Plastic Surgeon Sends the Wrong Message
Dr. James Romanelli, a plastic surgeon from Huntington, NY, is featured on two YouTube videos (see “Durability of Saline & Silicone Breast Implants” below) demonstrating and discussing breast implants and giving “the facts” on the pros and cons. Really.
Despite Romanelli’s reassuring voice and the fancy lab coat and tie, we decided to double-check those facts and see if he knew what he was talking about. We asked Dr. Edward Melmed, a plastic surgeon who has testified frequently at FDA hearings and now performs explantations, to weigh in on Romanelli’s statistics. The results are in; maybe we shouldn’t let the lab coat hide the truth.
Dr. Romanelli: For saline implants, the incidence or rupture/leakage is 2% over 7 years, 3% over 10 years.
Dr. Melmed: Yes, saline does last about 10-12 years. But in almost all implants the problems BEGIN after 10 years. Look at the latest edition of the Annals of Plastic Surgery. There is a LONG TERM report on implants from Sweden (Dr Holmlich). The figures are: a 62% capsuler contracture rate, a 39% re-operation rate, and a 21% rate of lymph nodes, even with “intact implants” [not ruptured]. How does Dr Romanelli account for this? Maybe these are only “minor inconveniences.”
The FDA’s statistics are considerably higher regarding rupture. According to the FDA Breast Implant Consumer Handbook from 2004, “[p]rospective studies of saline-filled breast implants approved by FDA in May 2000 showed rupture/deflation rates of 3-5% at 3 years and 7-10% at 5 years for augmentation patients. The same studies showed rupture/deflation rates of 6-9% at 3 years and 8-18% at 5 years for reconstruction patients.” For silicone implants, 344 women who had augmentation surgery before 1988 were found to have a 69% rate of rupture in at least one breast implant. A study from the Annals of Plastic Surgery concluded that, out of nearly 10,000 removed implants, “26% of implants were ruptured by 3.9 years, 47% were ruptured by 10.3 years, and 69% were ruptured by 17.8 years.” Not so reassuring after all.
Dr. Romanelli: If there is a leak [in a saline implant], saline leaks into the body and is harmlessly eliminated.
Saline solution, like the one they use in I.V. drips and what you might drop your contact lenses into at night, has an expiration date. How do you know when your implants really expire?
Dr. Romanelli: If the silicone gel implant is cut, the gel doesn’t leak out.
Even if silicone gel is not released from an implant, silicone oils are released. That is from Dow Corning’s scientific documents.
Dr. Romanelli: If there is a pinhole leak [in a liquid silicone implant], it may cause a change in shape, hardness and scar tissue.
Dr. Melmed: Silicone does NOT cause capsular contracture by leaking. The mere presence of a foreign body (in this case a very large one) causes capsules and they contract. You get the same with sutures, shrapnel, glass, and any foreign body. Just think of a splinter—it gets hard and tender, and when removed the FB reaction stops and everything gets soft.
In a study conducted about 30 years ago and published in the Annals, over 60% of the women examined had experienced “clinically significant” capsular contracture.
Dr. Romanelli: The material inside the silicone gel or “gummy bear” implant stays connected to itself within the shell… 80% of patients choose it over saline implants. “I do believe it’s a safe implant.”
Dr. Melmed: The good Doctor Romanelli says: gummy bears are SAFE. On what basis does he come to this “scientific” conclusion? Has he used them long term? I have not seen any reports by him. Is it based on the long term (over 10 years) reporting and testing by the manufacturers? I have not seen these either.
The gummy bear has a higher level of platinum in it to make it “cohesive.” Platinum can cause a chronic debilitating lung disease - see cases of people who worked in carburetor factories where platinum levels are high. (By the by, the FDA doesn’t seem too sure about platinum either… check out the FDA backgrounder on platinum in silicone breast implants that leaves a lot to “still be determined.” Yet another instance where the research just hasn’t been done.)
Dr. Melmed puts it perfectly: “There are two stunning aspects to Breast Implants: (1) women put up with unbelievable pain, and suffering to live with breasts enlarged with bags of gel or water, presumably so that other women can be jealous and men can ogle, [and] (2) plastic surgeons are blind to any and all complications (if it were any other operation with these problems it would have been abandoned or outlawed years ago).
Dr. Romanelli sounds so calm and reassuring, but it’s not about what he’s saying—it’s about what he’s NOT saying! As we know, too many women aren’t given and don’t seek out all the information about what they do to their own bodies. Which is exactly why we’re here.
TAGS: 
breast implants 
cosmetic surgery
WHAT A WONDERFUL INFORMATIVE ARTICLE!! It is so good to know that we have at least one unbiased medical expert that is willing to stand up and tell the REAL INFORMED TRUTHS about breast implants. THANK YOU DR.MELMED!
Women considering breast implants need to wake up and realize that the plastic surgeon is the same as a car
salesman…if you walk out the office door with out buying the implant surgery… he has lost $$$$. MANY ( not all )
plastic surgeons will down play the faults just to get the sale! BUYER BEWARE!
Comment by Pam Noonan-Saraceni — February 26, 2008 @ 10:17 am
Wow! Dr. Melmed’s comments were very basic, yet so very powerful.
“Dr. Melmed puts it perfectly: “There are two stunning aspects to Breast Implants: (1) women put up with unbelievable pain, and suffering to live with breasts enlarged with bags of gel or water, presumably so that other women can be jealous and men can ogle, [and] (2) plastic surgeons are blind to any and all complications (if it were any other operation with these problems it would have been abandoned or outlawed years ago).”
Simply amazing. I only wish that all women considering getting implants would read these comments before making a final decision. Sometimes I can’t believe what women will put up with in order to make other women jealous and make men ogle over them. Second, it IS truly amazing that this operation hasn’t been outlawed considering all of the complications and sickness that it causes. I guess we can only hope that one day it will be….
~Krista
Comment by Krista — February 29, 2008 @ 9:49 am
Hi, ladies:
I think Dr. Melmed is being too kind–I don’t think implants are even THAT reliable. Take a look at the safety data on Allergan (nee Inamed, nee McGhan) and Mentor’s own sites! They, themselves, report re-operation rates of up to about 40-50% IN 3 YEARS! They report very high deflation rates of salines, and very high CC rates for silicones. They also report a miscarriage rate of about 1.5%, if I remember correctly (though I don’t know the miscarriage rate for the general population)
Mentor’s own safety data also acknowledges a probable link between breast implants and autoimmune diseases, and I imagine that Allergan’s does, too (I haven’t really “dug into” Allergan’s).
The safety data also advises the implanting surgeon to require that the potential “implantee” be given at least a week to study the safety data. Since I’ve heard of women saying that they were given their “Informed Consent” forms to sign while they were laying on the operating table, already prepped for surgery, I doubt that many plastic surgeons even FOLLOW the manufacturer’s recommendations.
I bring this up because if the manufacturers print it on their own websites, they can’t really deny it, can they?
Please visit my website, http://www.implantingtruth.org, and read my story (the only one there right now, but I’m working on getting more). My story provides links to Mentor and Allergan’s safety data, and a way of “putting it in perspective.” You may also read it on Jeena’s site, http://www.explantation.com, and on Ilena Rosenthal’s site, http://www.breastimplantareness.org.
Comment by Jeff Sellick — March 25, 2008 @ 10:17 am
Dr Romanelli Responds:
Wow, what a shock to produce an informational video on the differences between contemporary and old style breast implants and to be slammed for wearing a lab coat and a tie. And that is just the personal-attack aspect of this mocking blog.
Let’s get to the data: in the video I accurately quote the rupture/leakage rate of smooth round modern breast implants at 2% over 7 years, and 3% over 10 years. Dr. Melmed counters with old data about older style and textured implants. His data is accurate, but not relevant to patients contemplating the use of breast implants today.
Capsular contracture (not discussed in the video) is quoted by Melmed at 62% in one study. Many surgeons who are active in the use breast implants for reconstruction as well as augmentation, have adopted two critical techniques to dramatically reduce the incidence of capsular contracture: 1) extremely careful attention to avoid bleeding around implants (so much so that for many of us, patients rarely have bruising), and 2) washing the implant pocket with a solution containing 3 different antibiotics. The latter technique produced a 14 month grade III/IV capsular contracture rate of 1.8% in patients undergoing primary breast augmentation and 9.5% in patients undergoing breast reconstruction. (Adams, W. P., Rios, J. L., and Smith, S. J. Enhancing patient outcomes in aesthetic and reconstructive breast surgery using triple antibiotic irrigation: Six-year prospective clinical study. Plast. Reconstr. Surg. 117: 30, 2006.)
Breast Implant Safety: My description of breast implants as “safe” is derided as if it were an opinion I formed independent of science. Actually, the FDA has found both saline and silicone breast implants “safe” and “effective.” That is why they are available today.
In 1992 the FDA took liquid silicone filled implants off the market because of safety concerns: specifically, some women believed their ruptured silicone implants caused medical illnesses such as auto-immune and rheumatologic disorders. In 1999 the Institute of Medicine found no link between ruptured implants and medical illnesses. There are, of course, potential local complications that patients need to be aware of.
Melmed would be well advised to read “Science on Trial: The Clash of Medical Evidence and The Law InThe Breast Implant Case,” by Marcia Angell, MD, 1996. Dr. Angell is a board certified pathologist and former Editor in Chief of The New England Journal of Medicine. Her book debunks the junk science that surrounded the breast implant scare of the late 80’s and early 90’s. It also references the predatory neurologists, rheumatologists and surgeons who made a living off of the non-scientific belief that ruptured gel implants caused medical illness such as connective tissue disorders. The anxiety and fear they created in women who had gel implants was inexcusable.
Search google and you will find that Melmed was one of the believers of these unsubstantiated concerns. Having been found wrong on the science by both the Institute of Medicine and the FDA, Melmed now raises new unscientific arguments. Melmed raises the peculiar argument that the saline within breast implants expires. And he also raises scientifically unsubstantiated concerns about platinum used in the manufacture of implants. So are we to believe that the FDA and its peer organizations in Canada and the European Union are all wrong, but Melmed is right?
Outlaw Breast Implant Surgery?
At least one blogger suggested implant surgery should be outlawed. Is that a serious suggestion? Should women not have a right to choose a convenient means of breast reconstruction? Or to enhance breasts that they feel are not proportional to the rest of their body? Breast implants do have complications, and some women have bad outcomes. Every woman considering breast implants, whether for reconstruction or augmentation, deserves to be well-informed. Patients in my practice routinely have two hour-long consultations prior to breast implant surgery, and my informed consent form exceeds 5 pages. Every woman is told implants are not guaranteed as lifetime devices, and may require re-operation
Severe Pain?
Melmed states that “women put up with unbelievable pain, and suffering to live with breasts enlarged with bags of gel or water.” If the pain is unbelievable, then the surgeon is unskilled. I don’t know what he is referencing, but patients typically find the pain mild to moderate, and are back to work in a few days after breast augmentation. Breast reconstruction patients who have implants placed at the time of mastectomy generally spend 1-2 nights in the hospital, the same as for mastectomy alone.
The Bottom Line
Choosing to use breast implants for breast reconstruction or breast augmentation is a decision women should weigh seriously. It is important that the information presented to women be balanced and based on science. Dr. Melmed’s comments lack scientific credibility.
Comment by James Romanelli, MD, FACS — April 8, 2008 @ 7:54 am