Friday, November 02, 2007

Patients in clinical trials - a footnote to the breast implant patients in the New York Times article

Today's entry is kind of an "inside baseball" thought that occured to me reading an article on medicine.

There was a breathless article on the news wire "Participants Left Uninformed in Some Halted Medical Trials" (syndicated from a New York Times story) earlier this week about the fate of patients who were enrolled in clinical trials for devices or drugs that had been discontinued. In many instances these patients (and occasionally their doctor) were apparently unaware of this fact. They used two medical devices as examples - vascular stents used to treat aortic aneurysms and a type of breast implant used in cancer reconstruction.

The stents are a potential big problem in that if they don't perform as designed, the patient will die. The breast implant patients (two women in south Florida) seem to be having much less an urgent issue. From the thumbnail description it sounds like the women were having some degree of capsule pain, which is not terribly uncommon especially in breast reconstruction patients who've been radiated. Capsular contracture is also the way some silicone implant ruptures present.

Implied in the NYT article is the implication that these women are "sitting on a time bomb" with their implants which is really silly and makes the juxtaposition from the stents scenario kind of ridiculous. In this instance, I'm not sure you'd do anything at all different for these women other then checking for rupture. No one would recomend "prophylactic" removal of those implants in the abscence of documented rupture, particularly if the implants were less then 10 years old. We have plenty of information about the treatment of silicone breast implant ruptures, and it's well established that the problems you get are local issues to the chest wall. A capsular contracture or ruptured implant is it's own issue, but to hold it up next to potential life-threatening device failures misses the real serious problems with medical devices and their surveillance.

They don't really go into much detail other then identifying the implant manufacturer, Allergan, and that the particular implant had been discontinued recently (~2005). If I had to guess, it's probably the Inamed "Style 153" implant these women had, which was an anatomically shaped silicone gel device that preceded the more advanced Style 410 "gummy bear" implants. Those implants, which were voluntarily pulled from the market by the manufacturer during their approval process negotiations with FDA for their conventional type of silicone gel breast implants.

The style 153 implant had an innovative "double lumen" core that had an apparent higher failure rate when you studied them on MRI scans (the best test for rupture). Confusing the issue is the resemblance of the double shell for some of the described signs of intracapsular implant rupture which is well described in this full text American Journal of Radiology article. There are a great many surgeons who strongly believe MRI's (or at least the radiologists reading them) have a tendency to over-estimate ruptures, particularly with this specific implant. At the end of the day Inamed made the decision in 2005 to "cut bait" on such a minor product to better their chances of FDA approval for their other products. The style 153 was a good implant for it's time, but it really was just a transitional model to the form-stable devices like the 410.

* Below is an MRI showing the characteristic "double lumen" sign confused for rupture occasionally with style 153 device



Anonymous said...

I'm considering (have been for more than 5 years now) breast implants and am curious as to what the post-op office visits would be like. We are planning on doing this while he is of work in Dec for 4 weeks so that he can take care of me if needed (he's a general surgeon at umich). We are planning on flying south for a couple of weeks after surgery to spend the holidays with the family but would it be possible if i had the surgery done? sorry to bother you with a question like this but i cant find the answer anywhere else. plus i dont have a doctor yet. starting our search in a couple of days.

Dr. Rob Oliver said...


Travel shouldn't be a big deal, particularly several weeks after surgery. If you have early complications (bleeding, wound break down, or infection - all of which are rare) you usually would have seen it well before then.

If you're worried about it, try to find out if there is a Plastic Surgeon in the area you're traveling to that is a friend or acquiantence of your surgeon. We all have patients that travel and understand that we have to help out colleagues if unexpected events happen outside of our care.

Thanks for dropping by! Come back any time.

Dr. Rob Oliver Jr.

Anonymous said...

Thank you, i appreciate the advice. Great blog by the way.

Anonymous said...

Hello Dr. Oliver,

I just came upon your article and wish I would have seen this earlier.

Let me tell you about the Two women from Tampa, One was a prophylatic surgery(brca2positive) and another had extensive cancer. One woman
brca positive had a mother who had (twice breast cancer) and grandmother (once) breast cancer and mother who died of ovarian cancer.
With that being said, "prophylatic" was the way to go. If the trial mice(the participants) are coerced,not informed,pressured,not given correct information about a trial study, then yes, "prophylatic" removing them is the safe way to go! Don't forget these women are "high risk" to begin with. Do you wonder why the 153 was taken off the market or(withdrawn)? Let's ask them,(allergan) because they are not talking or disclosing any of the rupture/complications associated with 153. Do you think it may be because they don't have it because the PI'S are not trained properly to take care of their patients?
Check out the maude report with the FDA and that may give you a clue of what is to come. I wonder if the silicone push is going to be another dow corning in the wings?

I can add that I have all kind of strange side effects that I never had before my silicone implants and that the saline is much more comfortable than that of the silicone for me. As for the other woman in the study she is having many, many serious complications from her implants and who knows what the out come will be for her?

I had my silicone implants (153) removed (possible intra-capsular rupture via-mri)and a few bubbles in the gel and some non penatrating nicks (so they say) but guess what? Tissue samples show non-polarized material on my slides. My guess is that silicone can travel outside the shell even if they appear to be intact.
The article was not comparing a life with an implant however, we did not die as of yet from silicone
implants but the emotional,physical,too many side effects to mention may have cost us our life in a different way.
I just believe that any physician has a responsibility to inform,take care and recommend the best outcome
for patients in risky situations.