Q&A
Understanding Lipodissolve™
Facts versus Fiction: Dealing with Critics.

ASAL Lipodissolve® (also known as Lipolysis injections) is the name of a standardized treatment protocol used in treating fat deposits without surgery. The popularity of the mild treatment has rapidly grown among patients and clinics throughout the country. Much of it has come from patient demand.

Lipodissolve was developed by founders of ASAL during the 18 year development of a cardiac diagnostic equipment (H256), when phosphatidylcholine for intravenous use was being investigated.
The procedure was given the name 'Lipodissolve' in 2000 and in 2004 physicians were offered training in the authentic Lipodissolve.

During the early days of liposuction surgery in the seventies and Botox® injections in the eighties, strong opposition was raised from the medical community. Efforts were made to stop patients from receiving these treatments. Today, both liposuction and Botox® represent the most popular cosmetic medical treatments available.

Lipodissolve popularity grew so quick from patient referrals, that over 300,000 treatments were estimated in the U.S. in 2007. As the popularity of Lipodissolve™ grows and expands quickly, controversy and misconception naturally follow. Commercial turf protection efforts has lead to biased criticism of Lipodissolve although the treatment has shown very high safety record, and probably some of the highest safety records of any available non-surgical medical treatment for liposculpture.

Nevertheless, Lipodissolve’s popularity and good safety record proves that the treatment is here to stay. To inform the public and help them better understand Lipodissolve™, we have provided some answers to new questions and discussions recently on the forefront.

What is the meaning of the ASAL 'Lipodissolve'?

Lipodissolve is a unique tradename created to describe the patent pending ASAL Lipodissolve® protocol that has been standardized since 2001 and introduced to physicians in the U.S. since 2004. The theory of Lipodissolve was developed in the early 1990's.

-- Lipodissolve is not the name of a singular medical product (ex. phosphatidylcholine, deoxycholate, PCDC)

-- Lipodissolve is not a general description of nonsurgical efforts to reduce fat, and does not include the meaning of ex. mesotherapy, lipolite, liposculpt, lipomelt, fat jab and so forth.

-- Lipodissolve is not a medical term to describe cosmetic medical treatments that involve injections to reduce fat. The medical term for these types of treatments are generally known as Lipolysis injections.

Due to growing popularity of Lipodissolve this name has been used in pseudo-procedures that are not related to ASAL Lipodissolve.

Was Lipodissolve banned in Brazil?

No.

Brazil had and continues to have issues with black market and unlicensed sale of medicines. This has nothing to do with Lipodissolve as a treatment. Unregulated black market pharmaceuticals were being sold in Brazil in the form of Tiratricol, caffeine, hormones, phoshatidylcholine, aminophyllin and many others. Some of these were black market duplicates of licensed medicines. Laymen were injecting customers in hairsalons and providing medical treatments. Tiratricol and other medications popularized in mesotherapy for sports medicine are not a part of Lipodissolve protocols. ANVISA (the Brasilian equivalent of FDA) banned all unlicensed use of these medications to control the situation. Misuse of medical treatments can occur in all medical fields, including plastic surgery.

Announcements in the media based on faulty concepts, gained from sensationalism and consultation by physicians who have no background in Lipodissolve, or companies that are involved in brand thieving or turf protection, create misconceptions about Lipodissolve.

Efforts to transform mesotherapy from sports medicine to cosmetic medicine a few years back created additional confusion between Lipodissolve and mesotherapy. Lipodissolve had no relation with the 200+ medications used within mesotherapy, or any modified imitation treatments.

Companies like Zipmed, Fig, Dr Midas and others who advertise Lipodissolve are not selling products or instructions that refer to actual ASAL Lipodissolve® protocols. These companies use the Lipodissolve name to promote and gain buyers for their products which may not be a protocol or product for Lipodissolve. ASNA recommend only two pharmaceutical suppliers in the USA for ASAL Lipodissolve™ protocols, and one in Europe.

Is Lipodissolve banned in the UK?

No.

This claim is inaccurate, is old and outdated, and has been published by Lipodissolve critics, mainly commercially motivated physicians. PPC was being imported into the country by unlicensed sellers without verification and sold without prescription. This was against UK regulations. The new regulation created by the MHRA require only pharmacies licensed with the government to sell injectable PPC, meaning verified and licensed companies such as Healthexchange can sell PPC for cosmetic use in the UK, while unlicensed companies cannot and will face fines if they do. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has done the exact right decision needed to control a growing concern: unlicensed sale of medical products.

PPC safety has been well known over the years. PPC has been sold in Europe without prescription for many years but to reduce the risks of misuse this regulation has been changed. The procedure was never banned in the UK and physicians in the country are still using Lipodissolve and being trained in Lipodissolve.

A study on over 10,581 treatments were published by 39 UK physicians in 2006 [Clinical experience and safety using phosphatidylcholine injections for the localized reduction of subcutaneous fat: a multicentre, retrospective UK study; Mark Palmer, MD, John Curran, MD & Patrick Bowler, MD. Journal of Cosmetic Dermatology, 5, 218–226], showing no life threatening conditions and very high safety reports.

ASNA's former affiliates have pressured the drug regulatory bodies in Europe to add prescriptions to the injectable drug to minimize growing misuse.

What is the Lipodissolve update in Kansas?

The Kansas State Board of Healing Arts received many written concerns and complaints from Dr Joel Schlessinger of Nebraska (who is behind most of the negative campaigns against Lipodissolve) and raised an issue on placing restrictions based on these repeated complaints. Its unfortunate that KSBHA has been influenced by one person who is financially motivated to conduct these campaigns. However, the doctors intent was to ban the procedure while KSBHA issued a restriction instead of a ban.

The Kansas State Board of Healing Arts has authorized the use of Lipodissolve by a physician as part of an investigational drug trial. More and more clinical evidence is coming forth on Lipodissolve use, and we foresee better information for State Boards to base their evaluations and decisions on. Hopefully with less influence from deceitful campaigns as those by Dr Schlessinger with paid promoters.

On the website lipotreatmentfacts.org, many claims give the impression that Lipodissolve is illegal or dangerous.

The risks with Lipodissolve have shown to be minimal from thousands of clinical feedback and reports. The medications used are mild and not known to cause major side-effects unless there is an alergic reaction to the medications.

The website lipotreatmentfacts.org is an anonymous site created by paid representatives of a pharmaceutical company. The sources behind this website is in process of creating a competing product and simply want to prepare the market for their own product, by campaigns and discouraging users to utilize Lipodissolve, mesoteraphy or injection lipolysis based on misrepresented facts. Why anonymous? Real facts need not come from anonymous websites. The effort with the site is to use outdated concerns and notices, most that are no longer valid. Or concerns that have been generated in media, originating by the sites own creators. The intentions is to cleverly give the public the wrong impression that Lipodissolve, injection lipolysis, or mesotherpay are banned, have no back-up of research data, are high risk or illegal. Nothing could be further from real fact.

Be cautious to rely on anonymous sources for facts, references, and data about any medical treatment, reviews, device, or substance. These are not trusthworthy sources for information and remain anonymous due to various reasons, i.e,
1) The information may be misrepresented and could be subject to legal consequences for the site owner,
2) The information is old and outdated, making it libel - again a source for potential legal processing against the site owner.,
3) The source has other intentions than real facts or concerns for patient safety.

There are often many reasons why critics remain anonymous, and often these reasons are commercial or monetary in nature, and can therefore not be a real or reliable source for information.

Is phosphatidycholine safe?

Phosphatidylcholine is a very safe product although some risks should be expected with any medical product or treatment. The fear mongering about phosphatidylcholine (PPC) and especially by paid physicians backed by pharmaceutical companies, has become somewhat absurd and exaggerated. PPC is a simple flavonoid that unfortunately has been presented in the press with the seriousness of a dangerous narcotic. There have been hundreds of studies on PPC safety for human use published in medical journals world-wide over a period of 50 years, including FDA studies. PPC is even recommended as safe for use on children in higher dosages than what is used in ASAL Lipodissolve®. PPC is responsible for emulsifying lipids in bile. PPC has no reports of any toxicity from any human studies. The mild components of phosphatidylcholine are well known within the scientific community. Studies on lipid biochemistry state that PPC is absorbed quickly meaning that within hours of injection or oral consumption, there is no residue of PPC remaining in the body. The remaining effect from ex. Lipodissolve treatments, is the body's own process of healing.

And phosphatidylcholine for cosmetic use?

2007 PPC studies on rabbits have shown destroyed fat is eliminated by the macrophages. One theory brought forth is that the reduction of subcutaneous fat is likely attributable to inflammatory mediated necrosis and resorption. The same study and other studies have proven that this treatment indeed works. Untrue reports by some media claim that there are no studies and no evidence that Lipodissolve actually works. On the contrary, in the rabbit study there was difficulty palpating the site for reinjection in the PPC injected rabbits because the volume of fat was decreasing while the control group had no such evidence. Claims that PPC is unsafe or that there exist no studies are simply the result of poor quality journalism. ASAL founders were the original developers in the world of the theory of PPC use for cosmetic indications. PPC in cosmetic use has been imitated and recycled so much, that accurate information has become difficult to distinguish. ASAL is therefore more keen at present to focus on new product development.

Recently, the biochemical mode of action taking place in Lipodissolve has been studied by the Center of Molecule Medicine in Germany and the results from these studies were published in 2009. This study showed a profound adipocytolytic effect which was at its peak within 15 minutes of injections. So there exist research evidence that Lipodissolve actually works. To learn of the latest developments in Lipodissolve, sign up for the ASNA course.

Safety concerns have not been immediate with PPC use and more studies are always preferred, especially long-term studies. What is more essential to pay attention to is whether clinics add other substances into their medications that may cause risks. In Europe the practice of medicine is still conservative and experimentation with Lipodissolve is rather unsual. But in the United States many are eager to reinvent the procedure within days of attending a seminar, with their own concoctions in hope of sudden commerical gain or media attention. For this reason, patient reports and impressions differ from treatments depending on where they had their treatment. In spite of this, the safety is high compared to other asthetic treatments to reduce fat deposits and the sheer volume of treatments being done.

How is PPC best useful in Lipodissolve?

To be effective PPC must be manufactured within a certain set of parameters if it is applied for cosmetic use. This fact has been known to the original developers, ASAL, for many years. The expanding knowledge and development with Lipodissolve has had an uphill struggle over the years. Phycisians did not believe in the theory at first, and there was very little interest from both companies and doctors until quite recently. In addition, PPC availability in this country, and in the right format, was not easily available for purchase until only a few years ago.

If the parameters in PPC compounding are completely off it may be unecessarily uncomfortable or have other unsatisfactory effects. In the ASAL Lipodissolve several compositions of mild pharmaceuticals (or rather, micronutrients) are being used, with PPC as the main active ingredient. In contrary to reports, all compounds in ASAL Lipodissolve have licensed approval for other indications than cosmetic use. It is our wish that the compounds should be licensed and approved for cosmetic use according to the ASAL protocols. Until then it would be advisable that regulatory bodies continued permitting its use, but monitor clinical use regionally by verifying protocols and demanding regular case data.

With the right protocols by trained physicians Lipodissolve is mild and effective. Lipodissolve has been called 'the greatest discovery in aesthetic medicine since Botox®". It can offer a new way of eliminating fat, not only for cosmetic purposes, but potentially also for health reasons (ex. reduce pure fat to reduce the development of heart disease and diabetes, a common problem in obese individuals).

Has phosphatidylcholine been licensed for approval with any brand?

PPC is approved for medical use in every country throughout the world. In the United States PPC is approved in other licensed drugs, ex. InfaSurf and Calsurf [surfactant preparations], Ablecet [for fungus treatment] and Rapamune [HIV drug].

Why are some critical against Lipodissolve?

The objections against Lipodissolve is questionable. Life threatening reactions have never been reported in thousands of cases of actual Lipodissolve treatments in the past four years of use in the USA or Europe. Minor side-effects are commonly known, and are mild. Rare side-effects can be limited by proper patient consultation. Sensible concerns have been raised on imitation procedures touted as Lipodissolve. But individual cases of misuse is not an accurate assessment of Lipodissolve.

If the primary concern was patient safety from those opposing Lipodissolve, they would be more keen to welcome a treatment with milder side-effects and a new and potentially safer method for the interest of their patients, and improve the method best possible. Liposuction has been promoted by the surgeons who perform them, as “the only safe” treatment to reduce body fat. But fatalities and many other dangerous side-effects and long-term complications resulting from liposuction are a well known fact (FDA web notice, 41). How the word ‘death’ fits into the description of 'only safe' procedure can only be answered by the plastic surgeons that perpetuate this claim. In recent reports, FDA declared annual liposuction deaths greater than annual data of death from car accidents.

The fact is, while liposuction is a dangerous and aggressive cosmetic procedure, it offers the right candidate a tool to achieve the cosmetic results they want. The surgeons skill is essential for both safety and results and the method itself is not at fault. Lipodissolve has minimal immediate dangers, and it too offers good to excellent cosmetic results on the right candidate and need a physicians skill. Neither of these treatments can be judged on individual cases of misuse. For liposuction patients, Lipodissolve can aid in correcting post-surgical deformities.

Professional objection raised against Lipodissolve mainly originate from;
1) biopharmaceutical corporations and their representatives intending to capture the market with their own patented brands (ex. recent nationwide criticism of Lipodissolve by Dr Joel Schlessinger, Nebraska, a researcher for Kythera Biopharmaceuticals)
2) turf protection by clinics and companies
3) the concern of losing profits or patient numbers in a very competitive market,
4) concerns that too many cosmetic treatments are becoming simplified and being taken over by medical spas, or are being run by non-physicians (ex. criticism raised by plastic surgeons)

While a few surgeons are opposed to Lipodissolve for various reasons, there are also plastic surgeons who support the treatment fully and find it to be an important addition to their clinical practice that can aid them to achieve greater cosmetic results and patient satisfaction.

Other and more serious concerns for us is the use of the ASAL Lipodissolve® name by companies that have no relationship to protocols used in ASAL studies.

Companies such as Go Fig and Advanced Lipodissolve Center, are not certified by ASNA in the ASAL Lipodissolve®. The public confusions caused by such advertising has become a major concern for ASAL Lipodissolve® development.

What is the positive satisfaction level?

The ASAL Lipodissolve® has been free from commercial biases or influence by pharmaceutical manufacturers. This means that Lipodissolve gained its growing popularity from patient use and satisfaction - not from product advertisement. The patient satisfaction from Lipodissolve therapy is very high, and is often higher than that from treatments by most major cosmetic medical equipment. 20 Reported patient satisfaction from the ASAL Lipodissolve sessions provided to us by trained physicians normally run at least +85% within the average satisfaction mark. 21 In European studies on liposuction cases from in 2005, 1 in 10 liposuction cases reported post-surgical deformities and dissatisfaction from surgeries that were difficult to correct. In a US study from 2004, the patient dissatisfaction level from liposuction surgery was as high as +20%, even higher than in the European study. 43 Other reports state that over 50% of patients have fat return to the treated area over one year after liposuction surgery.

Why has the pharmaceuticals not been FDA approved?

The issue is the cost factor. There are no unknown drugs used in the ASAL Lipodissolve® that do not have an existing database of research behind them. Ex. Phosphatidylcholine, one of the main active ingredients in ASAL Lipodissolve®, is approved as ingredient with licensed drugs for other indications in the United States, ex. InfaSurf and Calsurf, Ablecet and Rapamune. All are sold on prescription basis.

There are conflicting views whether supplements like phosphatidylcholine, or ex vitamin injections, that have a long-standing safety record of use require further approval. In Lipodissolve use, the ingredients have been prepared by a compounding pharmacist upon a physician's order (FDA Modernization Act Section 503a Compounding Pharmacy).

The use of medications for other indications than the original intended use (off-label) is a common occurrence within cosmetic medicine. Over 65 % of cosmetic procedures offered to patients in the USA are provided or performed through off-label use. If we refer to cosmetic procedures, plastic surgeons often publish completely new procedures from their own private efforts where no prior studies or documented data exist on the safety of the new use. Therefore, it is nonsensical that this particular group, that deviate so frequently from FDA approval requirements, have suddenly become so concerned about Lipodissolve use and issue public warnings. Where are the warnings of their own modifications or new drug use with procedures that have no data behind it? New procedures are developed with the confidence in the physicians medical know-how. If there are obstructions made to this rule, we will continue using old and maybe outdated methods that may be more risky than newer discoveries, and obstruct or delay new treatments to be made. It may further exclude new discoveries only to pharmaceutical companies, who may focus too much on commerically motivated aims and not always be in the best interest of the public.

The main reason that the pharmaceuticals in the ASAL Lipodissolve® have not been licensed for cosmetic use is the high drug-licensing cost. For example, phosphatidylcholine (PPC) , the most talked about ingredient in the ASAL Lipodissolve® protocol, has been on the market for so many years that manufacturers don’t feel justified in absorbing the cost of licensing it for another indication, even if the composition differ from standard PPC. This is a pity since cosmetic results improve depending on how phosphatidylcholine is processed and the phosphatidylcholine recommended in Lipodissolve is of higher standard than most choline sold in the United States. ASNA welcomes inquiries from biopharmaceutical companies interested to proceed with licensing procedures for phosphatidylcholine for cosmetic use.

An example of a common off-label use is Botox®. Botox® is FDA approved only for reducing frown lines between the eye-brows. It is not approved for other indications (ex. for cosmetic use around eyes, lips, forehead, for sweating, etc). All other use of this drug is termed “off label use”. Recently there has been 16 deaths reported from Botox® use in the United States, although the product is researched and FDA approved. Pharmaceutical companies will not invest money in licensing to approve every aspect of the products use unless they see it financially viable.

Is the ASAL Lipodissolve® "FDA approved”?

This question needs clarification and is miscategorized:

ASAL Lipodissolve® is not the name for a drug or a medical device. The actual treatment protocols itself does not fall within the category for FDA approval. With Liposuction, it is the medications and equipment used in the surgery that have been FDA approved and not the procedure or the name Liposuction. Often the approval is proven safe for one indication only, but are being used “off label” for various other indications where there is no approval.

• More than 20% of all drugs in the USA are prescribed "Off Label".
• More than 50% of cancer patients receive drugs "Off Label".
• According to some estimates up to 90% of newborns receive off label drugs.
• An estimated 65% of all product use in cosmetic procedures within plastic surgery and/or aesthetic clinics are performed “Off Label”.

Should a ban be added on all these treatments and uses of medications? Or should the responsibility of use be restricted to the medical knowledge of the user and the manufacturer? FDA does not regulate medical treatments. FDA regulates the licensing for drug and medical device manufacturing and sales in the United States.

The tradename ‘Lipodissolve’ (pending approval) refers to a standard treatment protocol created by ASAL that is unique for this particular procedure. The ASAL Lipodissolve™ medical treatments have been clinically tested, documented with follow-up data. It should be used by members that have been certified and who conform to our policy where actual Lipodissolve protocols must be used. Physician members who change the treatment protocols or alter the medications should not be using the name Lipodissolve in their treatments. All medications are manufactured by licensed pharmacies, monitored and enforced under state and government regulations.

The FDA has described their role as follows:  “In the United States, the Food and Drug Administration (FDA) regulates the sale of medical devices, such as the equipment (canulas, pumps, collecting containers, ultrasound probes, etc) and drugs (anesthesia) used for [ex.] liposuction” And more, “Once the FDA has approved or cleared a medical device, a doctor may decide to use that device [or drug] for other indications if the doctor feels it is in the best interest of a patient. The use of an approved or cleared device for other than its FDA-approved indication is called ‘off-label use’.”
FDA has posted examples of what they do not do: “The FDA does not have the authority to regulate a doctor's practice. In other words, FDA does not tell doctors what to do when running their business or what they can or cannot tell their patients; [FDA does not] make recommendations for individual doctors, clinics, or centers.” 41

What are surgeon’s public views on Lipodissolve?
And how safe is the ASAL Lipodissolve™ compared to liposuction?

Plastic surgeons are not particularly happy and there are opinions that new treatments provide financial competition. Dr. Michael Olding, Chief of Plastic Surgery, George Washington University, issued a statement “Lipodissolve is not approved by the FDA” in the Washington Post on June 27, 2007. Dr Olding continued to answer questions about the ASAL Lipodissolve® as a consultant for the newspaper although he has never used Lipodissolve in his practice, has not been certified through us and has no direct knowledge of the treatment. He states, “liposuction (both standard and ultrasonic) have been proven to be safe and effective“. 40 However, the FDA never claim these procedures are safe but describes liposuction as having a long list of high and known risks such as; infections, embolism, visceral perforations (puncture wounds in the organs), seroma, nerve compression and changes in sensation, swelling, skin necrosis (skin death), burns, fluid imbalance, toxicity from anesthesia and death. 41

Hardly an impressive safety list.

Many patients who have had liposuction report consistent fluid imbalance for years after surgery that appear to not stabilize. This imbalance cause a fluctuation of 1-2 dress sizes in a single day. Another common complaint in liposuction patients, is permanent post-surgical deformities. 42 A third complaint is that results don't last.

Other unknown side-effects contain no FDA-approved studies whether these reactions pose a long-term safety issue or not for patients that have had liposuction. In a 2004 study on only 209 patients 43% had gained weight within 1 to 2 years since their liposuction, with most reporting a weight gain of five to 10 pounds. Keep in mind that these patients gained their weight although a considerable amount of fat cells had been permanently removed. Patient dissatisfaction with liposuction was as high as +20% according to this study. 43

In a study by Eric Finzi, MD, PhD in 2003, breast enlargement occurred in 43% of patients who underwent one or more tumescent liposuction surgeries. 45 There exist no FDA-guided study by plastic surgeons to date after over 30 years of liposuction use, to evaluate safety whether an increase in breast size after liposuction pose an increase in breast cancer cases. Or whether the sudden weight gain in the 43% group from the former study have a permanent or long-term adverse biological effect on the body. Another study by Dr Klein, published in June 2004 in the New England Journal of Medicine reported an absence of effects of abdominal liposuction on cardiovascular risk factors, inflammatory markers, and insulin resistance in obese women as had been previously claimed, showing that liposuction had no particular health benefit apart from cosmetic. 44 After years of use the ASAPS still provide no annual data for public view of the number of deaths per year from liposuction. Long term effect on patients after liposuction is not available either. In other words, the actual facts have been poorly presented by the surgeon community.

Dr Olding states that some of the positive cosmetic results from the ASAL Lipodissolve® may be due to the weight loss alone?

No true. Lipodissolve reduces pure fat. In a 2009 study by the Center for Molecular Medicine in Germany, more than 90% of cell death occurred after 90 s in preadipocytes, after 6 min in vascular smooth muscle cells, skeletal myotubes and renal epithelial cells, and after 15 min in adipocytes from Lipodissolve injections.

In the majority of patient cases, actual weight loss is insignificant compared to the loss of inches achieved from the ASAL Lipodissolve® treatments. There have been cases where our physicians have achieved 9 and even 13 inches of circumferral loss on patients (Lipodissolve of the abdomen) while a weight loss of no more than 2-4 lbs was noted. But this kind of loss of inches is not standard and is mostly due to the patient suffering fluid retention. On average, a patient will lose about 1-1.5 inch per treatment and more depending on treatment protocol, patient metabolism and body type, medications and if aftercare was given.

Why does ASNA require that nurses can only be certified along with their supervising MD?

It is very important for us that physicians that bring nurses and other clinical staff for training, assure they provide actual on-site supervision of Lipodissolve. ASNA will reject applicants if RNs or clinical staff are known to provide medical treatments and patient consultation on their own without a physicians supervision and this is a violation of our policies. If non-physician medical staff provide Lipodissolve treatments, or open clinics without the presence of a doctor that has a clear understanding of Lipodissolve after being certified by us, they violate our policies. If anyone certified through us alters or modifies the medications or treatment protocols, they violate our policies.

Many states have strict policies as to the nonphysicians role in a clinical practice. The California Medical Board, f.ex., expressed its position on medical cosmetic practices in an October 2002 Action Report. The report also presented information on specific categories of nonphysicians that are allowed to use medical lasers, dermabrators, Botox® and other types of cosmetic treatment. Per this report, “unlicensed medical assistants, licensed, vocational nurses, cosmetologists, electrologists or estheticians may not legally perform these [cosmetic] treatments under any circumstance, nor may registered nurses or physician assistants perform them independently, without supervision.”

Physician supervision of nonphysicians performing cosmetic services is important to assure quality of treatment and compliance to the standard of medical care. Just as it is wise to educate nonphysicians about potential risks and complications of cosmetic procedures, it is also sensible to develop policies and protocols for supervision. While developing such policies and protocols physicians might consider the following recommendations:

            • Precisely outline roles and responsibilities of nonphysicians.
            • Specify types of cosmetic procedures that nonphysicians are allowed to perform.
            • Indicate requirements for appropriate training and certifications.
            • Describe possible risks and complications of cosmetic procedures.
            • Develop specific instructions for emergency situations.

The physical presence of physicians in the office is recommended to assure proper implementation of the above steps and to provide care as needed. 46

[This page may be updated regularly]

Footnote:
What does the FDA regulate?
In the United States, the Food and Drug Administration (FDA) regulates the sale of medical devices, such as the equipment (canulas, pumps, collecting containers, ultrasound probes, etc) and drugs (anesthesia) used for [ex.] liposuction.
Before a medical device can be legally sold in the U.S., the person or company that wants to sell the device must seek approval from the FDA. To gain approval, they must present evidence that the device is reasonably safe and effective for a particular use, the "indication." Once a device is approved, other similar devices may be cleared by the FDA for use. This requires less information since an equivalent device has already been shown to be safe and effective. In some cases, devices that were on the market before FDA started regulating medical devices may be cleared. Once the FDA has approved or cleared a medical device, a doctor may decide to use that device for other indications if the doctor feels it is in the best interest of a patient. The use of an approved or cleared device for other than its FDA-approved indication is called "off-label use."
The FDA does not have the authority to:

• Regulate a doctor's practice. In other words, FDA does not tell doctors what to do when running their business or what they can or cannot tell their patients.
• Set the amount a doctor can charge for liposuction surgery.
• "Insist" that patient information be provided to the potential patient.
• Make recommendations for individual doctors, clinics, or liposuction centers. FDA does not maintain nor have access to lists of doctors performing liposuction.
• Recommend a physician to you.
• Conduct or provide a rating system on medical devices it regulates.

 
References:

20. Lipodissolve: 2004 Members Report.

21. Lipodissolve: 2005-6 U.S. Members Follow-up reports

40. Q&A in the Washington Post: Does Lipo-dissolve Work? Dr. Michael Olding
Chief of Plastic Surgery, George Washington University. Thursday, June 28, 2007; 3:00 PM

41. FDA patient information: www.fda.gov/cdrh/liposuction and www.fda.gov/cdrh/liposuction/risks.html

42. Forum: www.liposuction4you.com

43: Rohrich, R. Plastic and Reconstructive Surgery, December 2004; vol 114: pp 1945-1952. Rod Rohrich, MD, professor and chairman, department of plastic surgery, University of Texas Southwestern Medical Center, Dallas. Patrick McMenamin, MD, cosmetic surgeon. News release, American Society of Plastic Surgeons. American Academy of Cosmetic Surgery.

44. Metabolic Effects of Liposuction — Yes or No? New England Journal of Medicine, Volume 351:1354-1357  September 23, 2004. Dr Klein's addition was published in June 17 issue of the publication.

45. Eric Finzi MD, PhD (2003): Breast Enlargement Induced by Liposuction
Dermatologic Surgery 29 (9), 928–930. doi:10.1046/j.1524-4725.2003.29252.x

46. Cosmetic Procedures in Physicians’offices: An Emerging Liability Issue; October 2006, Norcal Mutual Insurance Company, “ClaimsRx’.

47. Lipid Biochemistry. Gurr, Harwood, Frayn; Blackwell Science, 2004; 5th edition.

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3.        Schneider M. Phospholipids. In: Gunstone FD, Padley FB, eds. Lipid Technologies and Applications. New York, NY: Marcel Dekker; 1997:15-30.

4.        Kent C. Eukaryotic phospholipid biosynthesis. Annu Rev Biochem 1995;64:315-343.

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6.        Kidd PM. Cell membranes, endothelia, and atherosclerosis -the importance of dietary fatty acid balance. Altern Med Rev 1996;1:148-167.

7.        Kidd PM. Phosphatidylcholine, a superior protectant against liver damage. Altern Med Rev 1996;1:258-274.

8.        Zeisel SH, Da Costa K, Franklin PD, et al. Choline, an essential nutrient for humans. FASEB 1991;5:2093-2098.

9.        Wurtman RJ , Hirsch MI, Growdon JH. Lecithin consumption raises serum free choline levels. Lancet 1977;ii: 68-69.

10.     Buchman AL, Dubin MD, Moukarzel AA, et al. Choline deficiency: a cause of hepatic steatosis during parenteral nutrition that can be reversed with intravenous choline supplementation. Hepatology 1995;22:1399-1403.

11.     Ghyczy M, Boros M. Electrophilic methyl groups present in the diet ameliorate pathological states induced by reductive and oxidative stress: a hypothesis. Brit J Nutr 2001;85:409-414.

12.     Thistle JL, Schoenfield LJ. Bile acid, lecithin, and cholesterol in repeated human duodenal biliary drainage: effect of lecithin feeding. Clin Res 1968;16:450.

13.     Toouli J, Jablonski P, Watts JM. Gallstone dissolution in man using cholic acid and lecithin. Lancet 1975;ii: 1124-1126.

14.     Lloyd J, Todd DA, John E. Serial phospholipid analysis in pre term infants: comparison of Exosurf and Survanta. Early Human Dev 1999;54:157-168.

15.     Dunjic BS, Axelson J. Gastroprotective capability of exogenous phosphatidylcholine in experimentally induced chronic gastric ulcers in rats. Scand J Gastroenterol 1993;28:89-94.

16.     Lieber CS, Leo MA. Polyenylphosphatidylcholine decreases alcohol-induced oxidative stress in the baboon. Alcoholism Clin Exp Res 1997;21:375-379.

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