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.

Dr. Pickart To Host More Training Sessions for Sculptra Aesthetic

Dr. Pickart is the only Board Certified Plastic Surgeon in Southern California who trains other physicians on the appropriate techniques for Sculptra Aesthetic.  He has recently returned from...

• Denver, Colorado
• Lawrence, Kansas
• Oklahoma City, Oklahoma
• Houston, Texas
• Galveston, Texas
• Burbank, California

He will be hosting additional training sessions for physicians in...

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.”

No Insurance Company Will Pay for a Tummy Tuck

I have a PPO.  How can I get my insurance company to pay for a tummy tuck?  Or will I have to pay for it out of pocket?

-Andy in Ventura, California

Dear Andy,

I think that you are confusing 2 separate procedures:

• panniculectomy
• abdominoplasty

A panniculectomy is a functional procedure for removing excess skin and fat.  An insurance company MAY authorize a panniculectomy if...

• The apron of excess abdominal skin impedes walking.
• The apron of excess abdominal skin impedes normal groin hygiene.
• There are recalcitrant fungal infections beneath the skin folds.
• The fungal infections have progressed to bacterial infections, necessitating hospitalization and IV antibiotics.

A panniculectomy is NOT an attractive operation.  The goal is function, not cosmesis.

• There is no tailoring of the skin excess.
• There is no liposuction to contour the flanks.
• The bellybutton is not preserved.
• The muscles are not tightened.
• The abdomen is not optimally flattened.

If your goals are functional, then you should consider a panniculectomy.  Find a Board Certified Plastic Surgeon who accepts your insurance, and then speak with him/her frankly.

If, however, your goals are to have a more attractive torso, then you are looking for an abdominoplasty, better known as a tummy tuck.  An abdominoplasty will take care of everything that a panniculectomy will, but it will also do more....

• The extra skin and fat (that creates the "apron" and/or the "roll") will be removed.
• The skin will be pulled taut, and will be tailored to your frame.
• The bellybutton is reconstructed and rejuvenated.
• The "six-pack" muscles are tightened.
• The abdomen is flattened.
• Often, some liposuction is done on the flanks to optimize the waist.

Obviously, no insurance company is going to pay for you to look cuter.  Medical insurance is supposed to help defray medical expenses.  An unattractive belly is not a medical problem; it is an aesthetic issue.  So, an abdominoplasty would be your financial responsibility.

There is one more caveat:  Sometimes, a patient suffers medical problems from an abdominal "apron."  Moreover, he/she wants not only functional relief but also aesthetic improvement.  In this circumstance, the surgeon can help the patient obtain authorization for a panniculectomy.  The patient might then pay the difference for a full tummy tuck.  In effect, the patient is getting the best of both worlds:  functional improvement (covered by the insurance company) and cosmetic enhancement.  Check out this example below...

 

Breast Implants: Consideration #9: Complications

Are you willing to accept potential complications

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poor scarring, bleeding, infection, malposition, asymmetry, capsular contracture, finite life span of implants, wrong size

Breast Implants: Consideration #8: Adjunctive Procedures? Lift Up? Lipo?

Adjunctive procedures

lipo of the anterior axilla or armpits or water wings

lift up

change shape, such as for constricted breasts

Breast Implants: Consideration #7: Size

not to exceed your body's frame

not to exceed your skin's elasticity

enough to fill the envelope

err on the bigger side

Volumes to go up by a size

32 250

34 300

36 350

38 400

40 ?

Gel is smaller than saline by 8%; go for bigger for gel

 

short, medium, or high profile

Breast Implants: Consideration #6: Position of Implants - Above or Below Muscle

 

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• Subglandular implant:  The prosthesis is placed under the breast tissue but on top of the pectoralis major muscle.
• Subpectoral implant (or submuscular implant):  The prosthesis is placed behind the pectoralis major muscle (which is itself behind the breast gland).

Obviously, Holly, you deserve a customized evaluation, and only then can a Board Certified Plastic Surgeon help you make the best decision.  Nevertheless, there are some general advantages and disadvantages of the two options....

Subglandular Implants

Advantages:

• Technically easier operation for the surgeon
• Can be placed without general anesthesia (without going totally to sleep)
• Larger implants can be accomodated
• Potentially, more cleavage can be created
• No surgery on the muscle; therefore, less discomfort
• No surgery on the muscle; therefore, faster recovery time
• More "lift" effect, so that formal breast up-lift operations can be avoided

Disadvantages

• The "look" tends to be more artificial and less natural
• More rippling
• Greater likelihood of capsular contracture
• More difficult to interpret mammograms

Subpectoral Implants

Advantages

• Usually, a more natural breast appearance
• Less rippling
• Lower risk of capsular contracture
• More successful mammogram readings

Disadvantages

• More difficult operation
• Requires general anesthesia
• Can not always produce as much cleavage as the patient might desire
• More discomfort
• Longer recovery time
• Among women with large pectoralis majors, muscle contraction can distort the implant

Practically speaking, I try to convince most of my patients here in Ventura, California (>90%) to undergo subpectoral placements.  The unusual exceptions...

• Extreme fear of general anesthesia
• Very low pain tolerance
• Looking for a "fake" look
• High performance athletes, whose pectoralis major muscles should not be altered
• Body builders, in whom muscle flexion would distort their breasts during competitions
• Male-to-female transsexuals, whose large XY pectoralis major muscles would not accomodate a subpectoral implant

I like saline implants above the muscle when the patient...

• ...already has a fair amount of breast tissue.
  • Saline implants tend to ripple more than silicone.
  • Hence, those implants need some sort of coverage to camouflage that rippling.
  • That coverage can come from the muscle or from breast tissue.
  • If a woman's breasts are already big, but she would like them even bigger, placing implants on top of the muscle is usually OK.
• ...wants the most natural results when she exercises (nearly) naked(!)
  • The breasts are naturally on top of the muscles.
  • Therefore, if the muscles move, the overlying breasts shouldn't move that much.
  • However, if the implants are beneath the muscles, the breasts might move unnaturally when the muscles contract.
  • Since most women don't exercise naked, this is a minor issue for most patients.
  • Nevertheless, some women do compete in sports in small bikinis, and they are aware of breast distortions with shoulder/chest muscle contractions (such as beach volleyball players, surfers, body builders...see below)
• ...is a body builder.
  • Body builders have very well developed muscles.
  • Contraction of those big muscles would significantly distort the positions of sub-muscular implants.
  • These women do pose nearly naked (in small bikinis) while flexing their muscles.
  • Even though these women do not have a lot of body fat, implants on top of the muscle are generally better.
  • In competitions, the rippling of the implants looks less bad than implant distortion.
• ...has droopy breasts and prefers to avoid formal lift-up procedures
  • Implants themselves provide breast rejuvenation.
  • The muscles tend to mute the rejuvenative/lift-up effects of breast augmentations.
  • Even though many women need mastopexies (lift-up surgeries) at the same time as their augmentations, some patients prefer to avoid the additional scars of mastopexies and accept the limitations of implants on top of the muscles.
• ...is looking for a quicker recovery
  • Most breast implants surgeries do not require a long recovery.
  • However, positioning of the implants below the muscle is more uncomfortable.
  • Staying on top of the muscle is much less painful.

Generally, I use silicone implants when patients choose to have their augmentations on top of the muscle.  Or, better yet, I place implants beneath the muscle in 90% of circumstances...

• to minimize rippling
• to reduce excess scar tissue around the implants (known as capsular contracture)

• Subglandular implant:  The prosthesis is placed under the breast tissue but on top of the pectoralis major muscle.
• Subpectoral implant (or submuscular implant):  The prosthesis is placed behind the pectoralis major muscle (which is itself behind the breast gland).

Obviously, Holly, you deserve a customized evaluation, and only then can a Board Certified Plastic Surgeon help you make the best decision.  Nevertheless, there are some general advantages and disadvantages of the two options....

Subglandular Implants

Advantages:

• Technically easier operation for the surgeon
• Can be placed without general anesthesia (without going totally to sleep)
• Larger implants can be accomodated
• Potentially, more cleavage can be created
• No surgery on the muscle; therefore, less discomfort
• No surgery on the muscle; therefore, faster recovery time
• More "lift" effect, so that formal breast up-lift operations can be avoided

Disadvantages

• The "look" tends to be more artificial and less natural
• More rippling
• Greater likelihood of capsular contracture
• More difficult to interpret mammograms

Subpectoral Implants

Advantages

• Usually, a more natural breast appearance
• Less rippling
• Lower risk of capsular contracture
• More successful mammogram readings

Disadvantages

• More difficult operation
• Requires general anesthesia
• Can not always produce as much cleavage as the patient might desire
• More discomfort
• Longer recovery time
• Among women with large pectoralis majors, muscle contraction can distort the implant

Practically speaking, I try to convince most of my patients here in Ventura, California (>90%) to undergo subpectoral placements.  The unusual exceptions...

• Extreme fear of general anesthesia
• Very low pain tolerance
• Looking for a "fake" look
• High performance athletes, whose pectoralis major muscles should not be altered
• Body builders, in whom muscle flexion would distort their breasts during competitions
• Male-to-female transsexuals, whose large XY pectoralis major muscles would not accomodate a subpectoral implant