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Archive : July, 2011

New FDA approved product for Nasolabial folds…

Wednesday, July 20th, 2011

There is now a new option recently approved by the FDA for nasolabial folds.  But don’t hold your breath, it may still be afew years before its wisely available, read on:

 The US Food and Drug Administration (FDA) approved the first autologous aesthetic cell therapy to improve the appearance of moderate to severe nasolabial fold wrinkles in adults. The product, azficel-T (laVív), is from Fibrocell Science, Inc, a company focused on developing personalized cell therapies for aesthetic, medical, and scientific applications.

According to the company, creating azficel-T involves a patented technology whereby fibroblasts are extracted from behind the patient’s ear and sent to the Fibrocell Science laboratory, where they are multiplied for about 3 months and then frozen until needed.

 
Azficel-T (laVív). Fibrocell Science Inc

Over a series of 3 treatment sessions, typically 3 to 6 weeks apart, they are injected into nasolabial folds to reduce the appearance of smile lines.
The company says the therapy will become available gradually through trained clinical investigators in select metropolitan areas. As manufacturing capacity is increased and more physicians trained, the number of cities served will expand as well.

The product will be mostly administered by dermatologists and plastic surgeons; only physicians who complete a Fibrocell-approved training program will be able to administer it.

The training program teaches proper biopsy collection and shipment procedures, treatment preparation and injection technique, and logistics tracking to ensure that the cells received by each patient are derived from that same patient.

“Revolutionary” Approach
“The concept of using a patient’s own collagen-making cells is a revolutionary way to help treat nasolabial fold wrinkles and help restore a fresh appearance,” Robert A. Weiss, MD, clinical associate professor, Johns Hopkins School of Medicine, Baltimore, and director of the Maryland Laser Skin and Vein Institute, Hunt Valley, noted in a company-issued statement.

“Since this is a biological process that works over time, [azficel-T] is able to provide gradual and natural-looking results,” noted Dr. Weiss, who participated in clinical trials of azficel-T.

 
A patient’s nasolabial fold wrinkles before (left) and after (right) azficel-T treatment. Fibrocell Science Inc

This approach is “likely appeal to patients who want to take a very new approach to treating wrinkles,” Stacy Smith, MD, associate clinical professor in the Division of Dermatology at the University of California–San Diego, who also worked on azficel-T clinical trials, said in a statement.

“By injecting tens of millions of the person’s own fibroblasts, patients now have the option to help smooth smile lines by adding cells to replace those that may have been lost through the aging process,” he added.
Babak Azizzadeh, MD, FACS, director of the Center for Advanced Facial Plastic Surgery and assistant clinical professor of facial plastic surgery at University of California–Los Angeles, commented, “It’s an interesting and novel approach that will generate some excitement among physicians and some patients.

“But at the end of the day,” he told Medscape Medical News, “it’s going to depend on whether the results are better than with off-the-shelf injectables, such as Juvederm (Allergan), Restylane (HA North American Sales AB), and Sculptra (Sanofi-Aventis), which are the main competition.”

Dr. Azizzadeh was not involved in the studies of azficel-T and has not treated any patients with it.  He added that “a limiting factor is that the patients have to have a biopsy and then wait 3 months before they get their injections, and then they have to go through a series of treatments. It’s a long process. Physician acceptability, with the length of time involved, may also be an issue.”

2 Pivotal Clinical Trials
The FDA approval was based largely on 2 identical phase 3 multicenter, randomized, double-blind, placebo-controlled studies involving 421 patients who underwent 3 treatment sessions approximately 5 weeks apart.
On the basis of investigators’ and patients’ assessments, a significantly greater proportion of patients demonstrated a positive response to treatment with azficel-T than with placebo, the company notes. The treatment improved the appearance of nasolabial fold wrinkles for the 6 months of patient follow-up after the last treatment. The company said studies are ongoing, looking at how long beyond 6 months after the last treatment the effect may last.

In clinical trials, azficel-T was well tolerated, according to the company. The most common adverse events were mild to moderate injection-site reactions that usually resolved within 1 week. As part of a postmarketing requirement, Fibrocell will set up a registry of approximately 2700 patients to further evaluate the safety of this autologous cell therapy.

More news on Silicone Breast Implants…

Thursday, July 7th, 2011

 More news from the FDA about silicone breast implants. Fat grafting to the breast is sounding better and better.  I go for training and certification this week:

Silicone gel–filled breast implants are safe and effective when used according to their labeling, but the longer a woman has the implants, the more likely she is to experience complications, the US Food and Drug Administration (FDA) said in a new report released on June 22, 2011.

“Breast implants are not lifetime devices,” Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said during a telephone news conference. “One in 5 patients who received implants for breast augmentation will need them removed within 10 years of implantation. For patients who received implants for breast reconstruction, as many as half will require removal 10 years after implantation.”

Women with silicone breast implants will need to monitor their breasts for the rest of their lives. To screen for silent ruptures, women should undergo magnetic resonance imaging 3 years after implantation, and then every 2 years thereafter, Dr. Shuren said. Women with saline implants do not need regular imaging.

When the FDA allowed silicone breast implants back on the market in November 2006, it required manufacturers to conduct follow-up studies to learn more about the long-term performance and safety of the devices. The FDA’s report is based on preliminary safety data from these studies, as well as other safety information from recent scientific publications and adverse events reported to the agency. The most frequently observed complications and adverse outcomes are tightening of the area around the implant (capsular contracture), additional surgeries, and implant removal. Other complications include a tear or hole in the outer shell (implant rupture), wrinkling, uneven appearance (asymmetry), scarring, pain, and infection. Studies to date do not indicate that silicone breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis, the FDA said. However, no study has been large enough or lasted long enough to completely rule out these and other rare complications. “Most women report high levels of satisfaction” with their implants, Dr. Shuren said.

The FDA is working with the 2 manufacturers who make silicone breast implants, Allergan and Mentor, to address the challenges in collecting follow-up data on the women who have received these implants. Approximately 5 to 10 million women worldwide have breast implants. In the United States, 296,203 breast augmentation procedures and 93,083 breast reconstruction procedures were performed last year, according to the American Society of Plastic Surgeons. About half the procedures used saline implants, and half used silicone implants. Patients with either saline or silicone implants may have a very small risk for a rare cancer called anaplastic large-cell lymphoma (ALCL) adjacent to the implant. However, the risk is “profoundly small,” said Dr. Shuren. “Since 1997, there are only 34 cases in the published literature, and at most 60 cases out of the 5 to 10 million women with implants worldwide,” he said. “We don’t yet know if there is a causal link.”

When the FDA first released information about the risk in January, William Maisel, MD, MPH, chief scientist and deputy director for science in the FDA’s Center for Devices and Radiologic Health, said the evidence suggests that the kind of ALCL found in conjunction with breast implants is less aggressive and is sometimes treatable by simply removing the implant, the capsule, and the collected fluid. “The FDA will continue to monitor and collect safety and performance information on silicone gel–filled breast implants, but it is important that women with breast implants see their healthcare providers if they experience any symptoms,” Dr. Shuren said. “Women who have enrolled in studies should continue to participate so that we may better understand the long-term performance of these implants and identify any potential problems.” The FDA is holding an expert advisory panel in the next few months to discuss how postapproval studies on breast implants can be more effective. The FDA will issue an update at a future date on saline implants, Dr. Maisel said. All serious adverse effects should be reported to the breast implant manufacturer and Medwatch, the FDA’s safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

-Rafael C. Cabrera, MD, ,FACS