Navigation Links
Breast Augmentation – FDA Approves New Silicone Gel Implant
Date:6/22/2013

Los Angeles, CA (PRWEB) June 22, 2013

According to a June 14, 2013 NBC News report, titled “FDA Approves Mentor's New Silicone Gel Breast Implant,” the FDA has approved the Mentor MemoryShape Breast Implant, making it the fifth silicone implant to receive such approval in the United States. Though the approval comes with strict stipulations for monitoring patients, the FDA found the implant to be safe for use in breast augmentation and reconstruction. They did, however, require that the manufacturer commit to extensive additional testing and continued monitoring of the original test group (go to goo.gl/DX4vp).

“The approval of the MemoryShape breast implant means women now have another choice for their breast augmentation or reconstruction,” says Dr. Simon Ourian, Medical Director of Epione Beverly Hills.

According to the report, the FDA determined that women have a "reasonable" expectation of safety and that the side effects from the MemoryShape implant were similar to those experienced with other implants. These problems included hardening of the skin around the implants causing them to be encapsulated, an uneven appearance, and cracking. These complications are not unusual for any of the FDA approved silicone devices.

Further according to the NBC report, the FDA has required that Mentor carefully monitor the women in the study for an additional 10 years. Also, the company must monitor another 350 women who will receive a type of MemoryShape device for five full years. The FDA has further stipulated that Mentor study 2,500 additional women who get MemoryShape implants for ten years to watch for long-term problems. As another safeguard, Mentor must perform five control studies involving 10,750 women to watch for an association with diseases that include brain and cervical cancer.

“The testing before approval was extensive and the continued testing and monitoring required of Mentor by the FDA is strict and quite large in scope,” says Dr. Ourian, “reflecting the FDA's concern for possible links between implants and rare diseases.”

Dr. Ourian has been a pioneer in laser technology and non-invasive aesthetic procedures including Restylane, Juvéderm, Radiesse and Sculptra. These treatments are used for the correction or reversal of a variety of conditions such as acne, acne scars, skin discoloration, wrinkles, stretch marks, varicose veins, cellulite, and others. More information about silicone breast implants can be found on Epione’s website

Read the full story at http://www.prweb.com/releases/2013/6/prweb10859542.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related medicine news :

1. New Trends in Venezuela Raise Awareness of Breast-Feeding Benefits
2. Mercy Takes Leadership Role in Use of Medical Technology, Offering IORT for Breast Cancer Patients and New National Institute of Robotic Surgery at Mercy
3. Third Generation California Vintner Cheryl Indelicato Makes Strides in the Fight Against Breast Cancer
4. FDA Approved Mentor® MemoryShape™ Breast Implants Now Offered to Patients at Swan Center for Plastic Surgery
5. EORTC study opens for elderly patients with HER-2 positive metastatic breast cancer
6. Internationally Acclaimed Breast Augmentation Expert Announces the Launch of His New Website
7. Fat cells in breast may connect social stress to triple-negative breast cancer
8. Osteoporosis drug may help treat advanced hormone-sensitive breast cancer
9. Abnormalities in new molecular pathway may increase breast cancer risk
10. U.S. Supreme Court Invalidates Patents on Breast and Ovarian Cancer Genes
11. Protein protects against breast cancer recurrence in animal model
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/24/2017)... ... January 24, 2017 , ... ... of a new report from the Frank Hawkins Kenan Institute of Private ... business leaders, academics and policy makers identified concrete solutions at the “What’s Next, ...
(Date:1/24/2017)... ... January 24, 2017 , ... The results from the ... and particularly good news for prostate cancer patients: incidents of cancer is down as ... the report the cancer death rate has dropped from its peak of 215.1 in ...
(Date:1/24/2017)... ... January 24, 2017 , ... American Family Care (AFC) has opened a new ... care for residents in the area. The Bedford clinic will be the nineteenth location ... years by Dave Adams and Dr. Kristina Orio. Adams and Orio also independently own ...
(Date:1/24/2017)... Overland Park, KS (PRWEB) , ... January 24, ... ... rating to Premensa, a leading natural supplement for relieving premenstrual syndrome, or ... premenstrual syndrome at some point. These symptoms can include cramps, constipation, irritability, headaches, ...
(Date:1/24/2017)... ... 2017 , ... “Who Would Have Dreamed: A Novel of Miracles”: a beautiful and poignant ... understand its purpose in her life. “Who Would Have Dreamed: A Novel of Miracles” is ... love of writing. , Sharon shares that she started her spiritual journey later ...
Breaking Medicine News(10 mins):
(Date:1/24/2017)... Market Research Future has a half cooked research report on Global Wound ... and expected to continue its growth by the end of 2022. ... Wound Closure ... 2019 and reaching a value of 13 billion by 2019 and 21 ... Wound Closure Device Market has been growing rapidly and is expected to ...
(Date:1/24/2017)... , Jan. 24, 2017 Market Research Future has a ... Market. The global market for Plastic Surgery & Integumentary System is ... end of the forecasted period. Market Highlights ... Global Plastic Surgery & Integumentary ... predicted that the market will reach high growth figures and thriving ...
(Date:1/24/2017)... 2017 Research and Markets has announced the ... - Product, Material - Forecast to 2025" report to their ... The ... CAGR of around 5.4% over the next decade to reach approximately ... that the market is witnessing include 3D medical printing is expected ...
Breaking Medicine Technology: