This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Inamed Gains FDA Nod

The Food and Drug Administration has overruled an advisory committee by granting conditional approval to Inamed (IMDC) to sell silicone gel breast implants for cosmetic surgery.

If the agency ultimately approves the Inamed product, the Santa Barbara, Calif.-based company will join Mentor (MNT), its next-door neighbor and rival, in selling these implants.

Mentor received conditional FDA approval in late July, but neither the company nor the FDA described the conditions or the timetable for meeting the conditions.

U.S. sales of silicone gel implants have been restricted since 1992 to a few uses, such as for women undergoing breast reconstruction after mastectomies and women whose silicone gel implants had ruptured. The restrictions reflect tougher FDA requirements that manufacturers provide long-term safety data to support applications for their devices.

The FDA's announcement on Wednesday sent Inamed's stock rising $5.96, or 8.4%, to $77.02, a new 52-week high. In the first two hours of trading, more than 3.44 million shares were traded, or nine times the average daily trade for the last three months. Mentor's stock fell $2.38, or 4.5%, to $50.18 in heavy trading.

The FDA offered no details about the conditions or timetable for approving Inamed's implant. "The conditions outlined in this letter are generally in line with our expectations and the discussions that took place at [previous] FDA advisory panel meetings, and we look forward to working with the agency ... in addressing them," said Nick Teti, Inamed's chief executive officer.

The FDA noted that an advisory committee voted 5-4 in April against Inamed's silicone gel implant application. "Since then, Inamed has provided FDA with additional information to address the primary safety concerns discussed by the panel," the agency said Wednesday. The FDA said Inamed will no longer make a certain implant that had raised safety concerns among panel members.
1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
IMDC $0.00 0.00%
AAPL $93.74 0.00%
FB $117.58 0.00%
GOOG $693.01 0.00%
TSLA $240.76 0.00%


Chart of I:DJI
DOW 17,773.64 -57.12 -0.32%
S&P 500 2,065.30 -10.51 -0.51%
NASDAQ 4,775.3580 -29.9330 -0.62%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs