View Full Version : Are silicone implants safe?



Patrick
04-12-2005, 05:28 PM
The debate rages on. I did a rotation with Dr. Silverstein at Baptist, and he told me that the scare was overblown.

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"Panel Opposes Silicone Breast Implants

By LAURAN NEERGAARD, AP Medical Writer

WASHINGTON - Thirteen years after most silicone-gel breast implants were banned, federal health advisers on Tuesday narrowly rejected a manufacturer's request to bring them back to the U.S. market, citing lingering questions about safety and durability.

Inamed Corp. had argued that today's silicone implants are less likely to break and leak than versions sold years ago. But the Food and Drug Administration was skeptical, and its advisers voted 5-4 that the company hasn't provided enough evidence about how long the implants will last and what happens when they break and ooze silicone into the breast, or beyond.

Without that information, "How can we get an informed consent from our patients?" asked FDA adviser Dr. Amy Newburger, a New York dermatologist. "It makes me very uneasy. ... I don't feel secure about the safety."

That doesn't mean the implants can never be sold, the advisers stressed. No one expects the implants to last a lifetime, but at the very least women need evidence about how likely they are to last 10 years, panelists stressed.

"All of us feel very strongly that women have a choice," said Dr. Barbara Manno of Louisiana State University. But she ultimately opposed lifting the ban because Inamed has tracked patients for only three or four years to check implant durability. She cited concerns that the older the implants get, the more likely they are to rupture.

The decision came after emotional testimony Monday pitting woman against woman: dozens who said implants broke inside their bodies to leave them permanently damaged, and others who want implants they say feel more natural to repair cancer-ravaged breasts or make their breasts bigger.

On Wednesday, Inamed competitor Mentor Corp. will try to change the FDA panel's mind. Mentor is seeking FDA approval of its own silicone implants, but hasn't tracked patients any longer than Inamed did.

The FDA isn't bound by its advisers' recommendations and the panel's vote was a surprise. This same panel, with a few different members, had narrowly recommended allowing Inamed's implants back on the market just 18 months ago, a decision the FDA rejected because of durability concerns.

"Obviously we're disappointed," said Inamed Vice President Dan Cohen, who pledged to work with the FDA to get the necessary additional evidence as soon as possible.

Silicone-gel implants were widely sold in the 1970s and '80s until health concerns prompted the FDA in 1992 to limit their use to women in strict research studies.

The implants have largely been exonerated of causing such serious or chronic illnesses as cancer or lupus. But they can cause side effects, including infection and painful, rocklike scar tissue. Also, they can break, requiring additional surgery to remove or replace them and the FDA and some panelists say questions remain about how often silicone then oozes into the body. The health consequences of such leaks are still in question.

About 14 percent of implants will break within 10 years, Inamed officials told the FDA panel Tuesday, an estimate derived from a study of 940 patients tracked for three or four years.

Just one in 20,000 implants will leak silicone gel beyond the immediate implant area, the company contended. In its study, women whose implants broke reported no more complications than women with intact implants.

Preliminary FDA analyses, in contrast, suggest up to three-quarters of implants will break within a decade.

Why the difference? The FDA assumes that, like many medical devices, as an implant ages it will become more fragile. Inamed's estimate assumes the same percentage of implants will break each year and it blames most of the breakage on surgeon-caused damage at the time of implantation.

That makes no sense, responded FDA adviser Stephen Li, a device-testing expert from Sarasota, Fla. "The odds of creating a series of nicks and cuts ... and it just so happens the same number of them break every year, it's almost fantastic," he said.

But Inamed argued that the salt water-filled implants sold today don't break at a faster rate as they age, and that silicone implants are just as durable. "

mranderson
04-13-2005, 09:30 AM
I am against silicone implants because they usually do not look natural. There is a procedure similar to a skin graph that can be used that uses the tissue from other parts of the body to make the implant. I understand it is totally natural.

I hear saline is also safe, but may not be a natural look.

Leon
04-13-2005, 05:23 PM
If implants were outlawed, only outlaws wuld have implants.

Midtowner
04-13-2005, 05:52 PM
Gotta have the implants.

If it helps a woman's self-esteem, and possibly her career, it's money well spent. In today's world, with the debate having raged on for so many years, it's difficult to believe that a woman would be going into a surgery like this without being apprised of the risks.

Patrick
04-14-2005, 09:22 AM
I am against silicone implants because they usually do not look natural. There is a procedure similar to a skin graph that can be used that uses the tissue from other parts of the body to make the implant. I understand it is totally natural.

I hear saline is also safe, but may not be a natural look.

I'm personally against implants too, but they still should be allowed back on the market. Just because we don't approve of something, doesn't mean it isn't safe.

Patrick
04-14-2005, 09:24 AM
Well, it looks like 1 company will be given the go-ahead to go forward with silicone impants afterall.

"FDA Panel Backs Mentor Silicone Breast Implants

GAITHERSBURG, Md. (Reuters) - A U.S. advisory panel on Wednesday urged approval for Mentor Corp.'s silicone breast implants, a recommendation that could end 13-year-old restrictions sparked by concerns about the health risks when silicone leaks.

The 7-2 endorsement from the Food and Drug Administration advisory panel was a surprise following the committee's 5-4 rejection a day earlier of Inamed Corp.'s silicone implants.

"They're not the same device," said panel member Stephen Li, president of Medical Device Testing and Innovations, noting that Mentor's implants had an "extremely low rupture rate" and impressive testing on device fatigue.

"The statistics and the follow-up were excellent, and we didn't have nearly the questions on this application as we did on (Inamed's)," Li said.

Mentor shares rose 12 percent in after-hours trading, while Inamed shares fell 5 percent.

The FDA will consider the panel's input as it decides whether to approve more widespread use of silicone implants. Concerns about potential links between leaking silicone and disabling diseases prompted officials to ban the devices for most women in 1992.

The agency typically follows its panels' advice, but 15 months ago it overruled a recommendation for approval of an earlier Inamed bid for silicone breast implants.

Final FDA approval of Mentor's implants "is by no means a slam dunk. ... The end result won't be known for some time," said Amit Hazan, an analyst at SunTrust Robinson Humphrey.

If the FDA decides to approve Mentor's application, the company should monitor some women for implant ruptures for 10 years and meet other conditions, the panel said. Also, women considering implants should get consent forms detailing what is, and what is not, known about implant risks.

Many women and plastic surgeons say silicone implants look and feel more natural than saline breast implants -- the only option for most U.S. women since 1992.

Implant makers also say today's silicone implants are more durable than older versions, and the gel is stickier and less likely to migrate.

Studies have failed to find a connection between silicone implants and rheumatoid arthritis, lupus and other chronic diseases that many women tie to the devices.

But panel member Brent Blumenstein said he was concerned that some women studied by Mentor reported exhaustion, joint pain and other possible symptoms of chronic diseases.

"In short, there's too much uncertainty," he said.
Makers admit implants can cause pain and other local complications, and they can break and require new operations to replace them. Mentor said a study of about 400 women showed 1 percent of implants broke over three years. None of the ruptures caused problems, and were detected by MRI scans. Other research showed no ruptures before seven years, Mentor said.

The ruling in favor of Mentor was a shock to rival Inamed, said Dan Cohen, Inamed's vice president of global government and corporate affairs.

"I am stunned and amazed by the bizarre decision by a small number of panel members who yesterday demanded longer-term data and today accepted shorter-term data," Cohen said.

Inamed's main study followed patients for three to four years, while Mentor's main study tracked women for two to three years.

In the United States, only breast cancer survivors and others needing reconstruction or implant replacements can now receive silicone implants, through clinical trials.

After closing up 2.2 percent to $35.33 in regular trading on the New York Stock Exchange, Mentor shares gained 12 percent to $39.45 a share on the Inet electronic brokerage.

Inamed shares, which closed down 4.4 percent at $63.51 on Nasdaq, fell 5 percent to $60.30 after hours on Inet. Inamed is being acquired by Medicis Pharmaceutical Corp. . "

Midtowner
04-14-2005, 03:08 PM
I'm personally against implants too, but they still should be allowed back on the market. Just because we don't approve of something, doesn't mean it isn't safe.

I'm starting to think you're more libertarian than liberal.

Patrick
04-15-2005, 01:01 AM
I'm starting to think you're more libertarian than liberal.

Probably, but explain. I'd be interested to learn more about the libertarian party, and why you think I fit!

Midtowner
04-15-2005, 11:22 AM
Probably, but explain. I'd be interested to learn more about the libertarian party, and why you think I fit!

Sorry, don't want to hijack the thread ;)

We were talking about the fake breasts, weren't we?

Now that is a subject that I never thought I could be distracted away from :)

Leon
04-15-2005, 01:26 PM
Fake breast = Women of Mass Distraction

asta2
04-20-2005, 09:02 AM
Gotta have the implants.

If it helps a woman's self-esteem, and possibly her career, it's money well spent. In today's world, with the debate having raged on for so many years, it's difficult to believe that a woman would be going into a surgery like this without being apprised of the risks.

And what possible career would a woman have that breast implants would help other than swim suit model or porn star? I'm not against them but I think they are pointless. I can understand a women who is completely flat chested but honestly they make most women just look top heavy. I'm fairly small and small chested. I got a good look at myself with big boobs when I was breastfeeding. (something hard to do with implants that young women don't take into consideration). Nothing fit right and they got in the way of everything. I just can't imagine those things when your 70 and your boobs and cement hard. Nasty!

Ms.Relaxationstation
04-21-2005, 09:54 AM
Gotta have the implants.

If it helps a woman's self-esteem, and possibly her career, it's money well spent.

Hey a Ferari and a college education might help her in those ways too. lol Although implants ARE cheaper...lol Thank God for my natural FAT.
:LolLolLol

Patrick
04-22-2005, 02:12 PM
And what possible career would a woman have that breast implants would help other than swim suit model or porn star? I'm not against them but I think they are pointless. I can understand a women who is completely flat chested but honestly they make most women just look top heavy. I'm fairly small and small chested. I got a good look at myself with big boobs when I was breastfeeding. (something hard to do with implants that young women don't take into consideration). Nothing fit right and they got in the way of everything. I just can't imagine those things when your 70 and your boobs and cement hard. Nasty!

Well, I think the media gives us a bad impression of implants.

Actually, implants can be look quite natural and add a lot to a woman's appearance, especially if she's flat chested....that is, if it's done right.

I did a rotation with Dr. Silverstein, a plastic surgeon here in NW OKC that uses silicone breast impants.......when he did impants, he never increased the size of the breasts more than a C cup. Obviously, anything larger than that would be overkill and look fake. Most of the patients I saw for follow-ups had pretty natural looking breasts. You would've never known they had implants.