Medicis Aesthetics, the manufacturer of Restylane, announced on October 11 that Restylane has now received FDA approval to be used for lip augmentation. Although Restylane has been used extensively for lip augmentation, doing so was considered an off-label indication. Restylane, a hyaluronic acid dermal filler, was first approved in 2005 for mid to deep dermal injection for the correction of moderate to severe facial wrinkles and folds, and has been used off-label for lip augmentation.
An FDA advisory panel had previously voted 6-0 with 1 abstention that the benefits of using Restylane as an injection for lip augmentation outweighed its risks, and that the filler was safe and effective for this indication. The panel reviewed the results of a study of 135 patients who received Restylane and 45 patients with no treatment. Almost all patients (99%) experienced adverse events, which included bruising, redness, swelling, pain, tenderness, itching, and skin exfoliation. Of those who were treated, 15% experienced adverse events (typically swelling and tenderness) that lasted more than 15 days.
Restylane and Juvederm are the most commonly utilized hyaluronic acid fillers in the United States. To learn more about treatments with Restylane and Juvederm, contact Dr. Jejurikar’s office at Dallas Plastic Surgery Institute at 214-827-2814.
Women with large breasts (macromastia) often suffer significant pain and discomfort from their large breasts. Dallas breast reduction is an effective treatment for symptoms related to large breasts. In addition to providing physical comfort, Dallas breast reduction can also improve the appearance of the breasts by performing a simultaneous breast lift.
Symptoms of macromastia often include severe neck, shoulder and upper back pain, painful grooves from their bra straps, and rashes, wounds and infections (intertrigo) within the folds of their breasts. Although Dallas breast reduction has been demonstrated to alleviate symptoms associated with large breasts and improve quality-of-life, the amount of tissue required for excision to provide medical benefit has yet to be demonstrated. It is not uncommon for me to believe that a Dallas breast reduction will help my patient, only to have the patient’s insurance company disagree.
Breast reduction surgery is considered by the American Society of Plastic Surgeons to be medically necessary when symptoms of back pain, neck pain, shoulder pain, intertrigo, breast pain, and numbness of the extremities are documented and related to the patient’s large breasts. The recommendations of the ASPS are based on outcomes studies that essentially demonstrate no correlation between amount of breast tissue excised and relief of preoperative symptoms. Unfortunately, when symptoms are self-reported and subjective, it is difficult to determine medical necessity as, often, breast reduction is a cosmetic procedure. As a result insurance companies usually require extensive documentation of symptoms, as well clinical notes documenting failure of conservative treatment, including supportive bras, NSAIDs such as ibuprofen, physical therapy and chiropractic treatments. In addition, most insurance companies have a minimum tissue excision requirement that must be met to demonstrate medical necessity for Dallas breast reduction surgery.
If you’d like to learn more about Dallas breast reduction surgery, contact Dr. Jejurikar’s office at 214-827-2814 or via the Web.
I’ve always been proud to be a member of Dallas Plastic Surgery Institute and am happy to announce that we now have a Web Site providing a general view of our group, as well the services and facilities we offer our patients. To learn more about Dallas Plastic Surgery Institute, visit dpsi.org.