The Food and Drug Administration (FDA) is an extremely important federal agency that provides regulatory testing research in order to protect the citizens and animals of this country. The agency is responsible for protecting public health by assuring the safety, adequacy, and security of human (and veterinary) drugs, biological products, medical devices, food supply, cosmetics, and radioactive products. It is also responsible for helping to expedite medical innovations that will make medicines more effective, safer, and more affordable.
Unfortunately, despite the efforts of the FDA, certain medical equipment and drugs can pass inspection even though they’re not 100% safe due to limited regulatory powers.
Liposuction Regulation Cans and Cannots of the FDA
When it comes to medical supplies, equipment, and drugs for liposuction procedures, the FDA has certain rules that control what it can and can’t regulate.
What it can regulate:
- The sale of medical devices and drugs.This includes syringes, scalpels, pumps, collecting containers, ultrasound probes, and cannula (the vacuum apparatus that is used to suck the fat out), If a device isn’t approved by the FDA, it is illegal by federal law to be used by physicians.
- Safety designs and manufacturing of equipment and drugs. In order to gain approval from the FDA, the manufacturer must present evidence that the device is reasonably safe and effective for a particular use. Once a device is approved, other similar devices may be cleared by the FDA without substantial evidence of safety, since an equivalent device has already been shown to be safe and effective.
- Registration of medical equipment for use. Once a device or drug has been approved by the FDA, it will receive a proper registration in order for it to legally be allowed for commercial use.
What it can’t regulate:
- A doctor's practice. Although the FDA can monitor equipment, it can’t tell doctors how to use that equipment, what to do when running their business, or what they can or cannot tell their patients about the equipment and procedure.
- Liposuction cost.The FDA has no control over how much a doctor can charge for his services.
- Sharing of information. It has no control over whether a doctor chooses to provide patient information to a potential patient.
- Performance of doctors who perform liposuction. Since the FDA doesn’t maintain a list of doctors who practice liposuction, it can’t monitor individual personnel who show consistent signs of negligence or carelessness.
- Devices or equipment similar to approved designs. Although it keeps records of individual prototypes, the FDA doesn't require all individual types of equipment to be extensively researched. For example, if a certain type of probe is signed off on, than any other designs that are similar to that probe don’t have to be seen or examined as thoroughly by the FDA.
FDA Violations and Protecting Yourself from the Consequences of a Faulty Device
The FDA’s safety tests for liposuction equipment are generally done in small groups and problems can be missed during an investigation. This is why it is important to report adverse reactions or other problems with FDA-regulated products, to your FDA Consumer Complaint Coordinator at 410-779-5713. If these reactions have caused you serious harm you may be eligible for compensation. Contact us today for a free consultation and review of your injury case. We’ll be happy to discuss your patient rights and determine if malpractice was committed.
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