Navigation Links
FDA gives the green signal for silicone breast implants

After decades of controversy, the US Food and Drug Administration have lifted a 14 year ban on the commercial use of silicone breast implants. //Allergan Inc of Irvine and Mentor Corporation of Santa Barbara, California have been authorized to market the implants to women over 22 years of age. The earlier rules stipulated usage only for research purposes.

In 1992 the FDA ordered the stoppage of sales of silicone implants citing lack of clinical data to garner support for marketing approval. As per Dr Daniel Shultz, Director of FDA's Center for Devices and Radiological Health, accumulation of clinical and non clinical data over the years has resulted in the change in policy by FDA.

The conclusions are based on a thorough review by the FDA on the core studies conducted by Allergan and Mentor. The companies will be required to continue their studies for another 10 years and manufacture the implants according the stringent quality regulations laid down by the FDA. The risks are also required to be stated on the product labels. Dr Shultz also warns that breast implants are unlikely to be lifetime devices and recipients may require undergoing more breast implant surgeries during their lifetime.

Dr Donna Bea-Tillman, Director of FDA's Office of Device Evaluation stated that the decision was reached after careful consideration of the potential risks against the benefits. Satisfaction over the implants far outweighed the occasional reports of complications like pain and hardening of the breasts, implant rupture and even the need for further corrective surgery. The possibility of cancer or disease of connective tissue was ruled out based on reports by Institute of Medicine.

However Dr Sydney Wolfe of the Public Citizen opined that saline implants still remained a safer option. Saline implants have much lesser complications on account of leaks and reduced rate of ruptures. The Public Citizen has strongly criticized the approval. They main tain that the approval for silicone implants smacks of double standards especially as FDA is yet to approve silicone testicular implants citing inadequacy of clinical trials.
MST
'"/>




Related medicine news :

1. Microchip gives blind a chance of sight
2. Microchip gives blind a chance of sight
3. Combined scan gives exact cancer diagnosis
4. Tennis gives protection against heart disease lifelong
5. Camera gives hope for detection of breast cancer
6. Pancreas transplant gives hope to type 2 diabetes
7. FDA gives “black box warning” against three asthma drus
8. Trust in Doctor gives better cure
9. Wonder drug Dasatinib gives hopes to leukemia patients
10. 5 Year Old Paralyzed Victim Forgives 50 Year Old Man Who Shot Her
11. ‘Aricept’ drug gives an Alzheimer’s patient reason to smle
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:1/13/2017)... ... 13, 2017 , ... People with type 2 diabetes know ... easy as checking the nutrition label on foods for grams of sugar. But ... sugar-free, proteins can influence — either positively or negatively — insulin secretion and ...
(Date:1/13/2017)... ... January 13, 2017 , ... A January 10 article ... 2017 according to the publication, with an emphasis on some new techniques that the ... F.A.C.S., who is known more casually to his patients and colleagues as Dr. J, ...
(Date:1/13/2017)... ... , ... With the increasing public preference for chemical-free personal ... alternatives for customers who have grown more conscious about maintaining their health and ... charcoal products, Moody Zook Chief Executive Officer Nate Ginsburg explained their company’s decision ...
(Date:1/13/2017)... ... 2017 , ... An inventor from Virginia Beach, Va., is always on the ... diversify my outfits, so he decided to design something that enhances the look of ... of a belt to allow for quick, easy changing of its look. This not ...
(Date:1/13/2017)... ... , ... "We wanted to create a design for orthodontic appliances that would ... Virginia Beach, Va. , They created a prototype for the patent-pending BRACE FACERS to ... to be customized to suit personal tastes. They can be used to create custom ...
Breaking Medicine News(10 mins):
(Date:1/15/2017)... , January 16, 2017 Der ... Kollagenprodukten für die Regeneration des menschlichen Gewebes, gibt die ... mit sofortiger Wirkung bekannt. ... Bill Allan ... Er bekleidete eine Reihe von Geschäftsführer- und anderen Führungspositionen ...
(Date:1/13/2017)... Eli Lilly and Company (NYSE: ... ) announced today that the U.S. Food and Drug ... new drug application (NDA) for investigational baricitinib, a once-daily ... rheumatoid arthritis (RA). The NDA for baricitinib was submitted ... FDA extended the action date to allow time to ...
(Date:1/13/2017)... , Jan. 13, 2017 Wichita Laser ... cutting-edge laser treatments to Wichita, Kansas ... provides advanced treatments for skin rejuvenation, getting rid of ... lesions and vascular lesions. "Since being in ... in Wichita for laser tattoo ...
Breaking Medicine Technology: