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10/20/2017 1:01:18 AM
9/22/2017 12:11:25 AM
Posted: 9/21/2005 2:10:57 PM EDT
[Last Edit: 9/21/2005 2:11:08 PM EDT by Javak]
Silicone Breast Implant Close to Return



WASHINGTON (AP) -- A second manufacturer of silicone gel-filled breast implants moved a step closer to returning the implants to the market Wednesday, when the FDA announced that the company's products can be approved under certain conditions.

The Food and Drug Administration did not detail what conditions were required of Inamed Corp. before its implants would be approved for sale in the United States.

The FDA's finding goes against a recommendation by a government advisory panel last April that Inamed's implants not be approved. The panel, which voted 5-4 against recommending Inamed's implants, cited safety concerns that were not addressed by the company's research.

The FDA said Wednesday that Inamed has subsequently provided additional information to address those concerns.

Inamed also said it would not sell a particular style of implant that had raised particular safety concerns, according to the FDA.

"We respect the thoroughness of the FDA review process and are pleased with this decision," said Nick Teti, president of Inamed, in a statement.

The company said the FDA's conditions were "generally in line with our expectations" but declined to provide details, saying it would work with the FDA on a confidential basis to address them.

However, Amy Allina, program director at the National Women's Health Network, criticized the lack of information describing how Inamed may have addressed safety concerns about the implants.

"A decision like this puts women in a bad spot," she said. "It forces the question, do you trust the FDA or not? At this point we have to say these products do not have appear to have answered the safety questions the agency posed."

In July, another manufacturer, Mentor Corp., cleared the same regulatory hurdle as Inamed did Wednesday. The FDA advisory panel voted in April to recommend approval of the Mentor's application to market the implants, which had been banned because of health concerns.

Proponents who have sought the return of the product say silicone-gel implants look and feel more natural than the salt water-filled implants sold without restriction.

But some women who received them have described silicone oozing out of their bodies and years of pain and other symptoms, which they blame on faulty implants.

Silicone-gel breast implants first went on the market in 1962, before the FDA required proof that all medical devices be safe and effective. They were banned 13 years ago.

The implants largely have been exonerated of concerns that they might cause serious or chronic illnesses such as cancer or lupus. But aside from the risk of breakage, they can cause infection and painful scar tissue.



Will 44 Double-D BOTD thread to follow?
Link Posted: 9/21/2005 2:15:54 PM EDT
One of the guys on my VFD was a medical products rep.

He told me that one of the unexpected results (in pharmacology it's called an Untoward Effect ) of the "ban" on surgical silicone (and the resulting lawsuits) was a 700% jump in the cost of "internal grade" silicone, due to payouts by the makers...

Non cosmetic hings like replacement heart valves, artificial joints and the replacement vertebral disks that were undergoing clinical trials went through the roof... all made of "evil silicone".

IIRC, before the ban surgical silicone sold for $28/lb... after the ban, it was $280/lb...
Link Posted: 9/21/2005 2:16:59 PM EDT
So what are they using now to do implants if its not silicone?
Link Posted: 9/21/2005 2:17:48 PM EDT

Originally Posted By ctprelude:
So what are they using now to do implants if its not silicone?



Saline
Link Posted: 9/21/2005 2:18:28 PM EDT
"Ain't nothing like the real thing baby"

[Forrest Gump]And that's all I got to say 'bout that [/Forrest Gump]
Link Posted: 9/21/2005 2:20:56 PM EDT

Originally Posted By SmilingBandit:

Originally Posted By ctprelude:
So what are they using now to do implants if its not silicone?



Saline



No wonder they taste salty.
Link Posted: 9/21/2005 2:21:40 PM EDT
Link Posted: 9/21/2005 2:23:03 PM EDT
Link Posted: 9/21/2005 2:31:33 PM EDT
[Last Edit: 9/21/2005 2:31:53 PM EDT by xinflt]

Originally Posted By Tango7:
One of the guys on my VFD was a medical products rep.

He told me that one of the unexpected results (in pharmacology it's called an Untoward Effect ) of the "ban" on surgical silicone (and the resulting lawsuits) was a 700% jump in the cost of "internal grade" silicone, due to payouts by the makers...

Non cosmetic hings like replacement heart valves, artificial joints and the replacement vertebral disks that were undergoing clinical trials went through the roof... all made of "evil silicone".

IIRC, before the ban surgical silicone sold for $28/lb... after the ban, it was $280/lb...



So, what evil looking features are included on those pre-ban boobies?
Link Posted: 9/21/2005 2:56:44 PM EDT

Originally Posted By Zaphod:
images.amazon.com/images/P/B00001QGP4.02._SCLZZZZZZZ_.jpg



I'm glad I'm not the only person who expected to be singning "The Bad Touch".
Link Posted: 9/21/2005 2:57:35 PM EDT

Originally Posted By FAIL-SAFE:

Originally Posted By Zaphod:
images.amazon.com/images/P/B00001QGP4.02._SCLZZZZZZZ_.jpg



I'm glad I'm not the only person who expected to be singning "The Bad Touch".





Nope!
Link Posted: 9/21/2005 3:03:39 PM EDT
"Always stroking my own Wookie"
Link Posted: 9/21/2005 9:31:12 PM EDT
worthless with out pictures.
Link Posted: 9/21/2005 9:34:27 PM EDT
Link Posted: 9/21/2005 9:40:53 PM EDT

Originally Posted By subjectofcalifornia:
worthless with out pictures.





Link Posted: 9/21/2005 10:07:42 PM EDT
dude! not only do you have SKELLY as your avitar......but you pull through with the photo's!
Link Posted: 9/21/2005 10:13:06 PM EDT

Originally Posted By xinflt:

Originally Posted By Tango7:
One of the guys on my VFD was a medical products rep.

He told me that one of the unexpected results (in pharmacology it's called an Untoward Effect ) of the "ban" on surgical silicone (and the resulting lawsuits) was a 700% jump in the cost of "internal grade" silicone, due to payouts by the makers...

Non cosmetic hings like replacement heart valves, artificial joints and the replacement vertebral disks that were undergoing clinical trials went through the roof... all made of "evil silicone".

IIRC, before the ban surgical silicone sold for $28/lb... after the ban, it was $280/lb...



So, what evil looking features are included on those pre-ban boobies?


<Feinstein>"More thrusts per squeeze."</Feinstein>
Link Posted: 9/21/2005 10:15:08 PM EDT
[Last Edit: 9/21/2005 10:16:29 PM EDT by MicronuT]

Originally Posted By subjectofcalifornia:
worthless with out pictures.





uhhh... i mean .. installed
Link Posted: 9/21/2005 10:16:35 PM EDT

Originally Posted By Noname:

Originally Posted By subjectofcalifornia:
worthless with out pictures.





www.fda.gov/fdac/graphics/1995graphics/implants2.jpeg



Drool...
Link Posted: 9/21/2005 10:49:18 PM EDT
-OR-

Dear Chasey Lane,
I wrote to explain,
I'm your biggest fan

I just wanted to ask,
Could I eat your a$$
Write back as soon as you can.
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