An exercise in clock watching - the fda's review of Allergan's 410 "gummy bear" breast implants

As the plastic surgeons of the United States await approval of Allergan's style 410 breast implant (aka "the gummy bear" implant), I frequently get questions from patients about when this device will be approved.

The short answer is "I don't know!"

The approval of medical devices of all sorts has been heavily politicized. After a number of recent high profile issues with prescription drugs, cardiac pacemakers, and vascular stents (devices used to prop open clogged blood vessels or fix aneurysms), the FDA is under the microscope. Caught up in all this is the fate of the next generation of breast implant devices, for which the FDA has been sitting on the manufacturers approval applications for nearly 3 years.

For some context, "form stable" implants like Allergan's 410 have been used clinically around the world for over 15 years. In clinical trials (like this)they have an unparalleled safety record for this kind of medical device, and offer both superior durability and a reduction in every single kind of indexed complication (pain, capsular contracture, rippling, rupture, etc...) after cosmetic and reconstructive breast surgery that we observe and track.

Allergan's Style 410 implant:


The NY Times reported earlier in April (here)on the ongoing reexamination of "legacy" devices that were exempted prior to the late 1970's from review as they were already being used. Silicone and saline breast implants actually already went through this review by the FDA in the early 1990's and eventually emerged with a clean bill of health. The only reason the newer implants have to go thru this process at all is the higher cohesiveness of the silicone polymer exceeds some artificial cut-off that would make them fall under the existing approval. This illogical rationale has cost tens of millions of dollars to companies and delayed patients access to improved devices.

As to the fate of the 410 implant, my understanding is that the FDA is satisfied with the safety and clinical efficacy of the implants and is negotiating on the final labeling to be included with the product. Apparently, surgeons will be required to attend an instructional course prior to being given access to the device (even someone like me who actually used these devices as a resident and fellow during clinical trials). We are hopeful that the ongoing activity signals approval is immanent this quarter!


Rob

A Partisan's political pandering poised to poison prevention - Why Rep. Waserman's breast cancer bill is wrong.

That was a heck of the title, eh? My little pun on the "6 P's" ;)

Of all medical diseases, few are surrounded by as much politics as breast cancer. After all, who doesn't want to advance the treatment of breast cancer? The problems arise when feel good political ideas triumph over evidence based medicine and you end up with legislation which is almost sure to cause as many problems as it solves.

Enter the boldly titled "Breast Cancer Education and Awareness Requires Learning Young Act of 2009" (EARLY Act) introduced by Rep. Debbie Wasserman Schultz (D-Fl). For whatever reason, Rep Schultz is one one of the single most obnoxiously partisan members of congress and gets on my every last nerve when I come across her on television. Schultz's bill seeks to spend $45 million over five years to start educational campaigns that would include promoting regular breast self-exams to secondary school students, even though the this has been proven ineffective and quite possibly harmful in clinical trials.


Breast self-examination may seem an innocuous and intuitive way to assist the self-detection of breast cancer except for the fact that IT DOES NOT WORK when applied on large populations of non-selected women. All young women have dense lumps and bumps in their breasts tissue which represent fibrous breast tissue or benign cysts that become symptomatic with their menstrual cycles. Recommending breast self-exams to this group of women will cause fear, many expensive negative imaging studies, false-positive results of various screenings, and many unneeded biopsies.

There's some math you need to think about with these younger women. The probability that a woman who is age 15 years will develop invasive breast cancer by age 40 years is less than one-half of one percent (0.497%). This can be compared to a 5% probability that a 50 year old woman will develop breast cancer by age 70 years (5.62%). The American Cancer Society reports that during 2000-2004, only 5% of new cases and 3% of breast cancer deaths occurred in women under 40 years of age. For women aged 20-24, there were only 1.4 cases per 100,000 women. The goal of an effective screening program is to find disease and save lives. Unfortunately, at the end of the day there is no effective method of detecting breast cancer in a healthy population of women under 40.

Other then family history, we're currently left with little other then some of the expensive genetic tests (like BRCA1 & BRCA2)to try and select out people for closer surveillance. Despite the strong association between BRCA mutations and breast cancer (where as many as 85% would be expected to develop invasive breast cancer), only 5-10% of all breast cancer patients have BRCA1 or BRCA2 mutations. This again gets back to the difficulty in effective screening.

Leslie Bernstein PhD of the City of Hope Hospital in California published an open letter to legislators considering this bill to explain why this is a poorly aimed directive and likely to cause more problems then it solved. The letter can be read here. A better public policy goal in my opinion would be to mandate insurers and Medicare to cover breast MRI for screening in high risk women.

Rob

Will the last of the Dow Corning breast implant plaintiffs please turn out the light!

The Star (UK) reports (here) on a plaintiff from the 1980's class action lawsuit against Dow-Corning involving silicone breast implants who finally received her share of the remaining settlement for a grand total of £207 ($304.50 USD at today's exchange rate).

It's hard to believe that elements of the 2nd or 3rd biggest "whale" of American class action lawsuits are still in existence. I call it 2nd or 3rd because asbestos and tobacco suits have dwarfed it now in overall compensation (Don't even get me started on the claims that smokers had no idea they could get addicted to cigarettes or get lung cancer!). The shenanigans of the trial bar in our country cultivating these proceedings does not reflect well on our legal system.

The person in the Star article had what sounds like subcutaneous mastectomies for painful breast cysts and reconstruction with silicone implants. She's attributed multiple and diffuse symptoms to the fact she had silicone breast implants in. (Keep in mind, large databases of women around the world with implants have failed to demonstrate an increase in any common rheumatologic symptom.)

She was among thousands of women from the USA and Europe who took action against the company claiming their health had been damaged after their silicone breast implants leaked or caused immune system reactions.

Now more than a decade of waiting the cases have finally been settled.

"It is an insult, they might as well have given us nothing at all," said Shirley. Women were originally expected to received thousands of pounds in compensation when the action was first launched. But Dow Corning, which did not admit liability in the legal case, went into bankruptcy and the amount of compensation available fell.

Well, if you believe the overwhelming world scientific consensus (see here) that has shown no linkage of any identifiable disease to breast implants , you might make the argument she received £207 too much. What's most striking is to consider how much the handful of class action plaintiff's lawyers literally stole from investors of Dow Corning (hundreds of millions of dollars) and how little claimants received some 20 years later.

Rob

Plastic Surgeon goes CSI to bust Booby bandit!

From NBC comes this story:

"Yvonne Jean Pampellonne, 30, allegedly used a fraudulent identity to pay for liposuction and a breast implant exchange, according to the Huntington Beach Police Department. The total cost of the surgeries is valued at more than $12,000.

The Laguna Niguel woman is accused of opening a line of credit in someone else's name in September 2008, having the procedures and then never showing up for any follow-up appointments, police said."

The plastic surgeon who'd been defrauded for cost of the procedure apparently didn't take this lying down. They hadn't yet disposed of the patients old breast implants (which were exchanged during the procedure) when the fraud was discovered. They used the serial number imprinted on the old implants to track her down to her previous surgeon's office, and identified her via photos from the other office. I love it!

If you would like to "friend" Ms. Pampallone on MySpace, her profile can be found here. Apparently Ms. Pampallone was unfamiliar with myfreeimplants.com as she might have saved herself a multiple felony convictions.

Rob