Truth on ‘Cohesive’ Gel Implant

Pierre Blais J. J. B. Blais, B. Sc., Ph.D., C. Chem., F.C.I.C. was the former Senior Scientific Advisor for Canada’s now-defunct Department of Health and Welfare for fourteen years. He now runs Innoval Consultants, a firm engaged in the design, testing, and failure analysis of high risk medical systems. In his line of work he has examined over 7,000 cases of explantation, from which they have recovered over 9,000 different implants. Blais says they’ve seen “every single type that has ever been used worldwide. Some are as old as the 1950’s.”

The terms “cohesive gel” and “gummy bear” were introduced in breast implant promotion circa 2005 and have now become ubiquitous. Citing testimonials from conspicuous plastic surgeons, internet websites describe the “cohesive-gel” breast implant as a recent innovation of great merit. Such implants are presented as longer-lasting, providing a more attractive shape, safer, and having undergone rigorous testing.

“Cohesive gel” is an old term but in the context of breast implants it is an oxymoron. The technology employed to fabricate gel-filled breast implants requires that the gel be transformed from an invasive liquid to a stable semi-solid. This is achieved by mixing reactive liquid chemicals in various proportions and
“baking” the mixture until it congeals into a mass. The technology to achieve cohesivity is described in patents of the late fifties and early sixties and remains essentially unchanged. Cohesive-gel implants commercialized nearly half a century ago fell into disuse because plastic surgeons did not like their inability to deform during surgery, preferring pliable implants that could be stretched and “stuffed” through a small incision. The early cohesive-gel implants were abandoned in favour of soft, stretchy, thin-shelled products that dominated the market until 1992 when the U.S. Food and Drug Administration (FDA) imposed a Moratorium to restrict use of silicone-gel-filled implants. Thus, to present the “cohesive-gel” breast implants as an innovation of recent origin is incorrect.

Claims that the currently promoted “cohesive-gel” implants are longer-lasting and safer are not demonstrated. Implant durability is unrelated to cohesivity of the filling gel. Instead, durability is determined by how the user’s tissue reacts to the foreign object and its effluents. The tenacity, chemical resistance, and ability o f the shell to resist stresses created by user movement are the key factors that determine how long an implant shell can hold its filling gel. Implants of any type, cohesive gel or not, drastically change the environment where they are implanted. Viable tissue is converted to hard frangible material intermingled with calcific deposits, a necrotic process which ultimately causes the implant to be surrounded by dead and abrasive material which erodes the shell. Compression by the surrounding tissue capsule deforms the implant and causes the shell to crease, leading to fracture. Calcific deposits create an alkaline environment which chemically attack the silicone shell causing it to fragment to inflammatory debris. The same environment converts the gel to an invasive liquid. These processes accelerate as the implant ages. Therefore, there is no basis to claim that a “cohesive-gel” implant is longer-lasting or safer.
More than 700 types of implants of assorted shapes and sizes have been commercialized since the sixties. All have been marketed on the belief that the breast would imitate the shape of the implant. Experience reveals otherwise. Within several months following implantation, contractile tissue forms around the implant. This process, combined with the anatomic constraints imposed by the user’s chest, deform the implant to an irregular spherical shape, creating the classic augmented breast profile. Nothing short of a hard, nearly rigid implant could retain its original shape after several years of sustained contracture. The claim that the “cohesive- gel” implant imparts a more attractive breast shape is at best wishful thinking.
Pre-clinical and clinical testing of breast implants has never been a serious undertaking. The architects of the FDA’s 1992 Moratorium attempted to change this long-established practice. Breast implant manufacturers were compelled to conduct controlled studies on breast implant safety, upgrade quality assurance practices, and maintain patient follow-up. In response, the three surviving breast-implant manufacturers agreed to the set conditions hoping that the FDA would approve the open sale of their products. Findings from the studies were at best mediocre. Nevertheless, and largely because of pressure from special interest groups, the FDA conceded to the manufacturers’ demand in 2006 and silicone-gel-filled breast implants were declared “approvable” for breast augmentation.
The FDA’s approval had little to do with “rigorous testing”. By 2010, flaws had become obvious in the promoters’ sponsored studies. Adverse events culminating in implant removal and individuals lost to follow-up were the most noteworthy findings, the same observations which characterized earlier testing of breast implants. Retrospectively, the tests were neither rigorous nor specifically applicable to the currently-promoted “cohesive-gel” implants and claims of superior performance and safety remain debatable.

Through repetitive promotion, the belief has spread that breast implants marketed post-FDA Moratorium are “new and improved”. This belief is illusory. Currently promoted breast implants are basically the same products which were widely sold during the early seventies. They embody minimal design changes and employ substantially identical ingredients. Manufacturing processes are similar albeit more mechanized, reflecting a desire to reduce production costs.

In summary, the events of the last four decades give credence to views widely held by many in the biomedical field that the currently promoted breast implants are nothing more than reissues of products commercialized more than four decades ago.

Innoval Failure Analysis
Ottawa, Canada K2A 2V1
August 2011

59 Responses to Truth on ‘Cohesive’ Gel Implant

  1. Rosa Garcia says:

    Melissa, i have all, i mean all, the symptoms you have. At first i thought that implanst could be the problem, but, i had most of these symptos before i got the implans in 2007. I have two sisters and they are sick as me. I just did a genetic test and discover i have several genetic mutations, including hetero MTFHR 677, now i am taking some supplements that make me feel good, now i have more good days than bad, i am still eating organic, etc but some days i feel awesome ! I dont know what i am goind to do with the implanst because they look and feels so good ?

  2. Cassie says:

    I am honestly surprised to see so many people having these serious health issues with cohesive gels. I got mine nine years ago in Germany. I have at least seven friends who had them done there by the same doctor. We were all Army wives. None of us have had any problems. Most of the women that had them got them done a year or two before I did. We have all been satisfied with the results and have had no health concerns. This does scare me a bit, but I am hoping that since there have been no issues so far, that we are all OK.

  3. Brenda Mason says:

    Cassie I hope you will be ok. But, it’s really not a matter of if it is a matter of when you start getting these symptoms. I am not trying to scare you at all. Just make sure you really pay attention to any changes you are experience. For me, it was pretty quickly. One day I woke up with one symptom and then another and another.

  4. Brandy says:

    Thank god for your website. I’ve been considering the cohesive gel implants for awhile and was under the impression (from doctors of course) that they were safe. There’s no way I’d get them after reading this. Thank you thank you!!

  5. minerva sy says:

    It was already 20 yrs ago having my gel silicone implants and its okey for my health and the formation of my bust is still the same maybe lifetime as my doctor told

  6. Stephanie Maxheimer says:

    I live in Savannah Georgia (USA) . I worked for a plastic surgeon for ten years, had multiple surgeries and none of them came out great. My concern is about my implants I had placed in 2007 , “gummy bears” from mentor. Since I was working there I paid nothing for them, but I also never heard the down side of these implants. I was fired in 2009 when I got pregnant with my only child and almost had a miscarriage (I was put on bed rest for 8 weeks and my greedy Doctor wasn’t going to have that). Point being I have had a child and breastfed her and my right implant is severely deformed to where you can feel the ridge from the encapsulated implant. This breast hurts also and is larger. I need to have them removed but I do not trust any of the doctors in my area to do this, I know all of their backgrounds and mishaps. I want someone who is truthful and can do a proper explanation and lift so I do not have to have anymore implants. I may go the route of reimplantation with saline to avoid the nasty scars of a lift. My question is who is the best surgeon for explanation?

  7. Adella says:

    Thank you for you email. We have many women that still suffer with Saline implants (they still contain silicone) and would be very worried for you if you got reimplanted. See this youtube video:
    https://www.youtube.com/watch?v=XwNE1uwKyIo
    As noted many times within this website, with any Explantation you must have it completed enbloc.
    Here are a few Dr’s in your area. Many blessings to you.

    ?Dr. Susan Kolb: P/S , Plastikos
    4370 Georgetown Square Tel: (770) 457-4677
    Atlanta, GA., 30338 http://www.plastikos.com
    e-mail: drkolb@plastikos.com

    ?Dr. Barbara L. Davies: M.D.
    Savannah Plastic Surgery
    7208 Hodgson Memorial Drive Tel: (912) 351-5050
    Savannah, GA., 31406 Fax: (912) 351-5051
    http://www.savannahplasticsurgery.com
    satellite offices: Brunswick
    2705 Wildwood Drive
    Brunswick, GA

  8. D says:

    To the poster named Melissa

    You sound like you have an exteeme vitamin b deficiency.

    Before you assume it has something to do with your implants, find a doctor who takes you seriously enough to do a full blood panel.

  9. David says:

    Thank you so kindly for not only putting this site up, but for maintaining it.

    After breastfeeding her children, and age, my wife of 42 has been asking to get implants because she is so unhappy with what has happened to them. I have been advocating that is the result of the wonderful gifts she has given us, but in the end it is her body and her choice…

    The best I can do is to use information to dissuade her from these devices in her body, and to love herself as she is; that we are all a road well traveled and carry the history of our lives in our bodies.

    I am grateful there are women who are willing to stand up every day and publicly claim and own their own history, so it may not become that of another.

    I will use everything on this site to try and turn her away from it. I really need the help, because I am a frugal man, which is what she thinks is behind my attempt to dissuade her. It’s true I don’t want to spend on implants and explants, and the incredible cost of ongoing health concerns, but it is far more true that I would like a healthy active lady in my life who never faces these issues to begin with.

    Thank you tremendously.

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