This is a great story about a new online bra company called True & Co., written with the wonderful snarkiness of Jezebel:
This is important because patients ask for a specific cup size. They even will specify to such vagaries as, “somewhere between an upper medium C and a small full C,” or something totally undefinable and unattainable.
There is no standard in bra manufacturing sizing, different bra sizers at the various department stores will suggest different sizes, and but one difference in band size changes the cup by an entire size.
If you haven’t heard about the woman with three boobs, it is an interesting story.
The problem with the story is that it isn’t true; it is just a hoax. How do I know?
Because it is impossible to make a perfect third breast in the center of the chest because there simply isn’t the skin there to do it. The marvel is that this surgery still has legs despite being obviously false.
At the time of cohesive gel implant FDA approval a couple of years ago, Mentor only initially received approval for one shape in its range of implants. Why? Because they only tested one shape in their trial.
Allergan tested 4 of its twelve shapes and only got those four approved. But Sientra got all approved.
Why is that? Because Sientra is focused on one device and its regulatory consultants know breast implant manufacturing very well.
Allergan and Mentor/J&J farm out their breast implant-related regulatory stuff to other people in their company who do not know breast, and hence they failed. This is but one more example of the problems that occur when big businesses buy small businesses and apply economies of scale.
One shudders to think what will happen to the great pipeline of Allergan implants if Valeant Pharmaceuticals succeeds in their hostile takeover. They have expressly stated that their ONLY responsibility is shareholder value, and that they achieve it by increasing margin and not doing any R&D.
Kudos to them on a job well done. And they are the only breast implant company to restrict their sales to board certified plastic surgeons.
The truth is that the breast implants themselves are given too much credit and blame for the outcomes, while data using different implants is roughly the same with the same surgeon and data using the same implant varies between surgeons.
We all wish them continued success. We just hope that they do not get bought out by a bigger company that will squeeze the juice out of them like an orange and run the business into the ground in an effort to maximize margins.
Sounds impossible? Just witness what happened to Mentor since it was bought by J&J and wait and watch what happens to Allergan if Valeant succeeds in buying them.
Dr. Teitelbaum was interviewed by the New York Times for a controversial piece about some surgeons using saline injections to temporarily enlarge the breasts for 24 hours.
Dr. Steven Teitelbaum, a plastic surgeon in Santa Monica, Calif., and an associate clinical professor of plastic surgery at the U.C.L.A. School of Medicine, called the saline solution unnecessary. “Between good bras and chicken cutlets, you can always look good in clothes,” he said.
Read the full article in the New York Times: What a Difference a Day Makes, August 21, 2014
Dr. Steven Teitelbaum featured on RealSelf TV in 2013 candidly answering the question, “Gummy Bear or Regular Breast Implant, Which One is Right for Me?”
When interviewing plastic surgeon about their level of experience with gummy bear implants, here are 7 questions you should ask.
- How long have you used gummy bear implants?
Checking for the surgeon’s knowledge of long term issues
- Have you used over a hundred pairs of them?
Never ask how many a surgeon has done because he or she actually won’t know. But 100 is a key number and by watching their reaction you should be able to know whether they’ve done that many.
- How do you pick the implant size?
They should tell you that they measure before surgery…important for all implants, critical for gummy bears
- What are the biggest advantages of gummy bear implants?
Answers are shape, not rippling, resistance to breakage
- What do you see as the biggest trade-offs of gummy bear implants?
Answers are firmness, risk of rotation, longer incision, higher cost.
- Can gummy bear implants break?
If the surgeon says they can’t, head for the door.
- Between Mentor, Allergan, and Sientra, which one do you suggest for me and why?
It is a hard question and there is not one answer. But how they answer will demonstrate their understanding of the nuances of these devices.
20 years since it was introduced in Europe and nearly 12 years since clinical trials began in the United States, the Allergan Style 410 breast implant received FDA approval on February 20, 2013.
Prior to this time the 410 was available only to American women participating in clinical trials. Enrollment was limited to small numbers of patients, and could only be used by a few surgeon investigators nationwide.
This is the single most studied breast implant in history, with dozens of publications and thousands of patients enrolled in research studies. These papers demonstrate the best safety profile of any implant yet studied.
FDA approval of the 410 has been long anticipated by plastic surgeons and patients. Though the design concept has been imitated, the 410 has a loyal following of breast surgeons worldwide.
Several hundred thousand women have received this implant worldwide. Perceived advantages are a better shape; a natural appearance; virtual freedom from shell folds; durability and longevity. Trade-offs are firmness; a risk of rotation; and a higher cost.
Women who are seeking proportionate and natural looking breast augmentation with the highest level of shape control and lowest risk of implant folds are generally the best patients for these implants. Those wanting either disproportionately large implants or the softest implants are often better candidates for standard silicone gel implants.
This is the first new product for augmentation and reconstructive breast patients since the FDA approved standard silicone implants 6 years ago. Patients now have more choices to optimize their surgical results.
The only frustrating part of today’s announcement is that with this implant approved, there are no new types of implants left in the pipeline awaiting approval. This implant was to have been approved 3 years after the commencement of the study. Given the politicization of the breast implant process, whether another manufacturer will take the risk to develop an even newer generation of breast implants is anyone’s guess.
The newest generation of highly cohesive gel breast implants comes in variable widths, heights, and projections. This means that the outdated concept of selecting an implant based on volume alone will not work with these newer shaped implants. Shaped highly cohesive gel breast implants should be selected based on your individual dimensions and tissue type:
- The width: the implant selected should match as closely as possible to the base width of your breast.
- Height: the height is selected based on several factors including the distance from your upper chest to your nipples as well as the shape of your upper chest.
- Projection: the projection of the implant is determined by the quality of your tissues. Women’s breast tissue and skin can vary from very tight and firm in a young woman with no children, to very loose and empty in women who may have lost weight or breast fed several children.
It is most important to understand that there may not be one best breast implant for any you, but their will be a small range of implants that may all work well. Your individual desires and goals should be considered, but an experienced plastic surgeon will help guide their patients to select an implant that best matches their breast dimensions and tissues. The use of 3-D imaging may also be very helpful in the pre-operative implant selection process.
Article by Caroline Glicksman, MD, Sea Girt, NJ