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.
Did you know that you can use your social media connections to keep your
loved ones safe and informed about liposuction risks and regulations?
By sharing this page on Facebook, Twitter and Google Plus, you can help
victims of liposuction malpractice get the help they need. See the media
icons on this page? Simply click them to instantly share this page with
your friends and family.