Tissue Glue Rather Than Drains (?!)

 

Cohera Medical Inc announced the treatment of the first patient in a study of its lead surgical adhesive product, TissuGlu®. Initiation of the study marks a major milestone in the company's progression of the lead product toward clinical practice.

The clinical investigation is a prospective, open-label, randomized study to investigate the safety of TissuGlu and its effect on wound drainage and associated complications in abdominoplasty, or "tummy tuck," surgeries. The study will compare standard wound closure techniques to standard wound closure techniques plus the application of TissuGlu in 40 patients at three sites near Bonn, Frankfurt and Freiburg, Germany.

"We are delighted to have treated the first patient in the TissuGlu study," said Klaus Walgenbach, M.D., Ph.D., of the Universitatsklinikum Bonn and the principal investigator for the study. "We were very pleased with the procedure and look forward to enrolling more patients."

Currently, patients who undergo abdominoplasty require the insertion of drains to remove fluids that accumulate under the skin at the surgical site. In some cases, drainage is inadequate, and the excess fluid accumulation called seroma requires an additional procedure for removal. TissuGlu adheres the tissue flaps created during the procedure to reduce fluid accumulation, and, ultimately, the duration of use of the surgical drains. With the use of TissuGlu, patients may experience a significant reduction of fluid accumulation and a more comfortable recovery, which may lead to a quicker return to normal activity.

"Our transition into the clinical development phase brings us closer to helping plastic surgeons to address a critical unmet need and improve patient care," said Patrick Daly, president and chief executive officer of Cohera Medical. "Furthermore, the market opportunity for our company with TissuGlu is very significant, ranging between $500 million and $750 million from 2011 to 2015. If you add the additional applications such as facelift, breast reconstruction and body contouring that we will pursue with TissuGlu, the opportunity increases to between $700 million to more than $1 billion over the same five-year period."

Chad Coberly, J.D., vice president of clinical, regulatory and legal affairs of Cohera Medical, added: "Initiation of this study culminates significant preclinical work by our company and investigators and demonstrates the primary safety profile of this product. This study will enable us to move closer to CE Mark application in Europe and will provide important data in application for a larger U.S.-based trial in 2010."

Preclinical data published in the July 2008 issue of Plastic and Reconstructive Surgery show that TissuGlu prevented seroma formation in an animal abdominoplasty model. Summarized in a paper titled "Lysine-Derived Urethane Surgical Adhesive Prevents Seroma Formation in a Canine Abdominoplasty Model," (Plast. Reconstr. Surg. 2008; Vol. 122, Issue 1: 95-102) the results demonstrated that TissuGlu successfully prevented the formation of seroma in a novel large-animal model designed to evaluate seroma formation. While the control side in all seven animals used in the study demonstrated large, clinically significant seromas, the side treated with TissuGlu showed little or no evidence of fluid accumulation. In addition, histologic analysis of tissue samples from the animals showed no signs of inflammation or foreign body reaction associated with the adhesive.

"The progress with the development of TissuGlu represents a significant next step in the value creation for Cohera Medical's investors," said Doros Platika, M.D., the company's chairman. "Most importantly, it signifies a potential major advance for surgical patients that may help to decrease complications and improve clinical outcomes."

About Cohera Medical

Cohera Medical Inc. is a Pittsburgh-based company that is developing a revolutionary line of surgical adhesives. Cohera Medical's products are based on a unique chemical design that is purely synthetic, easy to use, biocompatible and fully resorbable. The company's lead product in development, TissuGlu, is an adhesive for plastic surgery procedures. TissuGlu adheres flaps of tissue after surgical procedures, eliminating the spaces where fluid accumulates and reducing wound drainage. Cohera Medical is also developing surgical adhesives targeting mesh fixation, small bone fixation and other plastic surgery indications that will fill similar market needs in plastic, orthopedics and general surgery.

Certain statements made throughout this news release that are not historical facts contain forward-looking statements regarding the Company's future plans, objectives and expected performance. Any such forward-looking statements are based on assumptions that the Company believes are reasonable, but are subject to a wide range of risks and uncertainties and, therefore, there can be no assurance that actual results may not differ materially from those expressed or implied by such forward-looking statements.

Source: Cohera Medical Inc

The Nefertiti Lift with Sculptra Aesthetic Rather than Botox

About one year ago, I reviewed a published article promoting the "Nefertiti Lift" (http://www.pickartplasticsurgeryblog.com/2008/12/the-nefertiti-lift-can-botox-tighten-an-aging-jaw-line.html).  The Nefertiti Lift is a technique for using Botox to rejuvenate the aging jawline and neck.

• My immediate conclusion:  I'm skeptical.
• My conclusion one year later, after having tried the Nefertiti Lift on a number of patients:  Bogus.

However, I have since discovered that Nefertiti Lifts are possible with certain non-surgical products.  Botox just isn't the right product.  Sculptra Aesthetic can--non-surgically--rejuvenate some poorly defined jawlines, baggy jowls, and loose neck skin.

The surgical face/neck lift is still the gold standard.

Spend Your Health Savings Accounts on Plastic Surgery - Only 2 1/2 Months Left

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Most cafeteria plans offer two different flexible spending accounts; one is for qualified medical expenses and the other is for dependent care expenses. A few cafeteria plans offer other types of FSAs, especially if the employer also offers an HSA. Participation in one type of FSA does not affect participation in another type of FSA, but funds cannot be transferred from one FSA to another.

[edit] Medical expense FSA

The most common type of FSA is used to pay for medical expenses not paid for by insurance; this usually means deductibles, copayments, and coinsurance for the employee's health plan, but may also include expenses not covered by the health plan, such as dental and vision expenses and over-the-counter drugs including a first aid kit. A medical FSA cannot pay for health insurance premiums, cosmetic items, cosmetic surgery, controlled substances (in violation of federal law), or items that improve "general health". All items must be intended to treat or prevent a specific medical condition; this can be as significant as diabetes or pregnancy, or as trivial as skin cuts. Generally, allowable items are the same as those allowable for the medical tax deduction, as outlined in IRS publication 502.

The annual caps for a medical FSA varies by employer. Unlike dependent care FSAs, there is no IRS cap on medical FSAs, but employers generally limit the annual amount each employee may contribute,^[1] in order to reduce the risk of pre-funding. Should the employee leave or be terminated and thus no longer pay in to the plan, the employer does not recapture their pre-funding from the employee's payroll deduction.

Flexible Spending Accounts debit card allows for the automatic electronic transfer of pre-tax dollars from an employee account when paying for qualified expenses. Employees are able to receive immediate reimbursement of their medical, dependent care, and commuter expenses simply by using their card at the point of service. The normal paper claims process is eliminated, as are worries of forgotten purchases or lost receipts.

[edit] Plan year grace period

In 2005, the Internal Revenue Service authorized an optional 2½ month grace period that employers can use in their plans, allowing use of the funds for 2½ months after the end of the plan year.

[edit] Use it or lose it

One major drawback is that the money must be spent within the coverage period as defined by the benefits cafeteria plan coverage definition. This coverage period is usually defined as the period that you are covered under the cafeteria plan during the "plan year". The "plan year" is commonly defined as the calendar year.

Any money that is left unspent at the end of the coverage period is forfeited back to the company; this is commonly known as the "use it or lose it" rule. It should be noted and called out for emphasis that under most plans your "coverage period" generally ceases upon termination of your employment whether initiated by you or your employer unless you continue coverage with the company under COBRA or other arrangement. An unfortunate possibility, especially in the case of unexpected, immediate layoff, is that should you have unused contributions in your FSA and no additional qualifying claims during your coverage period you will have the added insult of "losing" these funds. On the other hand, if the payroll taxes saved on the employee's contributions exceeds the amount the employee forfeited, then the employee has still saved money overall.

A second requirement is that all applications for refunds must be made by a date defined by the plan. If funds are forfeited, this does not eliminate the requirement to pay taxes on these funds if such taxes are required. For example, if a single person elects to withhold $5000 for child care expenses and gets married to a non-working spouse, the $5000 would become taxable. If this person did not submit claims by the required date, the $5000 would be forfeited but taxes would still be owed on the amount.

Also, the annual contribution amount must remain the same throughout the year unless certain qualifying events occur, such as the birth of a child or death of a spouse.

ATX-101

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KYTHERA BIOPHARMACEUTICALS ANNOUNCES INITIATION OF

PHASE I/II CLINICAL TRIAL FOR LEAD PRODUCT CANDIDATE

LOS ANGELES, January 8, 2007 – Kythera Biopharmaceuticals, Inc. (“Kythera”)

announced today that it has commenced the Company’s first human clinical trial, a

Phase I/II study of ATX-101 for the reduction of localized fat deposits.

“This important milestone not only substantiates our belief in the potential of ATX-101,

but also validates our scientifically and medically rigorous approach to developing

prescription therapeutics in aesthetic and restorative dermatology,” said Keith Leonard,

Kythera’s President and CEO. “We hope ATX-101 will prove to be a new treatment

option for patients, and we are truly excited about the potential of ATX-101 in all

possible medical and aesthetic applications.”

ATX-101 is initially being investigated for the treatment of superficial lipomas, a type of

benign musculoskeletal fatty tumor that may occur in up to 2% of the population.

Lipomas are generally found on the torso, shoulder, arms and legs, and, while generally

asymptomatic, can cause local pain, tenderness or nerve compression. Individuals

seek to have their lipomas removed in order to reduce pain, for aesthetic reasons, or

both.

This ATX-101 clinical trial is being conducted in the United States and is intended to

identify the pharmacokinetics, safety and potential efficacy of ATX-101 in the treatment

of superficial lipomas. The Phase I/II randomized, double blind, placebo-controlled

study is the first of several planned trials to investigate the medical and aesthetic uses

of ATX-101. Kythera licensed the compound from Los Angeles Biomedical Institute at

Harbor-UCLA Medical Center.

“Until now, standard lipoma treatment has been surgical excision, which many patients

opt not to undergo due to the invasiveness and potential for scarring,” said Jay

Birnbaum, Kythera’s Chief Medical Officer. “We are hopeful that treatment with ATX-

101 can significantly reduce the size of, or eliminate, lipomas and thereby provide an

effective non-surgical, minimally invasive treatment option for patients.”

Evolence Discontinued

The economic downturn continues to particularly hurt "cosmoceutical" companies.  Evolence is the latest victim.  Ortho Dermatologics (a division of Ortho-McNeil-Janssen Pharmaceuticals, which is itself a division of Johnson & Johnson) has discontinued Evolence.

What is (was) Evolence?

• A soft-tissue filler based upon porcine collagen (from a pig)
• Excellent safety record:  Unlike bovine collagen (from a cow) which caused multiple allergies, Evolence was never associated with a single allergy.
• FDA approved on June 30, 2008:  The federal government was satisfied with its safety and efficacy.
• It has been used similarly to Juvederm and Restylane, especially at the nasolabial folds (connecting the nostrils to the corners of the mouth).
• Less swelling and bruising than Juvederm and Restylane
• Similar longevity as Juvederm and Restylane

If Evolence was similar to Juvederm and Restylane (and with less bruising), why wasn't it more popular?

Lumpiness.  A number of my patients noted that Evolence was not as soft or smooth at its competitors.  While the lumps were never visible, they were palpable (and apparently annoying).

My mother loved Evolence.  Women in their 60s and 70s have thinner skin, which tends to bruise significantly (with all of the injectable products).  When my mother had requested Juvederm, Restylane, Elevess/Hydrelle, or Radiesse, the subsequent bruising had persisted as long as two weeks.  However, with Evolence, the black-and-blue marks were smaller and resolved within a few days.

Evolence has filled a niche in my practice:  It is useful in patients who would like to minimize bruising...

• because they have a big event tonight!
• because they are older.
• because they naturally have thin blood.
• because they are on blood thinners (like Coumadin, Plavix, or aspirin).

What will be the new anti-bruising injectable filler?  In this economy, I don't know.  I certainly hope that Evolence is soon replaced.

Whatever Happened to LipoZap?

Bankrupt.

LipoZap went by many names:

• Lipostabil
• Flabjab
• Lipomelt
• Lipodissolve
• Fat-Away

All contained some quantity of phosphatidylcholine, a bile acid found naturally in our gall bladders.  German researchers recognized that intravenous phosphatidylcholine may prevent and treat blood vessel blockages caused by fat particles (known as fat emboli).  Other Europeans thought, "If it melts fat in the blood vessels, shouldn't it melt fat under the skin?"  The hope was that subcutaneous phosphotidylcholine injections would be a non-surgical alternative to liposuction.

However, LipoZap was never approved for cosmetic use (in any country).  Its efficacy was never proven.  And its safety was never established for subcutaneous injections.

Nevertheless, that didn't stop unscrupulous physicians from promoting and administering this product--even right here in the USA.

For $3000-5000, many patients underwent injections in their doctors' offices, in the hope that their stubborn fat deposits would melt away.  Their wishes almost uniformly went unanswered.  Most received no benefit.  Others developed irregularities.  Worst of all, a few patients suffered allergic reactions, hypersensitivities, and infections.

The satisfaction rate was abysmal.  Check out http://www.realself.com/LipoZap/reviews.  Zero out of 9 respondents would recommend LipoZap.

The unkindest cut of all:  The patients were swindled.  After the LipoZappers closed their doors, many patients were still owed money; they had not yet received all of the treatments paid for up front.  A number of class action lawsuits are pending.  I hope that the patients get their money back.

Did I Just Get Fake Botox?

The Plastic Surgery Group of Albany has pled guilty to misleading the public regarding fake Botox.  Apparently, five of the physicians in the practice admitted that they used "Tritox" on patients who were told that they were receiving injections of real Botox.

Tritox is a version of botulinum neurotoxin type A--just like Botox.  However, Tritox is not FDA approved.  On the contrary, it is not even approved for use on human beings!

Tritox, manufactured by Toxin Research International, Inc., in Tucson, Arizona, may be a good product.  I don't know; nobody does.  We are all still awaiting research documenting its efficacy and safety.

I suppose that the New York doctors purchased the Tritox in lieu of Botox because the price point was better.  However, those doctors should not have been so short sighted.  In addition to paying their legal fees, the surgical group now faces a fine of up to $500,000, and an order to pay restitution to 150 patients, who had forked over approximately $100,000 for treatments that they thought were for genuine Botox.

Also, the individual surgeons face up to one year in prison and fines of up to $100,000.  (Frankly, these guys got off light.  I am surprised that they are not going to lose their licenses.)

How can you avoid being duped?  Ask your plastic surgeon to show you the vial.  The label on authentic Botox Cosmetic is imprinted with an Allergan hologram.  (Allergan is the manufacturer of Botox.)

The only FDA-approved alternative to Botox is Dysport.  (Check out http://www.pickartplasticsurgeryblog.com/2009/05/ventura-patients-ask-botox-or-dysport.html.)  I really like Dysport--just like I love Botox.  Nevertheless, if you ask for Botox, and if you pay for Botox, that's what you should get.

Patient Dies in Florida After Liposuction...Performed by an Occupational Medicine Specialist

Awful stories of bad plastic surgery outcomes abound on the internet.  Unfortunately, there is a common theme:  The plastic surgery is often NOT performed by plastic surgeons.

Rohie Kah-Orukotan, who was herself a nurse, died after liposuction surgery on September 25, 2009, in Broward County, Florida.  The operation had been performed in a medical spa by Dr. Omar J. Brito Marin, an occupational medicine specialist, who had taken a three-day course on cosmetic surgery procedures.

This case nearly brings me to tears.  Not only is she an attractive young lady with a bright future, but the circumstances surrounding her death are unsafe and bizarre.

• Her physician is an occupational medicine specialist.
• • What the heck is that?!  I have been a physician for 13 years, and I don't even know what an occupational medicine specialist is.
  • Everyone should know what a real plastic surgeon is--a physician who has been certified by the American Board of Plastic Surgery. 
  • How could a nurse not know the difference? 
• He took a three-day course on cosmetic surgery.
• • I spent close to seven years in surgical training after four years of medical school. 
  • How could a nurse not know that a three-day course over a long weekend is not adequate?
  • Couldn't she have found a Board Certified Plastic Surgeon with years of training?
• The surgery was performed in a medical spa.
• • Liposuction is real surgery.  It should be performed in a real operating room!
  • Safety equipment and appropriate monitoring is essential to ensure good outcomes.
  • Board Certified Plastic Surgeon are required to use accredited facilities.  No occupational medicine specialist would even be let in the door to a certified facility.
  • How could a nurse not know that it is unsafe to have surgery in a spa where people usually just get massages?
• Apparently, the liposuction was performed with carboxytherapy, which supposedly reduces stretch marks and cellulite.
• • I have never even heard of carboxytherapy.
  • There is certainly NO scientific evidence that carboxytherapy reduces stretch marks and cellulite.
  • Carboxytherapy is NOT a standardized liposuction technique.
  • (For discussions of other liposuction gimmicks, check out http://www.pickartplasticsurgeryblog.com/2009/10/waterjet-assisted-liposuction-breakthrough-or-gimmick.html or http://www.pickartplasticsurgeryblog.com/2009/01/smartlipo-and-brazilian-butt-lifting-can-a-patient-use-the-smartlipo-fat-for-buttock-augmentation.html) 
  • How could a nurse fail to know that she was being duped with a gimmicky procedure?

This case teaches me that even professionals can be tricked.  If a nurse can be convinced to undergo gimmicky liposuction in the back room of a spa by a non-surgeon after he trained over a long-weekend, then the lay public is in deep trouble.

Family Doctors Performing Plastic Surgery?!

Sickening story from Las Vegas:

A woman won free breast augmentations from the doctor at the "Skin Body Institute," a local medi-spa.  She underwent surgery under local anesthesia but then suffered horrible complications. Some details from ABC 13...

• She was awake for the whole procedure, and was crying the entire time. The doctor reprimanded her for complaining during the painful procedure.
• (I never do breast augmentations under local anesthesia.  Patients should be put to sleep--by a Board Certified Anesthesiologist--so that they are comfortable.)
• Just weeks later, the implant became infected and was exposed through the skin.
• She subsequently underwent 10 hours of surgery under local anesthetic to try to fix the problem.
• Two weeks later she presented to the ER with ruptured and exposed implants.
• The doctor had made 10-centimeter incisions.
• (By the way, for routine breast augmentations, my incisions are typically 3-4 cm long for saline implants and 4-5 cm long for silicone).
• The doctor's website had stated he was board-certified.
• He was NOT certified by the American Board of Plastic Surgery, but by the Family Practice board.
• Still, his website listed him as an associate member of the American Academy of Cosmetic Surgery, the American Society of Laser Medicine and Surgery, American Society of Liposuction Surgery, and the American Society of Cosmetic Dermatology and Aesthetic Surgery.
• His medical license has been suspended.

This is another terrible incident where the patient did not do her homework and was the victim of a phony plastic surgeon.  Most patients do not understand that not all "Board Certifications" are legitimate. The American Board of Medical Specialties (ABMS) recognizes 24 "real" Boards. The only member Board that qualifies physicians to practice plastic surgery is the American Board of Plastic Surgery (ABPS).

This might seem obvious, but notice how confusing the situation can get. The offending family doctor also claimed certification by the American Board of Cosmetic Surgery (ABCS), etc., etc. The average person cannot know that the American Board of Cosmetic Surgery is not recognized by the American Board of Medical Specialties, and that in most states, the American Board of Cosmetic Surgery has no standing.  Simply stated, the American Board of Cosmetic Surgery is NOT a real board.

We doctors need to lead the charge on these issues.  However, these infractions are not on President Obama's radar screen.  Mr. President, in your forthcoming legislation, why not add commonsensical language preventing doctors from practicing outside of their formal training?  Otherwise, they really are just practicing.

Water-Jet Assisted Liposuction: Breakthrough or Gimmick?

More than in any other surgical technique, liposuction technology is marketed directly to consumers with little (to no) scientific evidence.  Some background...

• Standard suction assisted lipectomy employs a strong vacuum to remove stubborn fat deposits.
• Most surgeons add tumescent fluid to numb the surgical area and to constrict blood vessels (and thereby minimize bleeding).
• Power assisted liposuction involves a vibrating handle to minimize surgeon effort when removing the fat.
• Ultrasonic assisted liposuction uses ultrasonic energy to melt the fat before it is sucked out.
• Laser assisted liposuction uses a laser for melting fat before it is vacuumed out.
• Water-jet assisted liposuction supposedly limits intra-operative tissue distortion caused by the tumescent anesthetic fluid.

If all you knew about plastic surgery was learned from daytime television, then you would think that plastic surgeons perform liposuction...

• in their offices
• under local anesthesia--with tumescent fluid alone
• employing lasers to melt the fat
• water jets to minimize distortion

The truth is much less sexy.  The vast majority of Board Certified Plastic Surgeons prefer...

• an accredited surgical facility rather than the back room of their office
• heavy sedation--either "twilight sleep" or general anesthesia provided by an appropriately trained anesthetist
• some quantity of tumescent fluid for additional comfort and to decrease bleeding
• performing the actual liposuction with... standard techniques, power assisted devices, or ultrasonic machines

While I do like ultrasonic assisted liposuction (and I use the VASER system), as a Board Certified Plastic Surgeon, I have to admit that there are no good scientific studies documenting the superiority of ultrasound or laser-assisted liposuction relative to standard or power-assisted tumescent liposuction.

The water-jet is so new on the scene that there are exactly ZERO articles about it in the most prestigious plastic surgery publication Plastic & Reconstructive Surgery.  So, is water jet liposuction a breakthrough or gimmick?  I have absolutely no idea.

The best study on laser-assisted liposuction (from Chile, and published in Plastic & Reconstructive Surgery in 2006) demonstrated no major clinical differences between standard liposuction and laser assisted liposuction.  However, there were higher concentrations of free fat molecules floating in the blood of the laser patients, which alerts me to the possibility of potential damage to the liver, kidneys, or lungs.

So, truthfully, when patients ask me about laser and water-jet liposuction, I don't even know what to tell them.  In the past, I have mentioned the potential dangers of minimally tested technologies, and patients have actually become angry at me for my skepticism!  It's amazing to me that my caution turns people off.  Typically, patients express disbelief that lasers or water could be anything but positive.

The effects of marketing can obviously be pernicious.  It's incredible that the makers of these product have been able to convince the public of their products' efficacies before they have even convinced the surgical community!  Crazy!!