Wilfred Brown, MD, FACS: Plastic Surgeon In Connecticut & New York

Dr. Wilfred Brown has a medical spa and plastic surgery practice in Middlebury, Connecticut and belongs to New York Aesthetic Consultants, a group practice in Manhattan's Upper East Side.

Splitting time between two practices in different states poses some challenges.

Name: Dr. Wilfred Brown
Location: Middlebury. CT and New York, NY
Website: thenyac.com; drwilfredbrown.com

That's Interesting: Dr. Brown completed his medical training at the University of Witwatersrand in Johannesburg, South Africa then six years of General Surgery training through Yale University, followed by a fellowship in Plastic and Reconstructive Surgery and Pennsylvania State University.

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Warren Seiler MD, A Laser Center & Medical Spa In Alabama

Dr. Seiler is a speaker, preceptor and physician trainer for Lumenis Laser Company and injection trainer for Allergan (manufacturer of Botox & Juvederm).

Birmingham Alabama is home to Seiler Skin, Cosmetic Laser Center & Medical Spa, a single-physician clinic run by Dr. Warren Seiler and his wife. We sat down with Dr. Seiler to find out what he thinks of the current crop of cosmetic lasers, how he runs his clinic, and hear what advice he has for other physcians.

Name: Dr. Warren B. Seiler III
Location: Homewood, AL
Website: seilerskin.com

That's interesting: Dr. Seiler is a Board Examiner and the Executive Director of the American Board of Laser Surgery and co-author of the ABLS examination text book and board certification exam.

As a single physician owner, how does your clinic operate?

My practice, Seiler Skin Cosmetic Laser Center, is a single physician driven cosmetic practice. I personally perform the laser and injectable procedures. I have a very good medical aesthetician working directly under me who helps patients with skincare programs, Hydrafacial, chemical peels, and laser hair removal. My wife is our marketing and website director and she is co-owner with me in the practice. We run the practice together, but we have an office manager that helps.  I perform fractional CO2, Fraxel, Thermage, Laser Hair Removal, Laser Spider Vein treatments, IPL, and others. Botox and Juvederm are the only injectables, although I have tried many others, I feel they are the best. Our practice is really the only one in Birmingham in which the physician specializes entirely in cosmetic laser procedures and nothing else, which really helps to offer the experience that I provide.  

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Dr. Shervin Naderi, Rhinoplasty, Botox, & Injectables In Virginia & Maryland

Shervin Naderi MD focuses on Rhinoplasy and injectibles at the Naderi Center for Rhinoplasyt & Cosmetic Surgery in Herndon, Virginia and Chevy Chase, Maryland.

With his emphasis on Rhinoplasty, Botox, Dysport and filler injections, Dr. Maderi has other plastic surgeons referring patients to his clinics in Virginia and Maryland. We thought we should sit down and learn from Dr. Naderi what he thinks about running a cosmetic practice.

Name: Shervin Naderi, MD, FACS
Location: Herndon, VA and Chevy Chase, MD
Website: VirginiaFacialPlasticSurgery.com

That's interesting: Dr. Shervin Naderi is Board Certified Facial Plastic & Reconstructive Surgeon and ultra specialized in Rhinoplasty and minimally invasive facial injections.  Hes' also a Board Examiner for the American Board of Facial Plastics & Reconstructive Surgery and a consultant and instructor for Allergan and Medicis, teaching Botox, Dysport and facial dermal filler injections to other physicians and nurse injectors.

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Interview: Lila Bratani MD, Plastic Surgeon In Germany

AA look at plastic surgery in Germany with Dr. Lila Bratani.

Physician:  Dr. Lila Bratani
Location: Karlsruhe, Germany
Website: www.drbratani.com, http://www.estheticon.de/chirurgen/dr-lila-bratani

That's interesting: Dr. Lila Bratani is recognized as a member of Stanford's Who's Who for having demonstrated outstanding leadership and achievement in her field.

How did your cosmetic medicine training kick off?

Back when I was a teenager, I was attracted to aesthetic medicine and of course beauty and anti-aging. My first step in Plastic Surgery was when I got a good training by my teacher, Prof. Muehlbauer, one of the leading aesthetic surgeons in Germany and recognized worldwide. I also completed a fellowship in advanced aesthetic medicine and got trained in cadaver courses in Brazil (Sao Paulo and in Brasilia). I was working with great colleagues and I am still learning a lot of new techniques in the aesthetic medicine field. The art of this profession gives the ultimate satisfaction.

Can you tell us more about your surgical clinic and how it's organized?

I’m the chief of the Plastic and Aesthetic Department in a private clinic. The owners are dermatologists and it works perfectly. We offer plastic surgery, hand surgery as well as non invasive treatments such as laser. We also have 3 cosmeticians in our skin cosmetic center. The clinic consists of: 1 plastic surgeon (me), 6 dermatologists, 3 cosmeticians, 1 practice manager, 1 PR and clinic manager, 1 OR nurse, 3 frontdesk assistants and 8 physician assistants. We serve to a mix of private and state health care patients.

The requirements for hiring staff in our plastic and aesthetic surgery clinic are very high. PA’s and nurses have to understand that they need to have this extra “service” for extraordinary plastic surgery patients. We like them to have a corporate identity that represents our clinic well and of course a fabulous attitude and behavior.

We use commission on the cosmetic sales.

What laser technologies are you using? What are your thoughts about the technologies you’re using now?

We don’t use IPL, but we are using Alexandrite, Ruby, NdYag laser and Fraxel, CO2-Laser. I like most of the Fraxel  and new devices of Radiofrequency (Thermage and BodyTite). I have a lot of experience on the smooth liposuction with radiofrequency using the BodyTite device and so far, I'm seeing great results with skin tightening.

Where do you spend money on advertising? What works best for your practice?

We have websites, social media as Facebook, publications on newspapers and  journals such as Vogue. We also distribute e-newsletters for existing patients via email. In the waiting rooms, we showcase programs with different techniques of aesthetic procedures. This kind of advertising works much better than handing out external flyers or ads. 

(Sponsored: See Frontdesk waiting room videos for plastic surgeons and dermatologists.)

What are the in demand treatments in your clinic? Are you planning to add something new?

All kind of aesthetic surgery procedures like breast augmentation, facelifts, liposuction and face skin rejuvenation with radiofrequency as well the small procedures as fillers such as Botulinum toxin therapy.  I will be adding more fat grafting and liposculpturing techniques soon.

What have you learned about practicing cosmetic medicine? What stories can you tell?

I have learned to offer what I think is good for the patients and not to please the unrealistic demands of someone. Sometimes patients bring their own drawings of unrealistic body parts. I’m aware of dysmorphophobic patients and refuse to do anything on those. 

What advice would you give to other physicians based upon your experiences?

Working hand in hand with other colleagues is a benefit for starting into aesthetic medicine. You may share the cosmetic lasers and IPLs (which are very expensive) when starting your own clinic. Never underestimate the non-invasive procedures, even we plastic surgeons love it than being in the operating room with the scalpel in the hand.  Set your own “branding” so that patients will be pleased with your work and aura and will bring you more patients via word of mouth, which is also a great marketing tool.

About: Dr. Lila Bratani completed her Craniofacial and Plastic Surgery fellowship in Nova Southeastern University. With over 10 years of experience in Plastic, Aesthetic, Reconstructive, Laser and Hand Surgery, she is a university lecturer, medical manager and an esteemed health care consultant in New York,USA. She specializes in burn surgery and tissue engineering. Other than that, she is an active member of the Society of Plastic Surgeons of Germany DGPRAEC, WOSAAM (World Society of Anti Aging Medicine), IPRAS (International Society of Plastic Reconstructive and Aesthetic Surgeons) and DGBT (German Society for Aesthetic Botulinum Toxin Therapy.

This interview is part of a series of interviews of physicians running medical spas, laser clinics and cosmetic surgery centers. If you'd like to be interviewed, just contact us.

Thermage Repetitive Motion Lawsuit

Thermage has been sued by a Dr. Supriya Goyal Bellew on for negligence, strict products liability, and breach of implied warranties.

To be honest this looks somewhat bogus, with a physician claiming that the design of the Thermage handpeice caused recurring pain and that Thermage was negligent. You'll want to read the entire finding though. It's interesting stuff; especially the findings that preclude summary judgement.

GOYAL v. THERMAGE, INC.

SUPRIYA GOYAL, Plaintiff,
v.
THERMAGE, INC., Defendant.

Civil No. WDQ-08-0020.

United States District Court, D. Maryland, Northern Division.

July 1, 2010.

MEMORANDUM OPINION

WILLIAM D. QUARLES Jr., District Judge.

Dr. Supriya Goyal Bellew^{[ 1 ]} sued Thermage, Inc. ("Thermage") for negligence, strict products liability, and breach of implied warranties. For the following reasons, Thermage's motion for summary judgment will be granted in part and denied in part, and Bellew's motion to strike will be denied.

I. Background^{[ 2 ]}

On September 1, 2004, Bellew began working at the Maryland Laser, Skin, and Vein Institute ("MLSVI") as a cosmetic dermatology research fellow. Bellew Dep. 90:17-91:3. Within her first month at MLSVI, Bellew began treating patients using the ThermaCool device developed by Thermage to reduce the signs of aging in skin. Id. 124:3-16.^{[ 3 ]} Dr. Robert Weiss^{[ 4 ]} and his wife Dr. Margaret Weiss—both physicians at MLSVI—taught Bellew how to use the device. Id. 130:9-10; Margaret Weiss Dep. 174:2-8.^{[ 5 ]}

The ThermaCool device has a handheld component (the "ThermaCool handpiece"), which the operator holds to the patient's skin while pressing a manual button or a foot pedal to deliver radio frequency pulses. Pl.'s Dep. 111:8-112:5, 135:4-7. After instructing Bellew on its proper use, Robert Weiss observed her using the ThermaCool handpiece and told her that she "was doing everything properly and appropriately and delivering treatments the way that they were supposed to be done." Id. 131:21-132:6. The design of the handpiece required Bellew to hold her wrist and arm "in a bent, flexed position at a very odd angle for the entire treatment," id. 112:7-10,^{[ 6 ]} and several physicians at MLSVI, including Bellew and Robert Weiss, commented that the device was "awkward" to use, id. 134:9-20.

In October or November 2004,^{[ 7 ]} Bellew began to have soreness and pain, which she associated with her use of the ThermaCool device. Id. 208:13-20. At first, she experienced temporary soreness in her right hand, arm, shoulder, and neck, but her symptoms progressed to intermittent "shooting pain" and "clawing up of [her] ring and pinky fingers" for up to a few days after she performed a Thermage treatment. Id. 206:14-21, 208:13-20. Bellew mentioned these symptoms to the Weisses, who told her that they experienced similar pain and that it was "normal and not anything unusual." Id. 152:16-21. Upon the Weisses' advice, Bellew took over-the-counter pain medications and rested her arm, which completely relieved her symptoms. Id. 151:17-20, 153:8-11. Because the pain was transient and manageable with Advil, Bellew attributed her discomfort to use of new muscle groups that she had not previously used and "did [not] really worry about it." Id. 151:3-20.

On January 4, 2005, Bellew delivered almost 1200 pulses during two Thermage treatments, id. 170:6-8, 209:3-5, and developed pain that was different and more severe than her previous pains, id. 213:18-214:4.^{[ 8 ]} That evening, Bellew wrote to the Weisses to explain that she had "shooting pains and muscle spasms in [her] right hand and wrist," which she attributed to the ThermaCool handpiece. Def.'s Ex. 7 (Jan. 4, 2005 e-mail from Bellew).^{[ 9 ]} On January 5, 2005, Bellew wrote again to say that she was "concerned about nerve damage," planned to schedule an orthopedics appointment, and would not be able to perform Thermage treatments until her hand had healed. Def.'s Ex. 6.^{[ 10 ]}

On January 18, 2005, Dr. Thomas Brushart diagnosed Bellew with "irritation [of her] right ulnar nerve secondary to repetitive motion," which "appear[ed] directly related to her use of the Thermage machine." Pl.'s Ex. 8 at GOYAL:JHH:0010. Although Bellew never again used the Thermage device, her ulnar neuropathy and a resulting chronic pain syndrome have persisted. Pl.'s Dep. 51:13-20, 52:8-17, 209:15-16.

On January 2, 2008, Bellew sued Thermage for negligence, strict products liability, and breach of the implied warranties of merchantability and fitness for its ordinary purpose. Paper No. 1. On March 20, 2008, Thermage moved to dismiss the breach of warranty claims, Paper No. 5, and answered the other claims, Paper No. 6. On June 5, 2008, Judge Andre M. Davis denied the motion to dismiss and ordered Thermage to file an amended answer by June 19, 2008. Paper No. 12.^{[ 11 ]} On October 31, 2008, Judge Davis granted Thermage's motion to amend its answer to include several new affirmative defenses. Paper No. 32. On November 18, 2009, Thermage moved for summary judgment. Paper No. 55. On February 23, 2010, Bellew moved to strike the statute of limitations defense to the implied warranty claims from the motion for summary judgment. Paper No. 66.

II. Analysis

A. Standard of Review

Under Rule 56(c), summary judgment "should be rendered if the pleadings, the discovery and disclosure materials on file, and any affidavits show that there is no genuine dispute as to any material fact and that the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(c). In considering a motion for summary judgment, "the judge's function is not . . . to weigh the evidence and determine the truth of the matter but to determine whether there is a genuine issue for trial." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249 (1986). A dispute about a material fact is genuine "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Id. at 248. The Court must "view the evidence in the light most favorable to . . . the nonmovant, and draw all reasonable inferences in h[is] favor," Dennis v. Columbia Colleton Med. Ctr., Inc., 290 F.3d 639, 645 (4th Cir. 2002), but the Court also "must abide by the affirmative obligation of the trial judge to prevent factually unsupported claims and defenses from proceeding to trial," Bouchat v. Baltimore Ravens Football Club, Inc., 346 F.3d 514, 526 (4th Cir. 2003).

B. Statute of Limitations for Breach of Warranty Claims

Thermage argues that Bellew's breach of warranty claims are barred by the four-year statute of limitations. Def.'s Summ. J. Mot. 10-11. Bellew moved to strike this affirmative defense from the motion for summary judgment, arguing that Thermage waived this defense by not timely raising it. Paper No. 66 at 6-12.^{[ 12 ]}

Generally, a defendant waives the statute of limitations by failing to raise that defense in its answer or a pre-answer motion. See Fed. R. Civ. P. 8(c) & 12(b); Erline Co. S.A. v. Johnson, 440 F.3d 648, 653-54 (4th Cir. 2006). However, the court will "freely give leave" to amend pleadings "when justice so requires." Fed. R. Civ. P. 15(a)(2). The Court previously considered and rejected Bellew's argument that Thermage waived the statute of limitations defense by failing to raise it in the original answer and allowed amendment of the answer to include that defense. See Paper No. 28 at 13-14; Paper No. 32. Because Thermage asserted the statutes of limitations as an affirmative defense in its amended answer, see Paper No. 24, Ex. 2 at 10,^{[ 13 ]} that defense was not waived and may be raised on summary judgment. Accordingly, her motion to strike the breach of implied warranties claims will be denied.

Under Maryland law, "[a]n action for breach of any contract for sale must be commenced within four years after the cause of action has accrued." Md. Code Ann., Com. Law § 2-725(1). Generally, a cause of action for breach of warranty accrues "when tender of delivery is made." Id. § 2-725(2). But if "a warranty explicitly extends to future performance of the goods and discovery of the breach must await the time of such performance [then] the cause of action accrues when the breach is or should have been discovered." Id.

Here, no explicit warranty extended the implied warranties to future performance of the Thermage device. Thus, a timely filing would have required Bellew to have been injured by a device delivered between January 2, 2004^{[ 14 ]} and January 4, 2005.^{[ 15 ]} Shipment records indicate that Thermage delivered a ThermaCool system to MLSVI in 2002; no Therma-Cool system handpieces were delivered to Dr. Robert Weiss or MLSVI from January 1, 2004 to January 5, 2005. Julie Hill Aff. ¶¶ 3-6, Nov. 16, 2009. Because Bellew did not bring her breach of warranty claims within four years of the ThermaCool handpiece's delivery, those claims are barred by the statute of limitations.

C. Statute of Limitations for Tort Claims

Thermage argues that Bellew's tort claims are barred by the three-year statute of limitations. Def.'s Mot. Summ. J. 11-18. Bellew argues that this issue cannot be decided on summary judgment because there is a question of fact about when the limitations period began. Pl.'s Summ. J. Opp. 8-33.

Under Maryland law, "[a] civil action at law shall be filed within three years from the date it accrues" unless otherwise provided by another Code provision. Md. Code Ann., Cts. & Jud. Proc. § 5-101.^{[ 16 ]} To determine when a cause of action "accrues," Maryland follows the "discovery rule," which starts the limitations period when the plaintiff had notice of a claim. Pennwalt Corp. v. Nasios, 314 Md. 433, 550 A.2d 1155, 1165 (Md. 1988). Notice requires actual knowledge, either express or implied, of the facts underlying the cause of action. Id. at 1160, 1165-66.^{[ 17 ]} Accordingly, in a products liability tort action, "the statute of limitations [does] not begin to run until the plaintiff knows or through the exercise of due diligence should know of injury, its probable cause, and either manufacturer wrongdoing or product defect." Id.

"[T]he party raising a statute of limitations defense has the burden of proving that the cause of action accrued prior to the statutory time limit for filing the suit." Newell v. Richards, 323 Md. 717, 594 A.2d 1152, 1156 (Md. 1991). To show that a plaintiff was on inquiry notice of her potential claim, the defendant must prove that "(1) the plaintiff[] knew of facts sufficient to cause a reasonable person to investigate further, and (2) a diligent investigation would have revealed that the plaintiff[]" suffered injury probably caused by the defendant's wrongdoing. Pennwalt, 550 A.2d at 1163-64; Quillin v. C.B. Fleet Holding Co., No. CCB-07-00503, 2007 WL 3103903, at *3 (D. Md. Oct. 11, 2007). "[Q]uestions of fact on which a limitations defense will turn are to be decided by the jury or, when sitting as a jury, by the court." O'Hara v. Kovens, 305 Md. 280, 503 A.2d 1313, 1323 (Md. 1986).^{[ 18 ]}

Because Bellew filed this suit on January 2, 2008, her tort claims must have accrued on or after January 2, 2005 to be within the limitations period. The parties dispute when Bellew knew or should have known that she was injured and had a potential claim against Thermage.

Bellew argues that she was not on notice of her injury until January 4, 2005. In support of that position, she has produced an affidavit and deposition from one of her treating neurologists at Johns Hopkins, Dr. Beth Murinson. See Pl.'s Ex. 2 & 3. In her deposition, Murinson explained that neuropathic nerve injury can be difficult to diagnose and requires a "correlation of medical history with . . . diagnostic testing." Beth Murinson Dep. 113:9-13, 115:5-17, Jan. 13, 2010.^{[ 19 ]} Murinson has testified that the symptoms Bellew experienced in 2004 may have "indicat[ed] that [her] ulnar nerve was being temporarily compressed" but that such "[m]inor temporary compression of the ulnar nerve does not ordinarily result in clinically significant injury to the nerve." Beth Murinson Aff. ¶ 7, Jan. 13, 2010. She further explained that "[t]here is no medical evidence . . . to prove . . . with certainty, that [Bellew] suffered a clinically significant, permanent injury during the initial period of months when she first used the Thermage device." Id. ¶ 7; Murinson Dep. 200:21-202:17, 205:2-14. By contrast, the severe and unabating pain that Bellew experienced on and after January 4, 2005, was indicative of a "clinically significant injury." Murinson Aff. ¶ 8; Murinson Dep. 111:16-113:6.

Consistent with Murinson's testimony, Bellew stated that, until January 4, 2005, she attributed her symptoms to normal pain associated with exercising new muscle groups. Her conversations with Thermage-experienced physicians, the transient nature of her symptoms, and her ability to gain relief using over-the-counter pain medications further reinforced her belief that the pain was "normal" and nothing to worry about. Although she may have known that the Thermage device was "conducive to developing a repetitive use injury" before January 4, 2005, Bellew did not suspect that she had suffered such an injury until that date.

Given this evidence, a reasonable jury could conclude that Bellew did not have notice of her injury until after January 2, 2005; accordingly, summary judgment must be denied.

D. Assumption of the Risk

Thermage argues that Bellew assumed the risk of injury because she recognized that the ThermaCool handpiece might cause a repetitive use injury and experienced symptoms of such an injury but continued to use the device until January 4, 2005. Def.'s Summ. J. Mot. 18-19.

To establish the assumption of the risk defense in a products liability action, the defendant must show that the plaintiff (1) knew of and appreciated the risk of danger, (2) voluntarily confronted that risk, and (3) was unreasonable in her decision to encounter the known risk. Ellsworth v. Sherne Lingerie, Inc., 303 Md. 581, 495 A.2d 348, 356 (Md. 1984).^{[ 20 ]} The test of whether the plaintiff knew of, appreciated, and voluntarily confronted "the risk involved in a particular situation is an objective one . . . and ordinarily is a question to be resolved by the jury." Morgan State Univ. v. Walker, 397 Md. 509, 919 A.2d 21, 24, 26-27 (Md. 2007)(internal citations omitted). But, "when it is clear that a person of normal intelligence in the position of the plaintiff must have understood the danger, the issue is for the court." Schroyer v. McNeal, 323 Md. 275, 592 A.2d 1119, 1123 (Md. 1991).^{[ 21 ]} If established, assumption of the risk is "a complete bar to recovery because `it is a previous abandonment of the right to complain if an accident occurs.'" ADM P'ship, 702 A.2d at 734 (quoting Warner v. Markoe, 171 Md. 351, 189 A. 260, 264 (Md. 1937)).

Here, the parties dispute, inter alia, whether Bellew appreciated the risk of danger and was unreasonable in her choice to continue delivering Thermage treatments until January 4, 2005. To support her argument that she did not fully appreciate the risk, Bellew has offered evidence that she (1) had limited experience with Thermage prior to her fellowship at MLSVI, (2) relied on the Weisses' assurance that her pains were "normal," (3) associated her symptoms in 2004 with new muscle use, and (4) used the device for only a few months before her injury occurred. Bellew also argues that, even if she appreciated the risk of danger, she has shown that her choice to continue delivering Thermage was reasonable because the Weisses had experienced similar pain without long-lasting injury and over-the-counter pain medication alleviated her pain entirely. Because a reasonable jury could find that Bellew did not assume the risk of her injury, summary judgment based on this defense must be denied.

III. Conclusion

For the reasons stated above, Thermage's motion for summary judgment will be granted as to the claims for breach of implied warranty and denied as to the negligence and strict liability claims.

The Thermage sumary judgement is here

Solta illumiNATION Tour: Thermage & Fraxel

Solta is taking it's show on the road with the illumiNATION tour. (Perhaps the Illuminati for Fraxel & Thermage?)

You can see if it's passed you by yet or you still have a shot at getting some finger food and a demo.

You can see the site detailing the tour here.

Looking for used Thermage tips?

I had thought that the reactivated or used Thermage tips had been exterminated by Theremage, but I guess not. I've received three emails this week asking for contact information for the gray market providers.

New Thermage web site design.

Solta Medical, the parent company of Thermage and now Fraxel, has a new and somewhat suprising look for the new Thermage web site.

I like it if only for trying something new and getting away from the bordom that pervades the typical corporate technology site.

Thermage changes its name to Solta Medical

Thermage Inc., has changed its name to Solta Medical Inc. and unveiled a new logo, along with a new logo and website for the Thermage product.

Theremage the company bought Reliant Technologies, maker of the laser resurfacing device Fraxel, for $87.5 million in a cash and stock deal last year. The new ticker symbol will be "SLTM" and is listed on the Nasdaq.

The design of the new Thermage site a fine change from the stagnant templates that most of the IPL and laser companies use. We'll have to see how it works for them.

From the Solta press release:

Thermage, Inc. (NASDAQ: THRM) announced that effective today it has changed its corporate name to Solta Medical, Inc. At the open of the NASDAQ exchange this morning, Solta Medical, Inc. will begin trading under the symbol “SLTM.”

"The name and ticker symbol changes are a great start to the New Year and a key milestone in the integration of the acquisition of Reliant Technologies, Inc. The new company combines the industry’s two leading brands, Thermage® and Fraxel®, under a new corporate name that will now form a global leader in aesthetic energy devices,” said Stephen J. Fanning, chairman of the board, president and CEO. “Solta Medical will focus on providing superior anti-aging solutions for patients and physicians by offering the gold standard of care for tightening, contouring and resurfacing of the skin with Thermage and Fraxel treatments.”

Solta Medical also announced the expansion of its industry-exclusive customer loyalty program which allows physicians to lock-in preferred pricing for Thermage and Fraxel treatment tips along with other preferred customer benefits to help physicians grow their practices and increase practice profitability.

“Thermage and Fraxel are the strongest aesthetic device brands available to physicians today,” said Suzanne Bruce, MD, dermatologist and president of Suzanne Bruce and Associates in Houston, Texas. “By combining these two brands into one company and expanding the customer loyalty program, Solta Medical is opening a number of new opportunities for doctors to conveniently and cost-effectively access a full suite of safe and effective anti-aging solutions.”

Thermage Lips: Plump yer pucker.

'Thermage Introduces Lips by Thermage, a New Non-Invasive Aesthetic Procedure for Lips  Offering consumers fuller, more defined looking lips without injections'

 

Plasticized says: "This new marketing tool for a now commonly found machine in aesthetic offices uses a small tip to tighten the skin around the lips, minimizing lines. It may also promote fuller lips by stimulating collagen formation.

Still, we are skeptical. The procedure is costly due to the extremely expensive, disposable tips that must be bought from the same company.

This could be an appropiate time to invoke the adage, "To a hammer, the world is a nail". 

Reactivated Thermage Tips: Thermage responds to supposed study.

Thermage's response to physicians purchasing reactivated tips from abroad.

 
Clint Carnell, VP of Thermage, asked me to post Thermages position on reactivating tips. I have posted it in it's entirety and have added an addendum to the previous post on the supposed study in question.

You'll notice that Clint asks me to remove the post to that study. I've exchanged a number of emails with Clint and he's agreed that the best course of action for Thermage to take will be to have this connected to reactivation post. The study in question is posted a number of times on the web and since this site is likely the first stop, it's also Thermages best option to position a counterpoint where someone searching for reactivated Thermage tips will be exposed to Thermage's position and opinion.

Thermage's position on the supposed study for reactivating Thermage tips: 

I am Vice President of Domestic Sales for Thermage, Inc. 

On your Medical Spa MD web page your blog entitled “Study: Safety & Performance of Reactivated Thermage Thermacool Tips,” gives a summary of a study which allegedly investigated the safety and performance of reactivated Thermage treatment tips, as well as a link to the study publication.  The publication claims Thermage treatment tips can safely withstand 50,000 shots.   

  We have strong reasons to believe the study referred to in the publication never occurred, and that it is a pure fabrication being made by a non-US company to promote their product.  Overusing our treatment tips as suggested by the publication will burn patients. 

We have strong reasons to believe the study referred to in the publication never occurred, and that it is a pure fabrication being made by a non-US company to promote their product.  Overusing our treatment tips as suggested by the publication will burn patients.  

We have conducted a thorough investigation.  We have been unable to locate the supposed author of this study and publication, Michael Stevens M.D., where the study was conducted, any documentation associated with the study other than the study publication, or any of the patients or “experts” who participated in or are referenced in the publication.   

In addition, the data reported by the study is inherently unbelievable.  The study purports to have treated 2,400 patients over a twelve month period (see under “Results” line 1, 1200 patients were treated with reactivated tips, and nine paragraphs earlier reference is made to an equal size control group).  In this industry this would be an enormously large and expensive study (200 patients a month for a year).  Though not impossible to do, it is highly unlikely such a large study occurred (and no one would have heard of it or anyone who was involved in it) given the significant costs and logistics it would require.  For comparison, the largest study we know of involving Thermage is a four year study conducted by Weiss,1 and it only involved 600 patients or one quarter the number Stevens alleges.  In addition, the claims in the Stevens publication are also wildly inconsistent with immense quantities of Thermage quality and reliability data we have compiled on our own products over the years.  We know for a fact the dielectric membrane on our treatment tip will break down when subjected to a tiny fraction of the repeated use this publication alleges can be done.  Dielectric breakdown can result in patient harm.   

So not only does summarizing or republishing a bogus study spread falsehoods, in this case it can endanger patients as well.  The very nature of this study falsely implies that it is a structured, documented and well accepted article.  In fact it is not and the potential use of this study by either a physician and/or patient could lead to poor decision making and patient harm.  We believe it’s in both our best interests to provide the best information possible in order to minimize potential patient complications.  So we ask that you delete your summary blog and link to this publication. 

Of course if you know of any collaborating evidence of any kind supporting either the fact that this study ever happened or the veracity of any of the data or claims made in this publication, we would be very interested in reviewing it.   

We thank you for your cooperation. 

Very truly yours,

Clint Carnell

Vice President of US Sales

1  Weiss, R.A. et. al. Monopolar Radiofrequency Facial Tightening: A Retrospective Analysis of Efficacy and Safety in Over 600 Treatments.  Journal of Drugs in Dermatology – Vol. 5; Issue 8; 707-712; September 2006.

Thermage tackes it's safety reputation among physicians.

This post was written for Medical Spa MD by Thermage.

Thermage Safety - The whole story

Clint Carnell, Thermage, VP Domestic Sales 

 
In reply to your recent blog entitled “Thermage: Do plastic surgeons hate everything non-surgical?”  I am Vice President of Domestic Sales for Thermage:

Much is written about the risks of Thermage, in particular the risk of fat atrophy and surface irregularities referred to in your blog.  Though there were some initial infrequent reports of such effects associated with Thermage after its product was released in 2002, the simple fact is that today Thermage is an extremely safe procedure, and has been so for several years. 

Thermage invented the concept of using non-invasive radio frequency energy for tissue tightening and contouring.  Thermage launched its first product in late 2002.  Though the overwhelming majority of initial treatments were problem free, fat atrophy and surface irregularities were reported in 0.23% of the procedures (2.3 per 1000 patients) in 2002-2003. 

Thermage’s investigation revealed that 100% of the early reports were from 6% of its physician practitioners. 

Our investigation also revealed the cause was over treatment – using excessively high energy settings.  If relatively high treatment settings are used, it is possible to overheat deeper tissue, especially in thin-skinned individuals.  The use of nerve blocks, tumescent anesthesia, and/or intravenous sedation that completely blocked patient pain perception and feedback was also found to be a contributing factor. 

In response to these findings, in January-February 2004, Thermage launched an aggressive physician education program instructing physicians to adopt treatment techniques to avoid tissue overheating.  The techniques included: 

1. Use of a treatment grid to avoid pulse stacking.
   
   
2. Use of multiple passes at moderate power settings rather than single passes at higher energy settings.
   
   
3. Allow 2 minutes between passes to allow temperature reequilibration.
   
   
4. Use patient feedback of heat sensation, and treat to a heat sensation level of 2-2.5 on a scale of 0-4 (4 being maximum sensation).
   
   
5. Use minimal pain blocking.
   
   
6. Pay special attention to patient feedback while treating thin-skinned areas. 

As reported by Narins (1), these new treatment techniques proved to be immensely successful.  During the 6 months following their introduction, the reported incidence of fat atrophy and surface irregularities decreased by a factor of roughly 6 (to 0.04%), and there were no reported incidents in the last half of 2004.  This improving trend has continued to the present.  For example, the reported incidence of fat atrophy and surface irregularities for all of 2006 was 0.016% (less than 2 cases in 10,000).  A similar dramatic decline in all other reported adverse events (e.g., burns, welts, swelling/edema, etc.) has also been observed.  Today, Thermage is an extremely safe procedure. 

In addition to significantly increasing patient safety, the new treatment guidelines have also significantly reduced the discomfort of treatment, since physicians now treat to a very tolerable heat sensation level of 2-2.5. 

Finally, the new treatment guidelines, in particular the use of multiple passes at moderate settings, have also significantly increased efficacy from that reported initially in 2002-2003.  Several peer-reviewed studies show Thermage patient satisfaction to be higher than 80%, and continuing to improve over time.2,3,4  Thermage results are most notably perceptible when it comes to an eyebrow lift or softening of the nasolabial fold, and provide a remarkably natural look.  However, we do acknowledge Thermage results can sometimes be subtle and are not nearly as dramatic as those produced by surgery. 
 

References 

1  Narins, RS, et. al.  Overtreatment Effects Associated with a Radiofrequency Tissue Tightening Device: Rare, Preventable, and Correctable with Subcision and Autologous Fat Transfer. Dermatology Surgery 2006;32:115-124; January 2006. 

2  Weiss, R.A. et. al.  Monopolar Radiofrequency Facial Tightening: A Retrospective Analysis of Efficacy and Safety in Over 600 Treatments. Journal of Drugs in Dermatology – Vol. 5; Issue 8; 707-712; September 2006. 

3  Finzi, E. et. al.  Multipass Vector (Mpave) Technique with Nonablative Radiofrequency to Treat Facial and Neck Laxity.  Dermatol Surg 31 (8 Pt 1); 916-22; August 2005. 

4 Biesman, B. et. al.   Monopolar Radiofrequency Treatment of Human Eyelids: A Prospective, Multicenter, Efficacy Trial.  Lasers in Surgery and Medicine 38:890-898; December 2006.