Recently, the U.S. Food and Drug Administration released a warning on the use of unapproved fat dissolving injections, which can turn out to be harmful. What does this show? The rising popularity of fat-dissolving injections as a non-invasive alternative for fat reduction has led to a concerning trend: the proliferation of unapproved products in the market.
The recent surge in people falling for these fat dissolving injections available online and from non-licensed weight loss clinics and the adverse event reports have made the FDA issue warning on these weight loss drugs.
Fat Dissolving Injections- The Lure of a Quick Fix
What are fat dissolving injections? These are also called lipolysis injections or injection lipolysis, which are used to trim down the fat in specific regions such as chin, hip, thigh, abdomen or buttocks.
Fat dissolving injections, often marketed as a revolutionary non-surgical alternative, pledge to tackle stubborn pockets of fat resistant to diet and exercise. These injections typically contain substances that target and break down fat cells, promoting a smoother, more contoured appearance.
The allure of fat dissolving injections lies in their promise of rapid results without the need for surgery. This non-invasive approach appeals to individuals seeking a quicker path to achieving a more sculpted physique, when compared to surgical procedures.
Unlike surgical methods, people can get their desired slim and toned body with lesser hospital stay and recovery time.
Do not think that one or two doses of injections can offer you the desired outcome. These injections can work on only a small region of fat and so multiple injections are needed to treat a single area like abdomen or thigh.
However, the outcome doesn’t come at once. To see the changes you expect, you need to wait for 6 to 8 weeks.
How long does fat dissolving injections last? Once the fat cells are removed, you can’t be relieved. Only by following a healthy life style, diet and exercise, you can maintain the result you have got and prevent gaining weight again.
Popular Types of Fat Dissolving Injections
Many types of fat dissolving injections are available at the present. Are these fat-dissolving drugs FDA approved? No. Not all these drugs are FDA approved. Is there any FDA approved fat dissolving injections? Yes, Kybella is FDA-approved.
Kybella
Kybella from Allergan Aesthetics, is approved to break down the fat cells in the submental area (double chin issue) in adults. Though it is not approved to treat other body parts, professionals use them to treat fat in other regions too.
Kybella consists of a compound called deoxycholic acid, which is naturally found in bile fluid secreted in the liver to digest lipids (fat) in the small intestine. With deoxycholic acid, the fat cells just shrink but if the person gain weight again, these fat cells can expand in size.
Aqualyx
Aqualyx from Marllor Biomedical is another popular fat dissolving injection available online. It is made of a compound called desoxycholan-acid to dissolve fat, commonly used for body contouring. Aqualyx fat dissolving injections are not approved by the FDA.
Lemon Bottle
SID MEDICOS’ Lemon Bottle Fat Dissolving Injection is another fat dissolving injection produced by a Korean company. As it is classified as a cosmetic product, it does not fall under FDA regulations. It consists of ingredients such as bromelain, riboflavin and lecithin.
Kabelline
Kabelline injection (a cytolytic injection) is manufactured by Dexlevo Inc. It is a face and body contouring serum. Though claimed to use the FDA-approved component deoxycholic acid, it has not received the FDA approval. Kabelline side effects include dysphagia, nausea, hypertension, oropharyngeal pain, hardened skin, redness, swelling, etc.
Lipo Lab
A South Korean company, CSBIO Inc., manufactures Lip Lab. The main ingredient is purified PPC sodium deoxycholate. Rare lipo lab side effects includes lightheadedness, tender nodules, pain, pigmentation, and ulceration in patients.
Lipodissolve
Lipodissolve is made with phosphatidylcholine (PC) and deoxycholate (DC) and is not FDA approved in the US. Due to a lack of standardized manufacturing, it is also banned or highly regulated in other many countries.
The common fat dissolving injections ingredients in most of these products named phosphatidylcholine (PPC) and sodium deoxycholate (DC) were not tested for safety or effectiveness or approved for use by the FDA. Some common lipodissolve side effects are pain, soreness, swelling, bruising, inflammation and changes in skin texture.
Are fat dissolving injections safe?
The safety of fat dissolving injections other than Kybella are not evaluated by the FDA. Moreover, research studies on the safety and efficacy of these fat dissolve injections are not available yet. Therefore, these fat melters can cause potential side effects.
Backdrop of the FDA Warning
On December 20, 2023, the FDA issued a consumer warning on the potential side effects from the use of unapproved fat dissolving injections available online. The FDA informed that the fat burning injections that are being sold online under names like Aqualyx, Kabelline, Lipo Lab, Lipodissolve and other such injections are not approved by the FDA. As the FDA has not evaluated the safety and efficacy of these injections for weight loss, they may pose significant health issues.
The FDA has received adverse event reports from the consumers who used these injections. The incidents report issues like serious skin infections, permanent scars, skin deformities, cyst or painful knots forming under the skin after the administration of these fat dissolving injections. Even some med spas and weight loss clinics without proper license are administering these injections. Another growing trend noted by the FDA was the consumers getting the unapproved drugs online and injecting themselves.
Along with the adverse lipolysis injections side effects, unsafe and improper injection practices also could heighten the risk of injuries. Only experienced professionals would know the proper methods of injecting fat melting injections on the right spot, in right dosages, with proper needle placement. People’s extreme quest for weight loss encourages unlicensed people to start clinics and give weight loss treatment for costs lower than the professionals. This attracts people fall a prey like moths to a flame.
The FDA had noted the case of a woman whose fat dissolving injections gone wrong. She encountered injuries from Lipodissolve fat dissolving injections. She had “developed infected knots on both arms one week after receiving unapproved fat-dissolving injections.”
This is not the first time, the FDA has issued warning on fat dissolving injections. In 2010, the FDA had issued warning letters to around a half-dozen spas including Monarch Med Spa of King of Prussia, Pa., Pure Med Spa of Boca Raton, Fla., and three others, which treated people with Lipodissolve injections. They used Lipodissolve to treat fat deposits around arms, belly and legs.
Fat Dissolving Injections Side Effects
The lipolysis injections side effects pose serious risks to human health. The common side effects include:
- Rashes or redness at the treatment site will last for at least 24 hours.
- Bruising will be present for around 48 hours.
- Numbness at the injection site may last in around a month.
- Pain and discomfort last for at least a day.
- Edema or swelling can be seen for 1 to 2 days.
- Hardening of the treated area can last for around 60 days.
The known and possible side effects as seen in the label warning of the FDA-approved Kybella injection are as follows:
Still wish to get fat burning injections? Consider the following:
If planning to get fat dissolving injections, it is better to get consultations with qualified and licensed medical practitioners such as dermatologists or plastic surgeons. They will have experience and insights on the safety and efficacy of available fat removal injections. This could assist people in making informed decisions aligning with their cosmetic expectations and overall well-being after weighing the pros and cons of fat dissolving injections.
What to do if affected by the fat dissolving injections?
In case of facing adverse side effects from the fat reduction treatment using unapproved drugs, seek medical treatment without delay and report them to FDA’s MedWatch program. As most of these kinds of injections come under cosmetic procedures, they are not approved by the FDA.
Aside from medical help, you can take legal actions against these products by pursuing a product liability lawsuit to seek compensation for damages. These cases typically involve complex legal and medical issues, emphasizing the importance of engaging experienced attorneys who specialize in product liability law.
To initiate a lawsuit, it’s crucial to first establish the nature and extent of the harm caused by these unapproved fat dissolve injections. Victims may suffer from a range of severe health issues, including permanent scarring, infections, skin deformities, or other significant adverse side effects as a direct result of receiving these injections. Gathering comprehensive medical documentation and evidence of the harm suffered is a critical first step. This process involves consulting with medical professionals who can attest to the injuries’ causation and extent.
The legal process then moves to filing a claim against the parties responsible for manufacturing, distributing, or administering the unapproved fat-dissolving injections. This stage often involves intricate negotiations with the defendants and their insurance companies to reach a settlement that adequately compensates the victim for their injuries. Should these negotiations fail to yield a satisfactory outcome, the case may escalate to a trial, where the evidence will be presented before a judge or jury.
Representation by skilled attorneys is indispensable throughout this process. Such legal professionals bring a depth of knowledge in product liability law, enabling them to effectively advocate on behalf of victims. They can handle the legal intricacies, negotiate with opposing parties, and, if necessary, present a compelling case in court.
Eligible victims can get reparation for the following damages:
- Medical expenses
- Pain and suffering
- Lost income
- Punitive damages
Role of Medical Record Review in Fat Dissolving Injection Claims
To ensure compensation, the fat dissolving injection injury should be substantiated through vital evidence. The medical records of the victim can play a crucial role in that. A thorough medical record review can easily locate the negligence in the manufacturing of the injections, procedure errors of the clinic or professional who treated the victim, the extent of injury, expenses incurred and the pain and suffering undergone by the victim.
Another key aspect of the medical legal claim is to establish the causation of the harm. The victim has to prove that the administration of the fat dissolving injections has directly caused harm to the victim. The crucial correlation between the injection and the adverse side effects can be established by analyzing the types of the components of the injection, the dosages used and the techniques used to administer the injections.
If the negligence of the provider caused the injuries, a record reviewer can examine the qualifications and experience of the provider and identify if the techniques used are appropriate and standard. Any negligence in the administration or follow up care can bolster the claim.
Apart from the physical injuries, a medical record review can assess the emotional distress sustained by the victim due to the permanent scarring, disfigurement and the pain and suffering from the fat dissolving treatment. It can also calculate the expenses incurred and the potential future medical expenses pertaining to the fat dissolving injections.
LezDo TechMed provides expert medical record reviews in product liability claims. Reach out to get precise record reviews to boost your claims.
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To conclude,
The desire to get a slim and toned body is not wrong. But trying for short cuts will always end up in distress. Looking for cheaper options, risking one’s health do not worth the suffering one has to endure. Seeking the help of medical professionals will ensure healthy and safer options. Taking informed decisions in choosing the best-suited fat dissolving injections or other methods can save people from unnecessary legal tangles.
In case of injuries, do not hesitate to get legal counsel to fight for justice.
Be informed and be safe!
