JPRAS, FDA and Cohesive Gel Implants

On the JPRAS, and It Said That Cohesive Gel Implants Should Be Investigated Thoroughly.Was This Abstract Considered by the FDA? The above link shows a summary but I can not read the whole article. Response to what this article has shown would be greatly appreciated. Was this looked at by the FDA?

Doctor Answers 4

Safety of silicone gel implants

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Hello Cleveland,

I work with Anindya Lahiri, who wrote this article.  It is a case report describing a patient with a rupture of a silicone implant and associated lymphandenopathy.  This is something to be aware of and useful to know that it can occur. 

The main concerns regarding the safety of silicone implants revolved around their association with connective tissue disorders such as rheumatiod arthritis and there has been shown to be no link with this.

You can use the information in this article to help you decide whether silicone implants are right for you, but it does not suggest that the implants are not safe and I do not think that the FDA would consider this information significant.

Safety of Silicone Gel Breast Implants

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The FDA did not have access to this article when they re-released silicone breast implants again due to the dates of the publication and release of the implants. However, the FDA is continually monitoring the implants and believes they remain safe. The reported one case does nothing to change that perception. The fact that silicone was found in the lymph nodes simply means that the patient’s lymphatic system was doing what it was supposed to do, mainly clear the tissues of any foreign material. Although I, too, did not have full access, the patient appears to have had no other problem. Since this is the only report of this exact problem, it is extremely rare. The incidence of problems still remain as low as or lower than most other implantable devices.

Robert T. Buchanan, MD
Highlands Plastic Surgeon

Safety of silicone gel implants. JPRAS article.

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This case report from the plastic surgical literature of Great Britain describes a single patient with a unilateral silicone prosthesis rupture, and is certainly something to be aware of when looking at overall claims of silicone gel implant safety. The article, reported in the August 2006 Journal of Plastic, Reconstructive, and Aesthetic Surgery (Vol 59 Issue 8 Pages 885-886) was submitted for publication in 2005, and reported a case of intracapsular implant rupture with 8 enlarged axillary lymph nodes showing microscopic silicone granulomatosis in a woman who received her implants 6 years previously, and noted "a breast lump and multiple axillary lymph nodes." This means her implants were placed around 1998 or 1999, and may have been on her surgeon's shelf for some time before that. This also means they were likely NOT the latest generation of (more) cohesive silicone gel implants. There have been other similar case reports prior to and after this one--this is hardly a "smoking gun" for you conspiracy theorists!

Although this patient's implants were described as "cohesive," the present generation of more highly crosslinked implants is an entirely different kind of implant from those most likely used in this individual case. Older implants were still described as "cohesive" because they were in fact "more" cohesive than earlier generations of silicone breast implants that utilized a much less viscous and even oily silicone "filler." These implants could indeed rupture, leak, and have microscopic molecules of silicone present in the capsule around implants, and in cases of major implant shell damage, also present in adjacent armpit lymph nodes. Though capsular contracture and enlarged lymph nodes could be seen in these cases, there still remains no credible scientific data that shows silicone implants as a cause-and-effect factor in any type of autoimmune or "human adjuvant" illnesses.

Realize that cohesiveness is a spectrum of crosslinked polydimethylsiloxane molecules that range from silicone oils useful as lubricants to highly crosslinked silicone rubbers used in implants, catheters, pacemaker insulation, and in industry as (non-medically pure but similar) bathtub sealants or gaskets! (BTW, the "gummy-bear" implant is an even more cohesive silicone implant presently under FDA study and review--still not available or approved for general use--compared to the Memory Gel or Natrelle implants, part of that same "cohesive" spectrum!) The present generation of cohesive silicone gel implants are like two pieces of Jell-O when cut in half--they do not leak or ooze, and maintain their shape and intactness in the event of shell damage. That is one reason they are safer than the older implants, and one reason the FDA released them for use in the public where before restrictions existed.

Many such reports were evaluated by the FDA in their exhaustive reviews prior to the re-release of silicone gel breast implants for primary elective breast augmentation in November of 2006. Frankly, this article reports nothing new (then or now) and was in fact a bit late to the medical literature compared to similar reports. As long as your plastic surgeon is using the newest generation of cohesive silicone gel breast implants (Memory Gel from Mentor, and Natrelle from Allergan) this kind of rupture is no longer an issue, and FDA recommendations to have periodic MRI scans to "look for" occult or "hidden" rupture is nonsensical. For older silicone implants, I still prefer surgical recommendation based on correction of a problem (contracture, malposition, or request for different size) rather than "operating on the basis of a scan report." These scans (FDA data) are INCORRECT over 21% of the time, meaning they show "rupture" when none is identified at surgery!

Richard H. Tholen, MD, FACS
Minneapolis Plastic Surgeon
4.9 out of 5 stars 263 reviews

Breast Augmentation, Breast Enlargement, Breast Implants

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The silicone gel implants were investigated for over 14 years by the FDA.  The implants were cleared and work well for most women. 

Jay H. Ross, MD, FACS
Palm Harbor Plastic Surgeon

These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.