Tuesday, April 18, 2006

Surgeon charged in implant study violation

A fairly prominent LA plastic surgeon has been charged with doing an end-run around the current FDA restrictions on silicone breast implants by fudging enrollment criteria in the adjunct studies and importing French-made implants via Mexico. This is disappointing but not surprising. It highlights two important things.

1. It's not worth cutting corners

2. The lunacy of the current FDA restrictions

The "compromise" imposed in the early 1990's by then FDA Commissioner, David Kessler, reserved implants for cancer patients and complex cosmetic cases. These were exactly the WRONG patients to choose if you were worried about device safety and post-operative complication rates as their expected reoperation rates are signifigantly higher then primary breast augmentation patients.

The FDA is still currently sitting on the 2005 advisory panel endorsements for Inamed & Mentor.

6 comments:

Anonymous said...

You call the FDA restrictions "lunacy".

And WHO has an "agenda"?

Wow.

Anonymous said...

You have decided silicone implants are perfectly safe. Other renowned plastic surgeons and scientists have not come to that same conclusion. You write them off as being biased, but you are the one who is unbelievably biased. You do a disservice to your patients and to anyone who reads this blog.

Anonymous said...

This does not highlight the 'lunacy' of the FDA restrictions, although I agree that women with cancer are the very last women that should have silicone implants.

What this highlights is the problem with plastic surgeons bypassing the adjunct study. The FDA is aware of the notorious lack of compliance in the adjunct studies. I would say half of the women I talk to were never given any information about the "study" in which they supposedly were a part. Many were not given any information about their implants! And, of course, many were not told of possible complications, including systemic illness.

But then I imagine you don't do that either, since you so arduously color your argument to show the 'lunacy' of FDA concerns about breast implants.

Also, the FDA panel never recommended approval of Inamed. The FDA chose to send a letter to Inamed saying it would consider approval if they met certain conditions. That is very different.
That you continue to misrepresent what actually happened at the FDA hearings is very telling.

I hope that people who read this "blog" also recognize the bias it represents, and the financial interest you obviously have...or, maybe it is pure zealotry. A serious character flaw for a surgeon.

Dr. Rob Oliver said...

I've decided to leave the troll comments on this thread and address some of her concerns:

- Lunacy was letting the plaintiff lawyers & activists run roughshod over the data when this issue was considered & leaving an illogical compromise in place.

- There is no groundswell of Physicians or Scientists still claiming widespread links to connective tissue disease

- The issue of playing loose with adjunct study criteria is something I would agree is wrong. These are the rules we have to live with, and people abusing this cause problems for other Plastic Surgeons & the manufacturers. However, the rules themselves are poor & we hopefully will be ending the current state later this year

-In re. to Inamed, they were given the chance to resubmit their data to the Advisory Panel Members to address specific concerns and withdraw the double lumen style 153 implant. They subsequently recieved an approvable letter after review by the same panel members without a second vote. Thus, they did in fact get a defacto approval by the committee.

- There is a standard informed consent that the patient has to go thru & initial in multiple areas. While, I assume some patients are less diligent, the information is there & they have to sign it to get their implants released. If not the surgeons are likely to be removed from the adjunct study for repeat violations. The manufacturers take this very seriously.

Anonymous said...

No, Rob, it is not that "patients" are less diligent.
DOCTORS don't provide patients with the information. This happens all the time.

There are many doctors who disagree with your assessment of the safety of silicone implants.
You have an agenda, and that is clear.
I have zero respect for you, but you probably already know that.

Dr. Rob Oliver said...

Molly,

- If you know Surgeons you believe are not following the Adjunct Study rules re. consent, let the FDA & manufacturer study coordinators know. They take it seriously & have been willing to remove people from participation. What the FDA requires is availability of a copy of the Institute of Medicine report, which as you know found a lack of evidence to substantiate claims of systemic illness.

There is a very detailed informed consent (reviewed & approved by the FDA) with silicone implants that MUST be signed by patients. It's hard to complain that information is not presented to patients.


- There are indeed some Doctors who are still convinced there are troubling risks with the devices. However, after 15 years of studies & reviews almost uniformly negative on the most serious alleged problems, most people are convinced that problems are largely local rather then systemic