Previously Approved Medical Devices Skirt Past FDA Evaluation

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May 04, 2012 /24-7PressRelease/ -- Defective hip implant devices and transvaginal mesh devices were put on the market despite significant concerns over the safety of earlier models. And thousands of Americans have been injured as a result. Sadly, a loophole in federal law could be to blame.

By law, the Food and Drug Administration is not required to review or approve medical devices that are "substantially equivalent" to previously approved models, so long as the prior model was not taken off the market pursuant to an FDA or court order. Since the device's prior models were approved, and still available, the law allowed the new devices to skirt past the FDA without evaluation.

However, some regulators are calling on Congress to change this. This past February, the FDA's chief medical-device regulator asked Congress to close this loophole stating that a medical device is five times more likely to be recalled for having safety problems if it is based on an earlier model that had a known design flaw.

His remarks came just weeks after House Democrats introduced a bill that would allow the FDA to reject medical devices if previous models had been subject to manufacturer recalls. The bills' sponsors say the change will go a long way toward protecting patient health and safety.

Medical device manufacturers, however, see the proposal as unnecessary regulation. The Advanced Medical Technology Association, which lobbies on behalf of medical device makers, indicated that the proposed bill "will not contribute to patient safety."

Further, most companies choose to issue a voluntary recall before their products become subject to FDA or court action.

Unsurprising, the bills' sponsors strongly disagree. Each year, on average, the FDA approves 28 medical devices whose design is based on a previously recalled model. Although not all prove to be as dangerous or notorious as the DePuy hip implant or Johnson & Johnson's transvaginal mesh, many still cause serious injuries.

It remains to be seen what actions Congress will take. Additional regulation and red tape may hinder the ability to move medical devices onto the market to help those who need them. On the other hand, without proper evaluation, defective devices could and do prove harmful to consumers they are intended to benefit.

Article provided by Friedman, Hirschen & Miller, LLP
Visit us at www.friedmanhirschen.com

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Previously Approved Medical Devices Skirt Past FDA Evaluation

AppId is over the quota
AppId is over the quota

May 04, 2012 /24-7PressRelease/ -- Defective hip implant devices and transvaginal mesh devices were put on the market despite significant concerns over the safety of earlier models. And thousands of Americans have been injured as a result. Sadly, a loophole in federal law could be to blame.

By law, the Food and Drug Administration is not required to review or approve medical devices that are "substantially equivalent" to previously approved models, so long as the prior model was not taken off the market pursuant to an FDA or court order. Since the device's prior models were approved, and still available, the law allowed the new devices to skirt past the FDA without evaluation.

However, some regulators are calling on Congress to change this. This past February, the FDA's chief medical-device regulator asked Congress to close this loophole stating that a medical device is five times more likely to be recalled for having safety problems if it is based on an earlier model that had a known design flaw.

His remarks came just weeks after House Democrats introduced a bill that would allow the FDA to reject medical devices if previous models had been subject to manufacturer recalls. The bills' sponsors say the change will go a long way toward protecting patient health and safety.

Medical device manufacturers, however, see the proposal as unnecessary regulation. The Advanced Medical Technology Association, which lobbies on behalf of medical device makers, indicated that the proposed bill "will not contribute to patient safety."

Further, most companies choose to issue a voluntary recall before their products become subject to FDA or court action.

Unsurprising, the bills' sponsors strongly disagree. Each year, on average, the FDA approves 28 medical devices whose design is based on a previously recalled model. Although not all prove to be as dangerous or notorious as the DePuy hip implant or Johnson & Johnson's transvaginal mesh, many still cause serious injuries.

It remains to be seen what actions Congress will take. Additional regulation and red tape may hinder the ability to move medical devices onto the market to help those who need them. On the other hand, without proper evaluation, defective devices could and do prove harmful to consumers they are intended to benefit.

Article provided by Friedman, Hirschen & Miller, LLP
Visit us at www.friedmanhirschen.com

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Dr. Grant Stevens Principal Investigator on New FDA Approved Sientra "Gummy Bear Breast Implants"

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Dr. Grant Stevens on New FDA Approved Implants
    MARINA DEL REY, CA, April 21, 2012 /24-7PressRelease/ -- According to Grant Stevens, MD, FACS, a board certified plastic surgeon in private practice in Marina del Rey, CA, and lead investigator on the form-stable silicone gel breast implants also known as "gummy bear breast implants", the new Sientra implants represent the fifth generation of silicone gel augmentation devices. Additional crosslinking between the silicone molecules allows these implants to retain their shape, especially in the vertical position. The Sientra implants were approved recently to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. A total of 355 patients (708 implants) were enrolled prospectively over a 60-month period. Data were collected on patient demographics, implant factors, complications and revisions.

"Innovative breast enhancement techniques are evolving and the Sientra offer yet another alternative to safe breast enhancement," Dr. Stevens says. "Breast augmentation is an extremely popular procedure, and there are a number of ways to personalize the results. Gummy bear implants help women achieve natural looking, long-lasting results." Dr. Stevens coined the term "gummy bear" because of the natural feel and shape this new generation of silicone implants has. Unlike liquid-silicone implants, the gummy bears are made from a cohesive silicone that remains intact, even if cut in half.

Silicone gel-filled breast implants are medical devices implanted under the breast tissue or under the chest muscle for breast augmentation or reconstruction. These implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells.

Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.

"I'm happy that more women are learning about and taking advantage of the advances in plastic surgery techniques," Dr. Stevens says. "With these new implants, it's becoming easier to customize procedures to achieve personalized results."

For more information, visit www.gummybearbreastimplants.com. To make an appointment, visit Marina Plastic Surgery Associates on the web at www.marinaplasticsurgery.com. Follow on Facebook at www.Facebook.com/MarinaPlasticSurgeryAssociates and on Twitter @DrGrantStevens.

Dr. Stevens serves as the medical director of Marina Plastic Surgery Associates in Marina del Rey, CA. He is a Board Certified Diplomate of the American Board of Plastic Surgery and a Fellow of The American College of Surgeons and The International College of Surgeons. Dr. Stevens is the director of the USC Aesthetic Surgery Fellowship and Aesthetic Surgery Division, on the editorial board of The Aesthetic Surgery Journal and on the board of directors of the American Society of Aesthetic Plastic Surgery. An international traveling professor, Dr. Stevens was recognized by his peers as one of America's Best Physicians in "The Guide to Top Doctors." He is past chairman of the California Medical Association Advisory Panel on Plastic Surgery. He has received the Special Congressional Certificate of Recognition and the Distinguished Service Citation from the Medical Board of California.

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Dr. Grant Stevens Principal Investigator on New FDA Approved Sientra "Gummy Bear Breast Implants"

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The remote server returned an unexpected response: (417) Expectation failed.

Dr. Grant Stevens on New FDA Approved Implants
    MARINA DEL REY, CA, April 21, 2012 /24-7PressRelease/ -- According to Grant Stevens, MD, FACS, a board certified plastic surgeon in private practice in Marina del Rey, CA, and lead investigator on the form-stable silicone gel breast implants also known as "gummy bear breast implants", the new Sientra implants represent the fifth generation of silicone gel augmentation devices. Additional crosslinking between the silicone molecules allows these implants to retain their shape, especially in the vertical position. The Sientra implants were approved recently to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. A total of 355 patients (708 implants) were enrolled prospectively over a 60-month period. Data were collected on patient demographics, implant factors, complications and revisions.

"Innovative breast enhancement techniques are evolving and the Sientra offer yet another alternative to safe breast enhancement," Dr. Stevens says. "Breast augmentation is an extremely popular procedure, and there are a number of ways to personalize the results. Gummy bear implants help women achieve natural looking, long-lasting results." Dr. Stevens coined the term "gummy bear" because of the natural feel and shape this new generation of silicone implants has. Unlike liquid-silicone implants, the gummy bears are made from a cohesive silicone that remains intact, even if cut in half.

Silicone gel-filled breast implants are medical devices implanted under the breast tissue or under the chest muscle for breast augmentation or reconstruction. These implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells.

Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.

"I'm happy that more women are learning about and taking advantage of the advances in plastic surgery techniques," Dr. Stevens says. "With these new implants, it's becoming easier to customize procedures to achieve personalized results."

For more information, visit www.gummybearbreastimplants.com. To make an appointment, visit Marina Plastic Surgery Associates on the web at www.marinaplasticsurgery.com. Follow on Facebook at www.Facebook.com/MarinaPlasticSurgeryAssociates and on Twitter @DrGrantStevens.

Dr. Stevens serves as the medical director of Marina Plastic Surgery Associates in Marina del Rey, CA. He is a Board Certified Diplomate of the American Board of Plastic Surgery and a Fellow of The American College of Surgeons and The International College of Surgeons. Dr. Stevens is the director of the USC Aesthetic Surgery Fellowship and Aesthetic Surgery Division, on the editorial board of The Aesthetic Surgery Journal and on the board of directors of the American Society of Aesthetic Plastic Surgery. An international traveling professor, Dr. Stevens was recognized by his peers as one of America's Best Physicians in "The Guide to Top Doctors." He is past chairman of the California Medical Association Advisory Panel on Plastic Surgery. He has received the Special Congressional Certificate of Recognition and the Distinguished Service Citation from the Medical Board of California.

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