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FDA Approves Natrelle 410 Breast Implant

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Silicone gel-filled breast implants Image/FDA

Silicone gel-filled breast implants
Image/FDA

Feb. 20, 2013

The U.S. Food and Drug Administration (FDA) approved Allergan’s  new silicone gel-filled breast implant today, making it the fourth FDA-approved silicone gel-filled breast implant product available in the U.S, according to an FDA news release Feb. 20.

Silicone gel-filled breast implants Image/FDA

The product, the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant, can be used increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.

According to the FDA, the approval is based on seven years of data from 941 women. Most complications and outcomes reflect those found in previous breast implant studies including tightening of the area around the implant (capsular contracture), re-operation, implant removal, an uneven appearance (asymmetry), and infection.

It’s important to remember that breast implants are not lifetime devices. Women should fully understand the risks associated with breast implants before considering augmentation or reconstruction surgery, and they should recognize that long-term monitoring is essential,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

“The data we reviewed showed a reasonable assurance of safety and effectiveness,” said Shuren.

The FDA requires that Allergan conduct a series of post-approval studies to assess long-term safety and effectiveness outcomes and the risks of rare disease.


2 Comments

  1. seara says:

    My daughter aftre california screening has cobalamin c defecinecy it is rare i was told 200 cases maybe i am looking for someone in same exsperiance to corasponed with

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DR ANTHONY CRASTO

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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