According to the official notification, the company may “talk to interested parties about the possibility of EVOLENCE® market re-entry under different ownership.”

They also assured physicians that EVOLENCE was, and remains, an “effective option” for wrinkle reduction, with a “favorable safety profile.” The news however, is puzzling when you consider how short the drug’s lifespan was in the United States.

Was EVOLENCE® destined to fail?

An Israeli company called ColBar LifeScience was responsible for development of Evolence, and they had been marketing the drug outside the U.S. since 2004.

When Johnson & Johnson acquired the company and received FDA clearance for Evolence in the summer of 2008, they were optimistic about the filler because of its unique composition of naturally sourced porcine collagen.  Evolence was radically different than the popular hyaluronic acid offerings that dominate the market; it had all the benefits of the old collagen fillers, lasted longer, and required no allergy test.

However, some experts predicted a struggle for the animal-based collagen filler. The Wall Street Journal quoted J&J consultant Kenneth Beer saying, “they couldn’t have picked a worse time [to enter the market.]” Others expressed concern about the drug’s source: “Porcine products historically haven’t done well, and many people prefer lab-grown products,” said analyst Ronny Gal in a 2008 report.

It might be a stretch, but could it be fear of the swine flu and all things porcine that killed Evolence?

The idea of the informed consent came about because of this exact thing.  Years ago surgeons were viewed as authoritarians so patients asked few questions and accepted whatever was performed.  The problem was that patients weren’t always emotionally ready for the outcome.  But times have changed and medicine as evolved.  Today there are basic rules for informed consent that center around explaining the risks and benefits of each procedure.  But for me and the 99% of other conscientious surgeons this only forms the basics of consent.

My approach to each and every patient is education.  This means describing in complete detail the procedure to be performed, from incision to closure.  Every reasonable risk and complication is spelled out in a bound booklet.  So my patients aren’t surprised after surgery.  This isn’t to say there are “gray” areas.  For me these “gray” areas consist of things like: slightly more dissection or a few more stitches needed to get the surgery perfect.  This is opposed to these arrogant surgeons who feel they can do whatever they want, for what ever purpose.  Perhaps they realize during surgery that what they planned wasn’t right, extensive enough or what they thought the outcome would be.  Whatever the reason it’s wrong to perform surgery, in a non-emergent or urgent way, without the consent of the patient or family!

As surgeons we have an obligation to educate our patients so they understand, well, what to expect.   Unexpected things can and do happen during surgery but these should still be within the realm of the planned surgery.   I pride myself on being forthcoming and the surgeon you choose should as well.

Hi Dr. Hess,
I’m considering a tummy tuck and wondering if I should work out my stomach muscles beforehand, or wait until the surgery is complete.  Should I wait?
J.A.

Well, it depends on whether abdominal workouts are part of your normal routine.  If the surgery is in the near term, say under 4 weeks, then I would not advise you to start exercising your abdominal muscles.  It’s never a good idea to drastically change your routine before surgery,

If surgery is planned several months down the road, then some mild exercises to strengthen the abs may be just fine.  However, I think working the cardiovascular system is more important.

If you already have an exercise routine, then by all means continue it; make only the changes that you would normally make.  Overall, you don’t want to be dehydrated, sore or otherwise debilitated from the exercise.

If a saline breast implant fails it’s usually pretty obvious.  If the implant develops a catastrophic failure then the implant will fail like a tire blow out.  And it’s inevitable that this will occur when you’re getting ready to go out for a dinner party or the like.  Occasionally the implant will develop a small leak that is only obvious after it has been leaking for several days and the volume decreases enough to appreciate.  In either case it’s important to make an appointment with your plastic surgeon as soon as possible to avoid having to wear extra padding in the bra.

If a silicone breast implant ruptures you’ll never know it.  The reason is that the capsule that develops around the breast implant will contain the silicone gel.  In the older style implants some of the silicone oils could migrate through this capsule.  However, silicone is inert and this oil did not result in any disease or disorder (contrary to popular claims made by the media).  Today the cohesive gel implants that we use have silicone that does not migrate and thus are even safer than the previous implants.  And if you have any concerns, the “gummy bear” implant should ease your mind.

If the saline breast implants rupture, then the breast implant repair process is simple.   The old implants are removed and new implants of equal size are inserted.  The surgery should be performed within a few weeks of rupture to prevent contracture of the pocket.  If a breast lift or other procedure is necessary, that can be discussed with your surgeon.  If a silicone breast implant ruptures it’s a sticky, gooey mess.  The capsule and implant should be removed together if possible, but that is often impossible and removal of the old silicone can become tedious.  Once all of the silicone gel is removed the new implants – silicone or saline -  can be put in place.

While it may be stressful, don’t worry when your implant ruptures.  There’s time to correct the situation and return your breasts to their previous state.  Call Dr. Hess at 703.752.6608 and he’ll help you regain the appearance you desire.

While Botox is typically used – and FDA approved – for treating wrinkles on the face and forehead, a wide range of other applications have been successfully performed.  Doctors have used Botox to treat hyperhidrosis, migraine headaches, muscle spasms, and many other problems.

According to current U.S. law, physicians are allowed to administer medicine for whatever use they deem appropriate.  They aren’t however, allowed to advertise or market medicine for any application under the sun.

The marketing restrictions placed on off-label Botox have evidently hindered Allergan’s ability to distribute safety information related to such uses.  The current lawsuit is intended to increase the physician’s ability to access safety information such as possible risks, benefits, dosing, patient selection, etc. and is in no way intended to boost Botox sales.

Read more about Botox Cosmetic.

This question is inherently flawed. Can anything at all be a viable solution to aging?  Unless you’re optimistically waiting for developments in stem cell research, the aging process is a fact all of us must accept.  So, perhaps the word “solution” is misleading; we don’t have a “solution to aging,” but we do have options.

Options for dealing with the cosmetic effects of aging are highly individualized.  One person might be completely satisfied simply with “great skincare, clever makeup, and an amazing haircut” – but that doesn’t mean you or I need to be.  This concept of individuality seems to be an underlying point of contention between these two journalists.

Ms. Jones naively asks, “What’s the point of having work done if you end up looking like an identikit version of every other woman in your doctor’s surgery?”  She assumes that plastic surgeons aim for some objective, ideal form of beauty, with no concern for the patient’s autonomy or individual aesthetic.  As any good cosmetic surgeon should tell you, this assumption is way off the mark.

The goal of cosmetic surgery is to enhance a person’s individual beauty, at least in part, according to that person’s desires.  The end result will always reflect a combination of three things: the patient’s goals, the patient’s natural characteristics, and the surgeon’s aesthetic sense.  Cosmetic surgery just isn’t as simple as many would lead you to believe.

Where do we draw the line between reasonable and excessive cosmetic interventions?  Ms. Hart-Davis refers to “a slippery slope on which everyone will have their own stopping point,” and she’s correct; trying to make a distinction between cosmetic interventions that are deemed acceptable or not acceptable will likely use some arbitrary criterion, so the distinction must ultimately be made by the individual.

However, Jones employs the same “slippery slope” concept in absolute terms saying, “once you start [cosmetic surgery], there’s no going back.” It is unclear whether she means to argue that there is no “stopping point” or that there’s no returning to your “real” self once you’ve begun.

First of all, each individual can decide when enough is enough.  Second, because aging and life change our bodies and selves over time, there’s no “going back” for any of us.

I could continue picking apart both sides of the argument, but perhaps it would be more interesting to hear what our readers think: is cosmetic surgery a viable option for you?

1. Better Breasts
Clearly the main goal of cosmetic breast surgery – participants of the study commented about improvements in breast shape and the clothing options that were now available to them as a result.  One patient with breast implants comments, “Some things are much more fun to put on, and the stuff that I used to wear looks way better–I am sure they looked good before, too–but I just fill in a bit more, look a bit more busty in them.”

2. Better Physical Well-Being
Breast reduction patients can get relief from back and neck pain, which often allows increased activity and better health.

3. Improved Psychosocial Well-Being
Patients in the study shared the positive changes in self perception and experiences in social settings. Increased confidence and feeling as if you fit the perceived “norm” of the female body are said to be a common benefits of breast surgery.

4. Improved Sexual Well Being
When people feel more attractive, they generally experience more sexual pleasure.  If breast implants or another surgery improve a woman’s perception of her self and her body, sexual well being can consequently improve.

5.  Great Surgeon-Patient Relationship
Women who experienced a good surgeon-patient relationship – with open, honest communication – expressed more satisfaction with breast surgery.  Patients who had an adverse relationship with the surgeon or staff reported being fearful, uncomfortable, and less satisfied.

6. Overall Satisfaction
Researchers also included the simple category of general satisfaction.  Would you undergo the surgery again?  One breast augmentation patient responds, “there is not one day that goes by that I am not so pleased that I did it.”

The article referenced is called “Satisfaction and quality of life in women who undergo breast surgery: A qualitative study” and you can find it here on BMC Women’s Health.

Here are two questions for our readers:

• Are there goals you have considered for breast surgery that aren’t listed above?
  
• If you have undergone a breast lift, breast reduction, reconstruction, or augmentation, were there additional benefits (or influencing factors) that these researchers haven’t identified?

This series was put together so that perhaps more patients and surgeons will appreciate the numerous areas that must to be considered before choosing the correct breast implants.   Determining the correct implant must be a collaborative effort between patient and physician.  Use your surgeon as a guide. Use his or her knowledge, sizers, and experience – but trust the knowledge you have and your own personal desires to make decisions.

In these cases I not only encourage but insist that patients see me for an additional appointment or more until they are confident in the choice of implant. Although most surgeons don’t do this,  I feel that it’s our duty to educate patients until they are comfortable with their decision.  During these visits it is important to bring multiple different outfits so you can see the full effect the surgery will have.  And as I’ve said before, a sports bra will give the best compression with the sizers.

So don’t be afraid to visit your surgeon on separate occasions until you’re comfortable choosing the correct breast implant.

But many patients like the support that a friend or significant other can provide during a consultation.  This is a very good thing because as I said, patients don’t always hear or remember everything that I tell them. Having a friend or significant other with you during the consultation adds another set of ears and thus increases the amount of information that is obtained.  It’s also good for them to take notes while we talk thus increasing even more the amount of information gained.

In addition, these friends, if they understand your desires, can lend another set of eyes that can help determine the best breast implant.  This is slightly more touchy because they must be able to put aside their own personal preferences for the sake of the patient.  But a true friend or significant other can still be quite helpful when choosing the correct breast implant.