a result of chronic inflammation. The origin of this disease is not well understood.Chronic inflammation is known to be associated with lymphomas. This is known as the oppenheimer effect. Patients with chronic inflammation due to Hepatitis C are known to have a higher incidence of B cell lymphoma. You must treat both simultaneously to successfully eradicate the lymphoma. There have been reported cases of both dental and joint implants that have caused ALCL. There is also some evidence that it may be related to implant surface contamination in surgery due to a gram negative organism Ralstonia Picketsii. This is not a common bug. It would need to be introduced in the insertion and handling of the devices during surgery. Of interest is that the incidence of this disease seems to be more prevalent in Australia and no cases from Asia or Scandinavia where textured devices have been the norm since their introduction almost three decades ago. And all texturing does not carry the same incidence. Polyurethane foam covers, the original form of texturing carries the highest risk wherever they are used. They were eliminated from the market here in 1992 due to evidence of breakdown products could be carcinogens. However these implants were still in widespread use in France where they have banned all textured products. This may have been somewhat of a knee jerk reaction on the part of the French government because of the terrible outcomes from non-medical grade silicone used in PIP implants there a few years ago. It was a shameful incident for the industry and the French government. Mc Ghan Medical textured implants were introduced into Europe in 1993 through their plant in Ireland. The company is now Allergan. They were widely distributed and very popular in Europe throughout the 90’s and into the millennium. These have had a varying number of reports of ALCL depending upon the country where used but is thought to be about 1 in 30,000 in the US but may be as high as 1 in 4000 in Australia. Again, no Scandinavian or Asian cases to my knowledge. One possibility that has been raised is due to the irrigation used in the implant pocket. While Betadine was popular in the 80’s, it was banned here in the US in the instructions for use in the mid nineties based on some somewhat questionable research. So in the US we have used a triple antibiotic solution. Ralstonia is not sensitive to any of the three commonly used antibiotics in this solution and may actually encourage its growth by suppressing other bacteria. Where Betadine was not banned the incidence of ALCL has been less. The FDA recently lifted that ban here and we are all happily using betadine once again in the US. Other manufacturers than Allergan have all had a considerably lower incidence of ALCL—Sientra and Mentor in this country.So why use textured implants at all given this rare but serious problem? Smooth implants can only be round; they cannot be tear drop. That is an aesthetic concern. More importantly, textured implants are form stable and do not move, shift, bottom out or encapsulate as readily as the smooth ones. For breast reconstruction patients especially, texturing of tissue expanders and the implants have improved outcomes significantly. To do away with textured devices, in my opinion and of many key opinion leaders in our field such as Mary McGrath, Professor of Plastic Surgery and Department Head at UCSF who spoke at the hearings, it would be a giant step backward.Most plastic surgeons in the US use smooth round implants. This has as much to do as the ban on silicone in the nineties that required all surgeons to use saline devices that functioned much better as a smooth implant than it does with the incidence of ALCL. Surgeons who trained with smooth saline migrated to smooth silicone in 2007 logically.But let us consider, as did the FDA, that re-operation carries greater risk than the small risk of ALCL. The FDA has recommended against removing textured implants as a preventative measure for this reason. Likewise, I weigh the risk of malposition, stretch deformities and capsular contracture—all of which are of higher incidence with smooth implants—against the small risk of ALCL.ALCL is not a silent disease. It usually presents as seroma, or fluid collection that swells the breast and alerts the surgeon that this fluid must be tapped and sent to pathologist for cytological testing. Seromas are not uncommon around any breast implant and so not all seromas are due to ALCL. if treated expediently with total capsule removal and the implant, that is considered therapeutic. If the symptoms are ignored then there are cases that require chemotherapy and there have been a few fatalities.“ A few fatalities?” I can hear the gasp. All surgery , all medications, all activities of daily living carry risk and the risk of dying from a breast implant is dwarfed by the risk of death from almost any other surgical procedure. It is important to keep this all in perspective.Bottom line—if any woman in my family had textured breast implants ( and one , in fact, does) I would not recommend removal. If another member of my family wished breasts augmentation, I would consider textured implants from a manufacturer with a lower incidence such as Sientra or Mentor.