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:6/27/2016)... ... June 27, 2016 , ... TopConsumerReviews.com recently awarded their highest five-star ... , Millions of individuals in the United States and Canada wear eyeglasses. Once considered ... both correct vision and make a fashion statement. Even celebrities use glasses as a ...
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified ... be personalized through a fitness app. The fitness app plans to fix the two major ... only offer a one size fits all type program , They don’t eliminate ...
(Date:6/25/2016)... Viejo, California (PRWEB) , ... June 25, 2016 , ... ... to fit their specific project," said Christina Austin - CEO of Pixel Film Studios. ... fully customizable and all within Final Cut Pro X . Simply select a ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, ... the latter, setting the bar too high can result in disappointment, perhaps even self-loathing. ... toward their goal. , Research from PsychTests.com reveals that behind the ...
(Date:6/24/2016)... ... 2016 , ... The Pulmonary Hypertension Association (PHA) learned during ... two significant new grants to support its work to advance research and patient ... recognizing patients, medical professionals and scientists for their work in fighting pulmonary hypertension ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)...  Arkis BioSciences, a leading innovator in the ... cerebrospinal fluid treatments, today announced it has secured ... led by Innova Memphis, followed by Angel Capital ... Arkis, new financing will accelerate the commercialization of ... of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... , June 23, 2016 Any dentist who has ... of the current process. Many of them do not even ... technical difficulties and high laboratory costs involved. And those who ... it at such a high cost that the majority of ... Dr. Parsa Zadeh , founder of Dental Evolutions ...
(Date:6/23/2016)... , June 23, 2016 Roche (SIX: RO, ... clearance for its Elecsys BRAHMS PCT (procalcitonin) assay as ... or septic shock. With this clearance, Roche is the ... fully integrated solution for sepsis risk assessment and management. ... bacterial infection and PCT levels in blood can aid ...
Breaking Medicine Technology: