The Food and Drug Administration (FDA) issued warning letters to six medical spas across the country yesterday. The letters accused them of making false or misleading statements on their marketing materials and websites about treatments they claim will eliminate fat. These procedures are called “Lipodissolve”.

The warning letters go on to accuse the spas for misbranding Lipodissolve products. The spas have made unfounded claims that the drugs they use for their lipodissolve procedures are safe and effective. Yet, these procedures have neither been evaluated nor approved by the FDA.

The companies involved have been cited for a variety of regulatory violations, including making unsupported claims that the products have an outstanding safety record and are superior to other fat loss procedures, including liposuction.

The Spas Cited are:

• Monarch Medi Spas, King of Prussia, PA
• Medical Cosmetic Enhancements, Chevy Chase, MD
• IDinHealth, Edina, MN
• All About You Med Spa, Madison, IN
• Spa 35, Boise, ID
• Pure med Spa, Boca Raton, FL

Some of the letters indicate that the companies have said that lipodissolve products can be used to treat certain medical conditions. These include male breast enlargement, benign fatty growths known as lipomas, excess fat deposits, and some surgical deformities.

The FDA stated that they are unaware of clinical evidence to support any of those claims.

What is Lipodissolve?

Lipodissolve is touted to be fat dissolving procedure that is less invasive than liposuction, a surgical procedure that literally sucks the fat from the patient with a surgical vacuum. The Lipodissolve procedure has also been called “mesotherapy”, “lipozap”, “lipotherapy”, or “injection lipolysis”. Either way, it’s primarily all the same treatment.

The Lipodissolve procedure involves a doctor or technician injecting the patient with a drug and herbal mixture intended to dissolve and permanently remove small pockets of fat from isolated parts of the body. The most commonly injected drugs are phosphatidylcholine and deoxycholate, usually in various combinations with one another.

Phosphatidylcholine – This is considered part of the Lecithin group of fatty acids that occurs in many animal and plant tissues. It is a vital substance that is in every cell in the human body. It depletes considerably in our cells as we age and its depletion has been speculated by some in the science community to contribute to the aging process.

Deoxycholate – This acid is one of the secondary bile acids, which are metabolic byproducts of intestinal bacteria. It helps the body absorb fats into the intestine and generally helps the patient pass them naturally. It usually comes in a white powdery substance.

Herbal Combinations – These can be a vast variety from harmless to marginally helpful. These combinations are more than likely specific to the spa offering the treatment and should be listed in procedural materials as to avoid allergic reactions.

What Are Lipodissolve Side Effects?

As with any relatively new procedure the side effects take time to realize. As this is essentially untested by the scientific establishment and the FDA, a comprehensive list has not been able to be compiled.

Through research done in this blog we have been able to comprise a list of possible side effects from medical data, FDA reports, and customer comments. Please note that this list is not scientific research or part of a medically endorsed research project.

Some of the side effects include:

• Post Procedure Lightheadedness – Reports are that this passes relatively quickly, within minutes to hours.
• Post Procedure Nausea – The causal effect is unknown at this time.
• Tenderness and Pain in the Treated Area – This has been reported to last up to several days to several weeks after the procedure.
• Bruising – There have been concerns that the discoloration lasts for a disproportionate amount of time.
• Scarring – Scars are permanent signs of the procedure that may require further plastic surgery to remedy or may have no remedy at all.
• Skin Deformation – These are areas of either sagging, wrinkled, or stretched patches of skin in the treatment areas that may require further plastic surgery to remedy.
• Hard Nodules in the Treated Area – There was not specific data or follow up as to the nature of these nodules.
• Serious Infection – There is a possibility of serious infection of the procedure area. It has been recommended that patients should avoid tight or restrictive clothing around the treatment areas during the healing period. These internal infections can get into the blood stream quickly and cause a series of other non-procedure related complications. If not caught soon enough these infections could cause death.

Explanations

The FDA has requested written responses from the spas within 15 business days of receipt of the warning letters. They as that the companies state how they intend to correct these violations and prevent future violations. Each warning letter stated clearly that failure to comply with the request and promptly correct the violations may result in legal action.

“We are concerned that these companies are misleading consumers,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “It is important for anyone who is considering this voluntary procedure to understand that the products used to perform lipodissolve procedures are not approved by the FDA for fat removal.”

Protecting the Patient

These elective cosmetic procedures are very popular and growing in popularity everyday. They are generally run by trained and certified medical staff. Yet, since Lipodissolve is not an approved procedure by the FDA or the larger scientific medical community, there is no certification for the procedure. This means that there have been no standards set to assure the maximum care and protection of the patient.

The standards of the mixture used to conduct the procedure is also not standardized or approved. This means that effectiveness and side effects could vary greatly from one facility to the next. This also makes claims of effectiveness almost impossible.

We recommend that you only subject yourself to FDA approved and fully researched procedures that have a proven track record of their effectiveness. Approved procedures have standardized methods and drug mixtures that both protect the patient and give a clear set of results and side effects.

If you or someone you know has had one of these “fat dissolving” injection treatments under any name, and have found that they have suffered from adverse side effects, permanent disfiguration, or serious personal injury due to infection it is important that you find council that is experienced in Medical Malpractice lawsuits. Call Phillips Webster for a consultation as to your legal recourse.

Learn More About:

• Settlements in Medical Malpractice Lawsuits
• Filing a Medical Malpractice Lawsuit
• Causes of Medical Malpractice

Healthcare is a stressful job on a good day. Many healthcare professionals are faced with life or death decisions, terminal patients, and emotionally charged loved ones. It takes a special person to face up to the challenges and sometimes these individuals falter.

This month two healthcare professionals faced strict discipline charges for substance abuse. When one thinks of substance abuse in healthcare professionals it generally brings to mind prescription drugs that seem to be readily available, but these cases do not involve the obvious.

Showing that healthcare professionals are vulnerable humans just like the rest of us, the Department of Health has cracked down on these individuals for alcohol abuse. This ailment can be highly detrimental to their patients by hampering their decision making skills, affecting essential motor skills, and potential misdiagnosis.

If a doctor is diagnosing and operating, even after a drinking binge, it could lead to serious personal injury and medical malpractice lawsuits.

DUI Doctor

When a doctor gets a DUI it is an issue of bad decisions and usually affects their career and reputation, but rarely impacts their license to practice medicine. In the case of Dr. Sarah S. Reade, who is a specialist and surgeon who specializes in internal medicine, a DUI was a sign of a larger problem, a serious mental problem.

The Medical Quality Assurance Commission and Department of Health revoked Olympia physician Sarah S. Reade’s license after she was charged with driving under the influence of drugs and/or alcohol in December.

The suspicions began with Reade having a terrible Christmas Day in 2009. Reade was arrested for DUI and spent a solemn Xmas night in the Nisqually jail, according to Department Of Health documents.

Her father called Thurston County Sheriff’s deputies the next day and told them he was concerned about his daughter’s mental state. When deputies responded by going to her home, where they reported they found it “cluttered and strewn with clothing, disrupted furnishings, household garbage, animal feces and bottles of liquor,” the documents say.

The doctor admitted she had been drinking.

Reade’s downward trajectory continued into the weekend. Two days later, she called 911 and warned that she was going to slit her wrists with a scalpel. When the deputies showed up, she sprayed them with a garden hose and shouted profanities at them.

This is not the first disciplinary action against her. The Olympia native had her license suspended in 1998. She fought that suspension and won. Then in 2005, the commission put Reade on probation due to another DUI in which she crashed into a tree. She was required to complete an alcohol-treatment program. She was not working as a doctor at the time.

Narcotic Nurse

The state Department of Health is disciplining Karen Marie Erickson, a licensed practical nurse, whose urinalysis came back positive for traces of oxazepam, a prescription drug used to treat anxiety and acute alcohol abuse.

Though she seemed to be taking a drug to treat her alcohol abuse, her urine also register for marijuana and cocaine, the DOH statement sent March 9^th said.

A DOH investigator sent Erickson two letters in July to her last known address, asking Erickson to explain her conduct. Both letters came back with a note that she had moved and left no address.

Her license expired that same month, but the Nursing Care Quality Assurance Commission is still considering sanctions.

Department of Health Discipline

Upon examination of the DOH disciplinary database, the agency has been clamping down on substance abuse as of late. There was no indication of a formal announcement of these actions, but it is very good for patients.

Every month for late 2009 & 2010 there seems to be at least two or three disciplinary actions around the state regarding non-prescription substance activity. The personal problems and conduct of healthcare workers can adversely affect the health and welfare of patients. This is serious for institutions also who take the brunt of medical malpractice lawsuits associated with this conduct.

Medical Malpractice

It is important that the institutions monitor their staff also. Before the Department of Health steps in, the signs of substance abuse, inappropriate or unusual behavior, or erratic moods are clear to their managers and coworkers. Some of the signs that a coworker is abusing alcohol are:

• Excessive sick time
• Disengaged or distracted behavior
• Lateness and bad schedule maintenance
• Erratic mood swings
• Sleepiness or excessive fatigue
• Excessive drinking during work parties
• Bottles in personal storage areas
• Drinking during breaks
• Drunkenness during shift
• Smelling of alcohol during shift

If the institution does not recognize these signs and engage in some sort of discipline prior to DOH action then they could be putting patients at risk.

If you or someone you know suspect that your healthcare provider has misdiagnosed you or has inhibited care through inappropriate behavior or substance abuse it is important that you find an experienced attorney to inform you of your legal rights. Call Phillips Webster for a consultation.

Learn More About:

• Damages Covered by Medical Malpractice Awards
• Anesthesiology Mistakes
• Surgical Errors

In August of 2009 the Swedish Medical Center staff received a shocking complaint. A patient at their Outpatient Rehabilitation Services Center – Cherry Hill reported that one of their physical therapists had inappropriately touched her breasts.

Upon further investigation they found out that Michael James Shannon, 38, was the alleged groper.

Shannon was placed on administrative leave shortly after the complaint. He was returned to duty after claiming he was examining the woman’s shoulder and did not touch her within several inches of her “privacy areas,” according to court documents.

A Pattern Arises

They thought that the matter had been settled until authorities say a second patient came forward two weeks later claiming an identical violation. That’s when the authorities were brought in.

“This time, there was no indication that Shannon should have been assessing that area of the patient’s body,” a Seattle detective noted in documents.

“Shannon’s supervisor did not find Shannon’s account credible and was concerned that ‘there may well be a pattern (of) patient abuse,” she added.

In the documents charging him, King County prosecutors say that he groped two patients and lied to each by telling them that his groping was part of their therapy.

Legal Wrangling

Following the allegations Shannon was immediately fired from Swedish Hospital as their legal team swung into action trying to salvage this mess.

Along with the Swedish Hospital and state investigations, the two women’s complaints prompted a Department of Health investigation. The DOH investigation has resulted in a preliminary injunction against Shannon. While he’s still allowed to work as a physical therapist, he’s barred from contact with female patients under the terms of the Department of Health order.

These kinds of allegations are very serious and can ruin an individual’s reputation and career, particularly when under the employment of perhaps the largest medical facility in the State of Washington. That’s probably what prompted Shannon on March 2 to request an administrative hearing be held by the Department of Health regarding matter. That hearing has not yet been scheduled.

Prosecutors, on the other hand, asked King County Superior Court Judge Sharon Armstrong to order that Shannon be barred from work as a physical therapist until the case against him is concluded.

Shannon is charged with two counts of indecent liberties. He has not been jailed in the case.

The Defendant Flees the Country

Embarrassing situations make people do the oddest of things.

According to court documents, apparently Shannon had left the country “with his wife for her job” prior to charges being filed or the Department of Health action.

The documents do not reveal what country they fled to and if Shannon has agreed to return for the state hearings and the DOH hearings regarding the matter.

“The defendant reported to the Department of Health that he is working as a physical therapist, but he refused to divulge where he is working,” Senior Deputy Prosecutor Carol Spoor told the court. “Thus, he continues to have access to patients, where he may continue his offense pattern.”

Medical Malpractice

A physical therapist is a medical practitioner that has the trust of his patients literally in their hands. Many patients are coming out of serious accidents, spinal cord injuries, burn injuries, brain injuries, and amputation. Many times they turn to their physical therapist for inspiration and hope. The therapist helps them overcome their tribulations and celebrates their triumphs. Many times they form a very close bond. When that trust is broken it severely hampers or even sets back a patient’s recovery. It can cause them to do avoid therapy or attempt to do it on their own which can cause serious personal injuries.

If you or a loved one have found that you’re a victim of medical misconduct by a health care professional be it sexual or otherwise, it is imperative that you find experienced legal council to help you through this trying time. Call Phillips Webster for a consultation on your legal options.

Learn More About:

• Washington Medical Malpractice Laws
• Medical Malpractice FAQs
• Surgical Errors

A study was released today that may have passed under the radar of most, but may just shock some, especially in the local Seattle area since questions like those asked in this survey are asked by parents everyday at Seattle Children’s Hospital.

The study was published in the Archive of Pediatrics and Adolescent Medicine. The study surveyed 141 parents who had lost their children to terminal illnesses like cancer. The nature of the study was to find out how many parents with a child in physical pain  due to a terminal illness like cancer, had considered drastic measures to end their child’s life early. A term generally referred to as euthanasia.

The Study

The 141 parents surveyed had had children who died in hospitals in Minnesota and Boston.

Thirteen percent of parents with children that were terminal considered hastening the process.  A few even acknowledged that they asked doctors to use fatal doses of medication to end the child’s suffering for good.

The study goes on to say that nine percent of the parents had brought the option up with a medical practitioner. In the study the parents of five children said they “explicitly requested” it from a doctor. Three sets of parents confirmed that the doctor had agreed to administer a lethal dose of morphine.

According to the study, in hindsight, 34 percent of the parents said they would have considered euthanasia for their child if the child had been suffering from “uncontrollable pain.”

Fifty percent of those surveyed supported the right for parents to make choices regarding the early death of their child in cases of an excruciating and imminent death.

“If there was absolutely no other option, and the patient is suffering, then why wouldn’t you” hasten death? said David Reilly, a Boston-area man whose 5-year-old son died of cancer 11 years ago.

The Study Authors Comment

The study refers many of these cases as “hastened death” rather than euthanasia. This can lead to serious medical malpractice charges in most states. Regardless of their name are officially opposed by the American Pediatric Society who have stated officially that they prefer palliative care (care to reduce pain by no longer treating the disease with painful methods).

“Desires for hastened death may represent an exit plan to be used if no other alternatives are recognized,” they write. “If physical suffering is identified, our results suggest that parents are willing to have an open discussion about existing options … such as proportionately intensive symptom management and palliative sedation.”

The study’s authors explicitly do not suggest that doctors were hastening death on any of their young patients. They lightly suggest that the parents may have misinterpreted the willingness of doctors to administer lethal doses of pain killers.

“I have no doubt that in a small number of cases, some physicians might cooperate with a parent’s desire to see a child’s suffering ended,” Dr. Douglas Diekema, a medical ethicist at Seattle Children’s Hospital, told The Associated Press. “This might include giving a drug for sedation or pain control that also suppresses the drive to breathe.”

“Most physicians don’t intentionally push that drug to the point of stopping a child’s breathing, but some may be comfortable not intervening if a child stops breathing in the course of treating him or her for discomfort,” Diekema said.

The Euthanasia Debate

The debate of euthanasia has hit the status of pop culture with headline catching cases such as Terry Schiavo, Dr. Kevorkian, and the Oregon Legislation for assisted suicide. Internationally, the Netherlands is the only country where euthanasia is legal for infants and children. In all of these cases people had strong opinions, but in the case of a terminal child in pain there may be a little more contemplation.

The researchers in the study promote an open discussion between doctors and parents. They understand that the situation will never be simple and always painful.

The study goes on to suggest that parents and doctors voice their values regarding end-of-life decisions. After interviewing doctors in Oregon, where assisted suicide is legal, the study concluded that “these conversations are highly challenging.”

“Finding an equilibrium between their position and their willingness to relieve patient suffering does not come easily,” the study said.

Tough Decisions that Affect Whole Families

The pain of losing a child can be profound. The image of a child in pain hits the soul at its core empathetic level. The image also highlights a need for what the study calls “progressive thinking” with regard to the choices faced by parents of terminally ill children. They urge open lines of communication from doctors about options for pain relief.

Though the decision is left to parents and doctors as to the care of the child and ultimately what direction the care goes. There are of course exceptions where the state has stepped in. Some highly publicized cases include instances where the parents are refusing care on religious grounds causing their child great pain. Other cases include instances without clear lines of custody.

These are hard medical decisions that require a family to review their legal options particularly if they feel as if the medical practitioner is giving inappropriate advice that may affect the child’s comfort and passing. If you or a loved one find themselves in a situation of a life decision call Phillips Webster for a consultation on your legal options.