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:12/2/2016)... ... December 02, 2016 , ... U.S. Surgeon General, Dr. ... Mediaplanet, Dr. Murthy explains how he was inspired to practice medicine at an early ... medicine is about more than making diagnoses and prescribing medicine,” he states. “It is ...
(Date:12/2/2016)... (PRWEB) , ... December 02, 2016 , ... ... inspirational interview of two ostomy patients, standing as living proof that attitude and ... from digestive diseases and issues that spike around the holidays. This campaign will ...
(Date:12/2/2016)... ... , ... More than half of American teens report losing their virginity before ... their child about sex related topics, less than 60 percent spoke about deeper themes ... the launch of its second edition of the “Sexual Wellness” campaign, aiming to address ...
(Date:12/2/2016)... (PRWEB) , ... December 02, 2016 , ... ... a new version of its SaaS LIMS, CloudLIMS Lite. CloudLIMS Lite helps biobanks, ... entry through labeling, storing, shipping and disposal. The new version is a faster ...
(Date:12/2/2016)... ... December 02, 2016 , ... Universal Medical Systems, Inc. ... the first company to offer robotic imaging to veterinary medicine is sponsoring the ... 941 for the American Association of Equine Practitioners 62nd Annual Convention from December ...
Breaking Medicine News(10 mins):
(Date:12/2/2016)... December 2, 2016 Orthopedic Implants (Including ... is Expected to Gain a Significant Market Share Owing to ... ... According to a new report ... Implants Sterile Packaging: Clamshell Product Type Segment Projected to Witness ...
(Date:12/2/2016)... Dec. 2, 2016   CytoSorbents Corporation (NASDAQ: ... its European Union approved CytoSorb ® cytokine adsorber ... patients worldwide, announced that Dr. Phillip Chan , ... Annual LD Micro Main Event investor conference held ... the Luxe Sunset Boulevard Hotel in Los ...
(Date:12/2/2016)... 2, 2016 On Thursday, the NASDAQ ... Dow Jones Industrial Average edged 0.36% higher, to finish at ... Losses were broad based as six out of nine sectors ... reports on the following Services equities: Myriad Genetics Inc. (NASDAQ: ... ), INC Research Holdings Inc. (NASDAQ: INCR ), ...
Breaking Medicine Technology: