Medical devices used when performing all surgeries are sometimes made here but often imported and that’s where the government steps in. The Food and Drug Administration is responsible for the regulation of all medical devices used in this country including the ones your cosmetic surgeon uses, no matter if you live in L.A., NYC or Orlando, FL.
The FDA has approved hundreds if not thousands of medical devices over the years used in plastic surgery and liposuction procedures. Every now and again they go back and review, inspect and asses every device they’ve ever approved. How does this affect you, a plastic surgery patient? Here’s how.
The government wants to ensure that all plastic or cosmetic surgery devices like laser instruments, CoolSculpting devices or actual breast augmentation pillows for insertion into the body are indeed safe for use thousands of times each day in the United States. Our welfare is their job and they seem to be doing it. Lately, transparency is a key factor of government agencies and they have started a new program for device approvals that is exactly that: transparent. This keeps manufacturers of medical devices on their toes; sharpening their product safety standards hopefully better than their competitors. As we know, any time a competition breaks out it’s great news for consumers or in this case plastic surgery patients.
What the FDA is doing is important for the general health and welfare of each aesthetic surgery patient in the US. Anything put into our bodies or used inside our bodies must be safe. The agency’s Center for Devices makes sure that companies who make, sell or distribute devices to surgeons across the country adhere to strict safety regulations to achieve this. Examples of regulated devices are any kind of implant, tools for laser surgery, mesh, needles and micro needling tools and so on.
Is this good for plastic surgery in Orlando? Of course. Recently adopted rules and procedures for approval by the FDA take the onus off the government to prove a device is unsafe and turns that around on the manufacturer or seller of the product. If you have a device you want approved by the FDA you now have to show it to them and post-review take their advice on any safety changes that are expected by the government before it hits the market. Prior to this a company would do testing and studies in an attempt to prove it market-worthy, only later to have it be either turned down for approval or pulled from the market. This new system ensures viability of a designed and not yet manufactured product prior to approval as opposed to the previous system of manufacture, then hopefully approval.
This new way of doing things also increases competition among manufacturers to be the first to meet the FDA’s requirements as well as making it the best product that does so. Increased competition on this matter leads to better products overall and that’s great news for both plastic surgeons and patients in Orlando.
The government agency is also learning from reviewing designs for products. They are becoming very savvy about the industry as a whole and what tricks are likely to be tried to get earlier approval, or slink around FDA requested changes.
Making the approval system safer and more efficient for both manufacturers and agency employees saves time and money for everyone. Surgeons and patients win again, here. When product costs for surgeries decrease it’s likely the cost of the procedure itself will remain stable as opposed to getting more expensive each year.
