TVAM Procedure Lawsuit

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 What is a TVAM Procedure? Are There Any Risks Involved?

TVAM, is the acronym for “transvacuolar autonomic modulation.” Commonly used as a treatment for coronary artery disease, it has recently been promoted as a way of treating the symptoms of neurological diseases such as Parkinson’s disease, multiple sclerosis, and other conditions.

Originally, the TVAM procedure was a type of angioplasty. This is a procedure that has been used to clear blocked arteries. For example, a coronary angioplasty is a common procedure used to treat narrowing of the coronary arteries, or arteries of the heart, that cause coronary heart disease and create the risk of heart attack.

The TVAM procedure has been used to open arteries that feed other organs in the body, such as the carotid artery in the neck. However, the TVAM procedure has been promoted by doctors for use in the jugular vein in order to treat neurological diseases. Promoters describe it as insertion of the balloon into the jugular vein in the neck. The balloon is then inflated and this accomplishes stretching of the vein.

While the balloon is stretching the vein, manual compression is applied externally. Or, hands, presumably those of a doctor or surgeon, compress the skin over the inflated vein. Supposedly, in some manner, proponents claim that this maneuver “maximizes the physical energy delivered to the autonomic nerve fibers that travel within the outer tissues of the jugular vein.” In this manner, again, according to proponents of this off-label use of the procedure, the autonomic nervous system of the body is “reinvigorated” through improvement of the “communication” between the organs and the brain.

This use of TVAM is a so-called “off-label” use. An off-label use is a use that is not the one for which the procedure is intended, prescribed and approved by the Food and Drug Administration (FDA). Off-label uses are more common with prescription medications. The FDA approves medications to treat certain health conditions. When a doctor prescribes a medication off-label, they prescribe it for a different condition or at a different dosage than the FDA has approved.

At least one U.S. physician has claimed that the procedure treats autonomic dysfunction in a number of neurological disorders. However, the FDA has issued a safety alert regarding TVAM for use in treating autonomic dysfunction. The FDA reports that it has not reviewed any data that supports the safety and effectiveness of balloon angioplasty devices for this intended use.

The FDA believes that performing a TVAM procedure using these medical devices poses a risk to patients because the safety and effectiveness of using balloon angioplasty devices in a patient’s venous system has not been established scientifically for treating any kind of medical condition. The FDA has approved these devices for use mostly in arteries.

Furthermore, it may be associated with serious health risks such as:

  • Stroke;
  • Blood clots;
  • Cranial nerve damage;
  • Abdominal bleeding; and/or
  • Various other conditions.

In some cases, injuries from TVAM procedures have been fatal.

There is no clear scientific evidence to support the claim that the treatment of internal jugular venous stenosis is safe in any patient. The description of how the procedure “reinvigorates” the ANS is vague and without scientific substance.

The autonomic nervous system (ANS) controls several basic physiological functions, including the following:

  • Heart rate;
  • Body temperature;
  • Breathing rate;
  • Digestion;
  • Sensory perception, e.g. hearing, vision, touch.

A person does not control these functions through conscious thought and effort. The ANS provides the connection between the brain and certain body parts, including the body’s internal organs. For example, the autonomic system connects a person’s heart, liver, skin, and even the interior muscles of the eyes.

When the nerves of the ANS are damaged, autonomic dysfunction develops. This condition is known as “autonomic neuropathy,” or “dysautonomia.” Autonomic dysfunction can lead to mild symptoms or those that are life-threatening. It can affect only part of the ANS; it can affect the entire ANS. Sometimes the symptoms of ANS are only temporary and reversible. And sometimes they can become chronic and long term. They may worsen with the passage of time.

As noted above, Type I Diabetes and Parkinson’s disease are two kinds of chronic conditions that can lead to autonomic dysfunction.

The TVAM procedure has been used in the U.S. and elsewhere to treat multiple sclerosis (MS). Multiple sclerosis is a condition in which destruction of the protective coating of nerve fibers disrupts signals from the brain, causing problems with walking, vision, speech and memory.

Canadian researchers at the University of British Columbia and Vancouver Coastal Health tested the TVAM procedure as a treatment for MS in 104 MS patients. In the report of their research and its results, they stated that a year after having the treatment, the patients who got the treatment were no better than a group that got a sham treatment.

In 2017, reportedly, the FDA took action against a physician, after having warned him at least twice since 2012 that he was performing the TVAM procedure, which it considers experimental, on patients without the approval required to conduct a clinical trial. It should be noted that when doctors perform procedures of this type, they charge thousands of dollars and profit greatly from it.

Who Can Be Held Liable for Injuries Caused by a TVAM Procedure?

Injuries from a TVAM procedure, recovery from the procedure or its side effects can have many different causes. Depending on the circumstances, different parties may potentially be liable for damages. Parties that might be liable could include the following:

  • Healthcare Professionals: Doctors, surgeons, and other healthcare professionals who have committed medical malpractice in connection with a TVAM procedure or other similar surgical procedure;
  • Manufacturers of Medical Equipment: Manufacturers and distributors of medical equipment can be held liable under a strict product liability theory if a defect in their product causes an injury to a patient. An example of this would be a situation in which a defect in the balloon component of the TVAM equipment causes the balloon component to rupture, resulting in injury to the patient;
  • Nurses and Hospital Personnel: Nurses, other medical staff and personnel in a hospital can also be held liable for medical malpractice, if their negligence contributes to causing an injury to a patient receiving a TMVA procedure.

Are There Any Legal Remedies for TVAM Procedure Injuries?

Injuries sustained during a TVAM procedure can be serious. A victim may have to file a civil lawsuit if the evidence shows that either medical malpractice or a defective medical device caused their injuries.

Civil cases for both medical malpractice and strict product liability seek compensation for the losses suffered by the victim in the form of an award of monetary damages. The healthcare provider whose malpractice caused the victim’s injury or the manufacturer and distributor of the defective medical device that caused injury, or their insurance companies, would pay the award.

The damages should compensate the victim for all costs associated with treatment of their injuries, such as hospital and doctor bills, medication, and anything else that was required to return the victim to good health. If the victim has lost time from work, their lost wages should be compensated as well. In addition, monetary compensation for the victim’s pain and suffering could be an element of their damage award. In a few cases, the facts might justify an award of punitive damages also.

If the victim has not been returned to good health at the time their case is settled or goes to trial, then they could recover damages for the projected cost of future care and future lost wages. If they have lost earning capacity permanently, this too would be compensated.

There may be other consequences from these cases as well. For example, if a physician or other healthcare provider has committed malpractice, they may be sanctioned by their respective licensing agencies.

If a person’s injuries from a TVAM procedure should be fatal, then their close family members would file a lawsuit for wrongful death.

Do I Need a Lawyer for Help with a TVAM Injury Lawsuit?

TVAM procedure lawsuits and other related claims can be serious. It would be in your best interest to consult an experienced personal injury lawyer in your area if you believe that you have been injured in the course of a TVAM procedure.

Your attorney can analyze the facts of your case and determine whether medical negligence or a product defect caused your injuries. Your lawyer can advise you how best to proceed in order to recover compensation for the losses your injury has caused.

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