Denver Cosmetic Surgery Blog.com

It’s long been a tradition in medical practice to use FDA approved therapies in new, “off-label” ways. Is this safe? Botox, a treatment so prevalent as to have become synonymous with cosmetic medicine, is approved to treat four problems: muscular eye disorders, muscular neck disorders, excessive sweating (hyperhydrosis), and frown lines or wrinkles between the eyebrows. Yet, it is common practice for clinicians to use Botox in a myriad of other ways. Botox, a butulinum toxin isolated from bacteria, works by locally paralyzing the region where it is injected. A new version of this toxin, Dysport, has recently been approved as well. With botulinum toxins, doctors have had success treating anal fissures, pelvic muscle spasms, chewing problems, migraine headaches, and in the world of anti-aging therapies, ridding the aging face of crow’s feet and wrinkles around the mouth.

Is it reasonable to adopt novel uses of these drugs before rigorous study under governmental supervision establishes the appropriateness of such therapy? Doctors are entitled to employ FDA approved therapies in unapproved ways based upon their experience with their use. For patients and clinicians alike, it seems difficult to discern whether off-label use of these treatments is a reasonable therapeutic leap based upon the safety and practice guidelines already established or if it’s just experimentation on the unsuspecting public. 

I recommend that anyone considering off-label treatments of an approved medical device or medication consider the following:

1) Ascertain why the treatment has not been approved for the proposed use. Silicone gel breast implants were reapproved by the FDA in October, 2006. However, they are not approved for women under 22 years of age. This is clearly not due to a lack of device testing or understanding of gel implant safety. A gel implant would not be less safe in a 21 year old as compared to a 22 year old. The imposed age restriction on approved usage of these devices implies that the FDA is suggesting an age-related degree of maturity necessary to make this particular decision. If I meet a mature, self-aware, 21 year old who has well thought out her desire to have silicone gel implants, this may be a reasonable off-label use of these devices.

2) Determine if the clinician has an extensive history of using the treatment. In the example of Botox, a clinician who has injected many people for brow furrows would have a particular aptitude for safely determining Botox usage in other areas of the face. 

3) Ask if there’s a substantive, theoretical basis behind the proposed therapy: it’s efficacy and safety. We know that Botox paralyzes muscles locally. There is voluminous evidence that Botox rarely effects areas distant from the treatment site unless used in extremely large doses. Because of it’s mechanism of action, the present data on the local therapeutic affect, and the miniscule side effect profile, it is theoretically reasonable to treat local disorders related to muscle tightening or spasm at appropriate doses.

4) If the therapy is a medication, ask if it’s off-label use proposed is in similar doses to it’s approved use. 

The debate over off-label device and drug usage will not be solved any time soon. The FDA restricts companies who make medical treatments from promoting their non-approved applications. Allergan, the manufacturer of Botox, recently filed a law suit against the federal government claiming that this restriction violates their First Ammendment rights to speek freely with doctors regarding the promotion of their drug. We’ll see how this plays out. Meanwhile, clinicians can and will continue to use Botox in non-approved ways: ways that are in great demand and improving the quality of life for many people. While this should not trivialize the  FDA’s role in safely regulating medical treatments, patients can continue to benefit from off-label drug applications as long as they are involved in the process of determining the appropriateness of such usage.

Many young moms that I see for surgical consultations are using the catchy terminology, “mommy makeover”. A “mommy makeover” generally refers to a combination of surgeries to include an abdominoplasty (tummy tuck) and a breast procedure. Some women opt for a breast augmentation, while others need a breast lift or even a breast reduction. The combinations of these procedures can be performed safely, allowing for one recovery and less expense.

So if you’re contemplating the post-baby plastic surgery plunge, here are a few considerations:

1. Be sure you’re down to your pre-pregnancy weight, or at least the closest you can manage with your new, hectic lifestyle. Although a tummy tuck will go a long way towards restoring your pre-baby belly, it’s not a weight-loss tool.

2. Consider postponing your post-pregnancy tummy tuck and breast plastic surgery until after you’ve completed your family. Having more children after these procedures can undo the results leaving you wanting further surgery. 

3. Be sure to check out the Internet for before and after photos to get a realistic idea of your expected results. Yes, you’ll look better, but you’ll have some scars along with your transformation. A skilled surgeon can hide the scars that will fade considerably with time, but some scarring is inevitable.

4. Choose your plastic surgeon wisely! He or she should be Board Certified by the American Board of Plastic Surgery. You can confirm this by checking on the American Board of Plastic Surgery website. Don’t settle for less. This is your body and surgical changes are permanent. You want to be sure you’re in capable hands.

5. If you’ve likely completed your family, thoroughly screened your prospective plastic surgeon, established a support system for your recovery, and reviewed post-surgery photos, there’s only one consideration left: where to buy the bikini you’ll surely want to wear after your procedures.

Dr. Vath

On October 12, 2009, the “Donda West Law” was signed by Arnold Schwarzenegger in California. The law states that “medical clearance” is required prior to undergoing elective cosmetic surgery. As a Board Certified plastic surgeon who performs primarily elective cosmetic surgery procedures, I have some concerns about the meaning behind the need for this legislation. But first, let’s review what we know about the Donda West incident that occured in 2007.

Mrs. West underwent a combination of cosmetic procedures by plastic surgeon, Dr. Jan Adams, including breast and abdominal surgery. Dr. Adams was the host of Discovery Health Channel’s Plastic Surgery: Before and After and frequently featured cosmetic surgery expert on the Oprah Winfrey show. Dr. Jan Adams is not certified by the American Board of Plastic Surgery. Prior to seeing Dr. Adams, she was reportedly denied surgery by another plastic surgeon due to health concerns. The day following her surgery, Mrs. West was found unresponsive, taken to Centinela Freeman Regional Medical Center in Marina del rey, California, and died. We do not know the truth about her medical condition and risk factors prior to surgery nor do we know the precise cause of her death. According to the autopsy report, “the manner of death could not be determined”. The Medical Examiner ultimately attributed her death to “pre-existing coronary artery disease and multiple postoperative factors” including aspiration, pneumonia, pain medication, and tight compression garments. 

Many have heard about this tragedy and assume someone is to blame. Is the surgeon at fault? Should Mrs. West have been “medically cleared” prior to her operation? Her risk factors for surgical complications certainly should have been assessed, but by whom? And were they? Although Dr. Adams is not Board Certified, we can’t determine that he acted improperly. But this incident highlights several issues about cosmetic plastic surgery in our society that I believe need to be addressed.

The key to minimizing the risk of elective cosmetic surgery is based upon three recommendations made by the American Society of Plastic Surgeons: a) the surgery is performed by a properly trained and Board Certified plastic surgeon, b) the surgery is performed in a safe, appropriately accredited surgical facility, and c) the patient is healthy. We know that Dr. Adams is not Board Certified by the American Board of Plastic Surgery. I do not know if the procedures were performed in an accredited operating room. And I do not know if Mrs. West had preoperative health problems, despite rumoured suspicion that she did. Would the new Donda West Law’s requirement for “medical clearance” have helped? To answer this requires some understanding of “medical clearance”.

In the surgery world, “medical clearance” refers to the evaluation from a non-surgical doctor as to the safety of a patient undergoing a proposed operation. That doctor will take a history, evaluate known medical conditions, perform a physical exam, and obtain any testing to follow up on health concerns. This sounds reasonable. But to mandate that all patients seek “medical clearance” from an internist or family practice doctor ignores the fact that plastic surgeons are medical doctors as well and ultimately responsible for engaging in a surgical relationship with a patient. The truth is that all surgeons should be able to identify risk factors for surgical complications and implement the appropriate preoperative screening such as an EKG and basic blood tests. And all surgeons should know when a medical consultation is necessary to further evaluate concerns that are beyond their expertise. Absolutely, there is a place for medical specialty consultation and I frequently request them, whether it’s from an internist, a cardiologist, a rheumatologist, a neurologist, a nephrologist, or whichever specialty makes sense. However, even with proper preoperative evaluation from the plastic surgeon, other doctors, or both, complications from surgery will still happen. We don’t know if Mrs. West had any health problems that were identifiable in a thorough medical evaluation. She may have had the appropriate evaluation and still suffered a tragic result. Asymptomatic coronary artery disease would often not be identified in a history, physical, and EKG. Although “medical clearance” may identify those at risk or who should not have surgery at all, patients that are “cleared” are not guaranteed a safe outcome. Nonetheless, it is reasonable to assume that mandatory “medical clearance” would serve as another layer of protection for patients, especially for those choosing surgeons that don’t take the safe course of action on their own. I would argue that a Board Certified Plastic Surgeon is more likely to take the appropriate safety precautions including a consultation with a medical specialist when necessary. So, why did Donda West choose a Plastic Surgeon lacking these basic credentials?

Although not Board Certified, Dr. Adams has been celebrated on the Oprah Winfrey show and the Discovery Channel as a famous expert on plastic surgery. Similarly, perhaps the most well-known plastic surgeon in America, Dr. 90210, Robert Rey is not Board Certified. Yet, he appears in the media on TV channels such as CNN to field questions as the plastic surgery expert. We live in a country where media fame counts more than credentials; where privileges associated with popular culture trump ability. We live in a country where those in the inner circle of former NASDAQ Chairman, Bernie Madoff, chose to invest with him depsite never having received a true investment transaction statement. And we live in a country where a doctor on TV is presumed more capable than a doctor with basic credentials verifiable on the internet. I can’t say that this was the impetus for Mrs. West’s chose in surgeon, nor can I say that Dr. Adams acted unsafely just because he never obtained his Board Certification. But before a law mandating preoperative “medical clearance” is instituted, perhaps there should have been a law requiring that only appropriately credentialed surgeons perform specialty surgery? Maybe this would obviate the need to bypass plastic surgeons as responsible physicians in search of another specialty to compensate for the country’s preoccupation with fame and lack of personal responsibility to make safer choices?

Despite these questions, I feel that an additional “medical clearance” requirement for patients prior to any surgery may help save lives. This “Donda West Law”, although not addressing the core issues of proper, safe surgical practice and individual patient responsibility, may ultimately help save some people from bad outcomes. We don’t know if it would have helped Donda West.

Dr. Vath