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.
AdvertisementThe 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 maintain 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.
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