ultherapy fda patient report

Due to a site consolidation, the mfr reportable event numbers used for submitting fda medwatch forms for ultherapy and cellfina products was updated to use the complaint file (b) (4). It has since been identified that the ulthera (b) (4), should be used for ulthera and cellfina reportable event numbers.

Full Answer

What are the contraindications for Ultherapy?

Ultherapy is contraindicated for the use in patients with open lessions or wounds, cystic acne, existing keloid scarring, mechanical implants, dermal implants, implanted electrical devices, metal implants in the face and anticoagulant treatment plan, pregnant or breast-feeding women.

What is the best use for Ultherapy?

The best use for Ultherapy is as a non surgical brow lift. Ultherapy lifts the brows and opens up the eyes. Ultherapy penetrates the deepest layer of the dermis, sending ultrasound frequency that promotes collagen production.

Is Ultherapy painful?

Without, Ultherapyis can be reasonable painful, particularly towards the end of the treatment. Ultherapy has been featured on Home and Family, Extral, The View, New You, Prevention, NewBeauty, Details, W Magazine and various international programs.

How does Ultherapy compare to Thermage and refirm?

The cost of each Ultherapy treatment is comparable to Thermage and 2-3 times the price of Refirm and Thermage. The results were comparable to Thermage, Refirm and Titan. Ultherapy results were not comparable to injectables or surgery. Ultherapy works differently to conventional lasers that target the outer layers on the skin.

Is Ultherapy FDA-cleared?

Ultherapy is an FDA-cleared non-surgical, non-invasive procedure to treat the face to encourage the natural formation of collagen and elastin in the skin, giving it the ability to lift tissue.

What is the downside of Ultherapy?

The major disadvantages of Ultherapy mostly arise from variations in the technique and skill of the practitioner. There is the danger of a botched procedure: this could result in permanent side effects that could worsen the patient's appearance post-procedure.

Can Ultherapy cause damage?

Following Ultherapy, many patients are reporting nerve damage. Ulthera warns that the procedure may cause muscle weakness, numbness, pain, paresthesia, and tingling that “typically” resolves within 6 weeks. Many patients, however, have reported permanent pain, numbness, tingling, and disfigurement.

Can Ultherapy damage your skin?

Although temporary redness, swelling, and other side effects may occur, the skin itself should not become damaged as a result of Ultherapy. Keep in mind, Ultherapy works by delivering ultrasound waves to the tissue well below the superficial surface of the skin.

Is there anything better than Ultherapy?

Thermage is better for patients who care more about addressing the texture and quality of sagging skin. It has the power to tackle problematic issues like cellulite or drooping fat thanks to its emphasis on contouring. However, Ultherapy is generally more effective when it comes to stimulating deeper skin layers.

What celebrities use Ultherapy?

Jennifer Aniston, Christie Brinkley, Vanessa Williams, and Paulina Porizkova are just a few of the stars who use Ultherapy as their go-to alternative to old-school facelifts. If you've ever wondered how everyone in Hollywood is all endlessly youthful—but still natural—it's probably Ultherapy.

When was Ultherapy FDA approved?

2009In 2009, Ulthera® received its first FDA approval for skin tightening on the face and later received an additional FDA clearance to treat drooping skin on the chin and neck. Earlier in 2014, Ulthera® received its third FDA clearance that allows licensed providers to visualize the dermal and subdermal layers of tissue.

Is Ultherapy safe long term?

Is Ultherapy safe? The FDA-cleared Ultherapy procedure has been used safely in over 350,000 treatments. Ultrasound energy has been used safely in the medical field for more than 30 years.

Does Ultherapy make you age faster?

Collagen is a protein that contains structural fiber that firms the skin and gives elasticity properties. Ulthera slows down the aging process by stimulating collagen production. This helps the skin to maintain a youthful appearance for at least 2 more years. Ultherapy is a natural procedure with very few side effects.

Is Ultherapy better than fillers?

The results of Ultherapy last longer than fillers and patients only need to come in for treatments every 9 to 12 months. Because Ultherapy does not add volume to skin, it is not as successful on its own. Unlike fillers which add volume to the skin, sagging will only be mildly improved with Ultherapy.

What are the pros and cons of Ultherapy?

Ultherapy: Weigh the Pros and Cons of Non-Surgical Skin...Pro: Treatment is Quick. Surgery is a fairly lengthy time commitment. ... Pro: Minimal Discomfort. ... Pro: No Downtime. ... Pro: Results Are Long-Lasting. ... Con: Take Time to See Final Results. ... Con: Not Effective on Significant Sagging.

Is Ultherapy good for jowls?

Ultherapy works best on jowls, chin and lower face that show the signs of mild to moderate laxity. In fact, maintaining your skin with Ultherapy while it has slight to moderate laxity can delay or eliminate the need for cosmetic surgery later.