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FRAXEL WARNING

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FRAXEL WARNING

Postby walker942 » Fri Mar 27, 2009 9:38 pm

Watch our story or see photos on realself

http://cbs3.com/video/?cid=220

Facing the pain


Note: This is an old post. The link above resolves to a commercial followed by the WEATHER forecast.
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Postby DCNGA » Sat Mar 28, 2009 7:37 am

Thank you for having the courage to do this story, Walker942. Surely, your story will save others this type of devastation and pain (physical and emotional). I hope things improve for you.

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Postby Confused1 » Sat Mar 28, 2009 10:38 am

Now, I am more than a little confused. Anyone who has researched Fraxel should be aware of Christine's case. I had always assumed she was talking about Fraxel Repair because Repair is Ablative and Restore is non-ablative. After watching the video, and hearing about the $900 price tag and the talk of quick recovery, I now assume Christine had Fraxel Restore. Restore and Repair are like apples and oranges, and Fraxel did a disservice to customers by creating such similar names. I investigated RESTORE when it came out and considered it ineffective for what I wanted to accomplish. I have had Fraxel REPAIR done twice at 70mj-60% settings(about as high as it goes), with no problems, and good results for the treatment of acne scars. I am planning a third REPAIR in November because it takes 2-4 treatments for acne scars to achieve optimum results. Before people have any laser procecure they need to do serious research, and understand what type of laser they are using. The 2 major Fraxel Laers are as different as night and day.
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Postby DCNGA » Sat Mar 28, 2009 2:22 pm

Walker is on realself.com. You can read her entire story there, along with many more pictures. Just go to the reviews on "fraxel" and you can find her story quite easily.

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Postby Confused1 » Sat Mar 28, 2009 7:03 pm

DCNGA, OK, I think I have this figured out. The TV show as usual gave some misinformation that threw me off when they said the women paid $900 for the procedure. Christine's case with Fraxel Repair is quite famous, and I was on Realself when she began posting the problem. As far as I know doctors have never figured out what went wrong with her procedure. It appears Walker had her problems with the unrelated Fraxel Restore. Although everyone considering a laser procedure needs to evalulate possible complications it makes no sense to lump all lasers under one umbrella.
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Postby DCNGA » Sun Mar 29, 2009 7:07 am

But, you cannot also assume that one laser is GOOD for everyone. I wish I could figure out why some lasers work for some people and some people can use no lasers. What may work perfectly for you, even using the same doctor, might be a disaster for me.

The process for approval of these and other medical devices is a terrible disgrace and needs to be addressed. I'm hoping the current Congress will do that this year. It's got to be bad when the FDAs own scientists are writing to Congress and saying things must change within the FDA or people's health and lives are at stake. Their comments were aimed at medical device approval in general, not lasers--but the same applies.

I'm glad you had a great outcome. The point (IMHO) is the next person may not. Horror stories abound and it's all very sad.

Take care.

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Postby Confused1 » Sun Mar 29, 2009 8:33 am

DCNGA, it frightens me when Congress does anything but go on reccess. They are not doctors, anymore than Oprah Winfrey is, and I would prefer if matters stay in the hands of the FDA. We just endured 8 years of a president who was anti-science, and we don't need lawyers dispensing medical advice. I believe congress is totally incapable of rendering any rational decision.
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Postby DCNGA » Sun Mar 29, 2009 11:53 am

Ummmm...the people asking CONGRESS to fix the problems with the FDA are FDA scientists, not lawyers actually. This has been all over the news and was brought to light last year by the PEOPLE WORKING AT THE FDA. I, myself, have very little trust in the FDA at this moment, based on what people who work for the FDA are claiming. The first letter was blacked out for the protection of those reporting the problems at the FDA. Originally, their names were announced, but later the letter had the names blacked out. This is from a US government website:

http://energycommerce.house.gov/Press_1 ... ntists.pdf

http://energycommerce.house.gov/Press_1 ... h.CDRH.pdf

Nine scientists at the Food and Drug Administration have written a letter to President-elect Barack Obama and his transition team, alleging gross mismanagement at the agency that has "placed the American public at risk."

Excerpts from the letter sent to then, president-elect Obama and members of Congress:

"The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk."

Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts. Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid.

Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around."


Maybe my research can benefit you somewhat in broadening your knowledge on the subejct. The laws/approval process that governs the medical devices referenced in the next link also governs cosmetic lasers. Heck, these devices even had a higher level of clearance/approval attached to them, than cosmetic lasers and people still died:

http://www.nytimes.com/2008/02/21/washi ... .html?_r=1

From The MN Star Tribune By JANET MOORE, Star Tribune
Last update: December 10, 2008 - 8:51 PM

“A prominent Minneapolis cardiologist, writing in this week's edition of the New England Journal of Medicine, is questioning whether a next-generation heart defibrillator in development by several Minnesota companies will be sufficiently tested for safety before its U.S. launch.

Dr. Robert Hauser of the Minneapolis Heart Institute Foundation said in the Dec. 11 edition of the medical journal that the novel technology could expose patients to potentially lethal risks if it is not rigorously tested in humans before being approved by federal regulators.

"The consequences for the patient could be catastrophic," Hauser said in an article he wrote with the Heart Institute's Dr. Adrian Almquist.


http://www.pharmalot.com/2008/11/congre ... approvals/


Great article on how medical devices are approved and why it is flawed:

http://www.dcwderm.com/arch.pdf

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Postby Confused1 » Sun Mar 29, 2009 7:02 pm

I could post link after link about congressional corruption, but it would get tedious. I am not arguing that problems exist at the FDA, but I am questioning congresses ability to correct another body when it stands as a totally corrupt organization. I don't want this to turn into a political forum, lord knows I already debate on those.
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Postby cbray88 » Mon Mar 30, 2009 5:55 pm

I have to agree with confused on this one. The segment is confusing. I'm aware of both cases and if I'm correct, Christine was able to get some help for her "fraxel repair scars" by geting "fraxel restore" treatments. Walker's issues were created by the fraxel restore. It's not that I don't feel deeply for both ladies as I had my own set of issues with Fraxel Repair, I just think the news segment should have been a little more clear.
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Postby Confused1 » Mon Mar 30, 2009 6:55 pm

cbray, I totally agree, and I believe anybody considering either of these procedures needs to be aware of these 2 cases, but they are not the same cases, nor the same laser. I feel that if I don't offer the counterpoint to the original statement that many people who might have been helped by Fraxel Repair will seek other less effective treatments.
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Re: FRAXEL WARNING

Postby Ameeme » Thu Sep 05, 2013 12:22 am

I had an amazing experience with fraxel! Read my full review with pictures of before and after on my blog.. www.ameeme.wordpress dot com
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Re: FRAXEL WARNING

Postby Confused1 » Sun Sep 15, 2013 8:27 am

Ameeme wrote:I had an amazing experience with fraxel! Read my full review with pictures of before and after on my blog.. http://www.ameeme.wordpress dot com



I am happy to hear of your experience. Most people do have a good experience.
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Re: FRAXEL WARNING

Postby Confused1 » Sun Sep 15, 2013 8:29 am

Ameeme wrote:I had an amazing experience with fraxel! Read my full review with pictures of before and after on my blog.. http://www.ameeme.wordpress dot com


Congratulations on your experience. The vast majority of people do have good experiences with Re:pair.
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