Posts Tagged FDA
PIP implant makers did try to get FDA approval in the year 2000:
PIP was one of three companies that submitted an application, which came under review of a panel of outside advisors to the FDA in March 2000. At the time, PIP said it had already sold 35,000 of its pre-filled saline implants in the U.S., and that it was the third-largest manufacturer of breast implants in the world.
But the panel recommended that the FDA reject PIP’s application. Panelists said at the time they were not reassured by PIP’s data, and that the company’s clinical trials did not include enough patients that were followed for an adequate time to truly evaluate the device’s risks.
‘Like it or not, we have a regulatory threshold which is probably higher or at least different than it is elsewhere in the world, and I think in order to get your product approved, you’re just going to have to bite your tongue and meet that threshold.’
PIP saline implants had a high rupture rate as it became known in plastic surgery circles. The PIP saline implant line was available in the US for a short period of time ten or fifteen years ago.
Conservative surgeons like myself used very few of them and warned patients who requested them of their less than stellar reputation. I had one such patient who I remember had a rupture not-so-long after insisting upon having PIP saline filled implants.
She had felt PIP salines at another surgeon’s office and decided that these implants were for her. I actually had her sign a statement that I was recommending a US made implant with which I had more experience.
At least when saline implants rupture it is only saline (and a flat breast) with which the patient must be concerned. PIP silicone implants apparently had low grade silicone gel within them. This is a bit scarier.
I simply recommend any patient with PIP implants have them removed. It is a shame that not all women keep track of the implants they have had though.
John Di Saia MD
The U.S. Food and Drug Administration today announced that it has taken action against eight California surgical centers and the marketing firm 1-800-GET-THIN LLC, for misleading advertising of the Lap-Band, an FDA-approved device used for weight loss in obese adults. The FDA issued Warning Letters to Bakersfield Surgery Institute Inc.; Beverly Hills Surgery Center; Palmdale Ambulatory Center; Valley Surgical Center; Top Surgeons LLC; Valencia Ambulatory Center LLC; Cosmopolitan Plastic & Reconstructive Surgery; San Diego Ambulatory Center LLC; and to 1-800-GET-THIN because Lap-Band is a restricted medical device that is misbranded as a result of misleading advertising by these groups. In the letters, the FDA warns that billboards and advertising inserts used by recipients of the Warning Letters to promote the Lap-Band procedure fail to provide required risk information, including warnings, precautions, possible side effects and contraindications. The FDA also is concerned that the font size of information related to risks on the advertising inserts is too small to be read by consumers.
We have blogged on 1-800-Get-Thin and Lap-band surgery in general before.
Lap-band surgery like any surgery on the obese has not insignificant risks. The FDA apparently believes that these risks are not appropriately featured in the 1-800-Get-Thin advertising. It is interesting that the FDA has jurisdiction here due to the fact that the Lap-band is a registered medical device.
There was a time in which advertising for procedures was considered inappropriate in medicine. Advertising by its very nature is meant to encourage behavior in such a way as to benefit the advertiser. To expect advertisers to be forthcoming about negatives is probably expecting too much. Then again expecting the FDA not to investigate when there have been deaths associated with Lap-band surgery and 1-800-Get-Thin is probably also expecting too much.
This is amongst the reasons for my usual recommendation that potential surgical patients obtain physician referrals from less biased channels. In my opinion, patients should concentrate on choosing the right surgeon and evaluating him or her and their chosen procedure carefully before proceeding.
What do you really expect from an ad anyway?
John Di Saia MD
We have discussed the FDA’s recent consternation with the status of the post-approval silicone breast implant studies. In few words, patients don’t tend to co-operate with studies on their breast implants. This was the case when we the doctors were forced to administer these studies as well. Patients also are not willing to spend thousands on post-surgery MRI scans that their insurers refuse to cover. These MRIs are not happening making the requirement practically unenforceable.
Now the FDA is thinking about a Breast Implant Registry probably for just silicone gel breast implants. Although the FDA has supported their previous statement that these implants are “safe,” they haven’t indicated what that really means. They also have yet to indicate how they will get the patients to actually show up for their studies.
“We believe it’s a good idea to have a conversation about a breast implant registry. … (But) we believe implants are safe and effective and should remain on the market,” Dr William Maisel, deputy director of the FDA’s devices division, told reporters after the meeting. In 2006 the FDA approved silicone gel-filled breast implants sold by Allergan (AGN.N) and Johnson & Johnson’s (JNJ.N) Mentor unit on condition both companies follow 40,000 women for 10 years to look at safety issues, as well as extend smaller pre-approval studies.
I use many more saline-filled than silicone gel implants. I believe they are safer. They require no MRI scans afterward, no special FDA mandated consent paperwork and much less worry about follow-up. Simple.
John Di Saia MD
Reader Laura’s Comment:
The FDA has announced that the makers of silicone breast implants have not been following up with the women who have received them as requested when they re approved silicone implants. How long can a woman safely have their implants in before they should have them removed or replaced? Is 10 years the norm? Do you have specific time in mind for replacement when the implants are first but in? Do you recommend that your patients get MRIs?
Makers of silicone breast implants have not followed up on thousands of women who received them as required by the Food and Drug Administration as a condition of approval, agency advisers said Wednesday. Mentor Worldwide and Allergan Incorporated received FDA approval for their silicone gel-filled breast implants in 2006 after agreeing to do large, 10-year post-market studies. But in a two-day meeting to update two FDA panels on the status of those trials, the companies admitted they had lost track of large numbers of women after implantation.
Silicone gel breast implants leak small amounts of silicone gel into a patient’s body over the time in which they reside there. There has never been much of an argument there. The real question is whether or not this is well tolerated. The answer is sometimes more than others. It has always left me a bit unsatisfied when implant makers and their spokespeople have stated that silicone breast implants are “safe.” What does that really mean? I recommend silicone breast implants for a small minority of my breast implant patients when their risks seem warranted by benefits. I do not call them “safe” however.
If my wife were to have breast implants she would be having saline-filled models. My opinion is that they are much safer over time.
On the subject of breast implant studies, most patients simply don’t like them. For years we tried to follow our silicone breast implant patients for purposes of follow-up studies. This was back before the FDA made study administration the implant manufacturer’s problem again. The average patient has little interest in coming in for re-evaluation unless there is a problem. Blaming the implant companies for lack of follow-up in this light is not fair.
On the longevity of silicone gel implants, that is an unknown. The newer generation “gummy bear” implants have not been around that long. I think replacement over a ten year cycle is probably conservative, but patients do not always stay with the same surgeon for ten years and that cycle time is not standard.
Breast MRIs are recommended for silicone gel implant patients at intervals but few of these women get them. Breast MRI studies are expensive and health insurance does not cover them usually. In fact, a woman admitting that she has breast implants can get her insurer to refuse to extend policy coverage or rescind it in many cases.
Silicone gel breast implants are controversial and by the looks of things are going to stay that way for the foreseeable future.
John Di Saia MD
The FDA sought the withdrawal after receiving new data showing that the drug put patients at risk for potentially fatal heart rhythm abnormalities, the agency said. “These new heart data significantly alter propoxyphene’s risk-benefit profile,” the FDA’s John Jenkins said in a statement. “The drug’s effectiveness in reducing pain is no longer enough to outweigh the drug’s serious potential heart risks.”
Darvon and Darvocet are not uncommonly used pain medications. Patients with side effect issues with Vicodin are put on it pretty commonly. The key ingredient in both is propoxyphene, a relatively weak narcotic.
Apparently over the last few years studies in Europe have indicated potential heart arrhythmias. It was pulled in Great Britain six years ago. Should it have been pulled in the US sooner? I am sure lawyers looking to line their pockets with cash will be saying so. On the other hand, when you have a drug that has been on the market for such a long time, how much data do you need to pull it? That all depends upon the data and we are not looking at that data. I have never seen a patient develop an arrhythmia problem on it however.
John Di Saia MD
Originally posted 2010-11-20 12:00:11.
Federal health officials approved the wrinkle-smoothing injection Botox for migraine headaches on Friday, giving drugmaker Allergan clearance to begin marketing its drug to patients with a serious history of the condition. The FDA approved the new use based on two company studies of more than 1,300 patients who received either a Botox injection or a dummy injection. Patients who received Botox reported slightly fewer “headache days” than patients given the sham treatment.
This reminds me of the media blast when Botox was approved for cosmetic wrinkle reduction. I have been using Botox and other botulinum toxins since 1997 off label. It was plainly apparent years ago that migraine patients had fewer headaches and they would come for both the cosmetic benefit and the headache treatment at the same three month interval.
The FDA will not tell you that Botox and the other toxins work very similarly. I have been using Myobloc for my patients for years and I actually like it better. It works well for migraines too although as a plastic surgeon I am only supposed to give it for wrinkles. Kinda silly.Although we have used it for Migraines for years, only now is Allergan allowed to market it to migraine patients. That is silly too.
John Di Saia MD
The drug was initially approved after a study found that, by preventing blood flow to tumors, it extended the amount of time until the disease worsened by more than five months. However, two new studies have shown that the drug may not even extend life by an extra month.
The FDA advisory panel has now voted 12-1 to drop the endorsement for breast cancer treatment. The panel unusually cited “effectiveness” grounds for the decision. But it has been claimed that “cost effectiveness” was the real reason ahead of reforms in which the government will extend health insurance to the poorest.
I am amongst the first to rail when healthcare finances turn socialist, but this might just be a drug with questionable effectiveness. If the feds just decreased what they allowed the drug company to make from the sale of the drug (like they do with Medicare payments for doctors and hospitals,) then this would all likely sort out. $8000 a month for one drug is steep particularly if there is a question as to whether or not it works.
John Di Saia MD