This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

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

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, 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
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!

Markets

DOW 18,030.21 +6.04 0.03%
S&P 500 2,081.88 -0.29 -0.01%
NASDAQ 4,773.4720 +8.0480 0.17%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs