MAUDE Adverse Event Database-File A Complaint If You Have Been Harmed By A Cosmetic Medical Device

For those who do not know, the FDA maintains a database for reporting adverse events from the use of any medical device, including cosmetic medical devices. This database is called MAUDE (Manufacturer and User Facility Device Experience). Although this is a terribly flawed system, it is a cosmetic device victim's only means of reporting these FDA approved devices to federal authorities. As it is now, the manufacturers fill out reports themselves and investigate themselves. Sadly, doctors/facilities rarely report adverse events as they should. I would imagine out of fear of a lawsuit or being ignored by the FDA. Nonetheless according to the Archives of Dermatology/VOL 142, FEB 2006" editorial (www.dcwderm.com/arch.pdf)

"it is estimated that only1%-2% of reportable events actually get reported..."

It is important to file an adverse event report if you have been harmed. Once you are on the first page of the form, you can skip this page if you do not wish to leave your information, although it is protected by the HIPPA law. You can file a complaint here:

Click "Begin" Button at This Link To File A Complaint

You may also file an adverse event report by:

telephone at 1-800-FDA-1088

fax at 1-800-FDA-0178

mail to:

MedWatch
The FDA Safety Information and Adverse Event Reporting Program
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20852-9787

From the MedWatch Website:

"MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, such as drugs and medical devices.

If you think you or someone in your family has experienced a serious reaction to a medical product, you are encouraged to take the reporting form to your doctor. Your health care provider can provide clinical information based on your medical record that can help FDA evaluate your report.


However, we understand that for a variety of reasons, you may not wish to have the form filled out by your health care provider, or your health care provider may choose not to complete the form. Your health care provider is NOT required to report to the FDA. In these situations, you may complete the Online Reporting Form yourself.


You will receive an acknowledgement from FDA after your report is received. You will be personally contacted only if we need additional information.

What the FDA requires regarding Adverse Events from manufacturers:

"Adverse event reporting enables FDA to take corrective action on problem devices and to prevent injury and death by alerting the public when potentially hazardous devices are discovered. Within FDA, the Center for Devices and Radiological Health (CDRH) is responsible for regulating medical devices.


Regulations require device manufacturers to report to FDA (1) within 30 calendar days of acquiring information that reasonably suggests one of their devices may have caused or contributed to a death, serious injury, or malfunction and (2) within 5 working days if an event requires action other than routine maintenance or service to prevent a public health issue. Regulations also require user facilities, such as hospitals and nursing homes, to report deaths to both the manufacturer, if known, and FDA within 10 working days. User facilities must report serious injuries to the manufacturers (or FDA if the manufacturer is unknown) within 10 working days. User facilities must also submit annual reports to FDA of all adverse event reports sent to manufacturers or FDA in the past year.

"Overall, FDA received twice as many adverse event reports for medical devices in 2007 than in 2003; however, some types of reports decreased. Manufacturers, user facilities, and other reporters submitted 72,866 medical device adverse event reports in 2003, which doubled to 150,210 reports in 2007. Manufacturers submitted the vast majority of these reports. Thirty-day reports of death, serious injury, and malfunction accounted for almost all manufacturer reports and drove the overall increase in adverse event reports."

Visit this link to see the adverse event reports filed from 2002-10/2010 regarding cosmetic devices detailing hundreds of adverse events surrounding these devices.

Lucille Iacovelli

If you have never heard her name then you've probably never researched plastic surgery.

I "met" Lucille several years ago on an Internet forum.  She was posting of the evils of having plastic surgery. We corresponded off and on for several years. While I was not in total agreement with Lucille that all plastic surgery was evil, I always agreed that the way she was treated by the medical community was evil. The harm done to her is beyond the comprehension of most of us. It would take hours to tell her heartbreaking story.

Lucille died on August 2, 2010. She was steadfast in telling her truth, an indomitable spirit. She joined our support forum in late June and posted our blog and forum URL on to her blog. I will do the same for her here today. The posts on our forum were amongst some of the last she left on the Internet.

She spoke her truth. She did what her heart said to do. She did not buckle under and stayed true to herself until the end.

May you have the peace in death that you were not given for the last 10 years, Lucille.

http://www.losingface.net/

Stories From Our Support Board

Below is a story from one of our IPL and Laser Damage Support Board members. I have posted this with her permission:

I unfortunately want to document here, on the IPL and Laser Damage blog, that I have suffered more than just fat loss from IPL. I have suffered nerve/muscle damage as well. I trusted this FDA approved machine, administered by a board certified doctor to correct acne scars and stop hair growth on my chin and upper lip. My face was mutilated and my life permanently altered by this device, which I was told and assured was safe, non-invasive.

Whether it be said or proved how many people are being affected or damaged from these devices, each individual life counts and this damage should not be minimized by doctors, the manufacturers or the FDA. The public has the right to know possible side affects that these devices cause before they receive the treatments. Patients are not being told.

Doctors insisted it was impossible for Thermage to melt fat, which was later proven, and now legally must warn patients beforehand. Doctors will tell you it is not possible for fat loss to occur with the IPL, but that is not true. I am proof that it does happen, it happened to me. If you want to trust the  information provided by doctors performing IPL and using other cosmetic devices then do so at your own risk.

The FDA is not enforcing further research or testing to prove our damage, so there is no proof out there that is required to reveal it is happening,other than the stories like mine and so many others on our support board and all over the Internet.  Many have and will continue to be harmed, as long as those affected are dismissed or not heard. It's sad. My intention, please just know, is to make you aware that it is happening and of the possibility that it can happen to you as well. Slim or not, decide if the risk is worth it to you.

If you are reading this and have already been harmed by IPL or other lasers please report it to Erin Brockovich's site, she has a link under "product liability" on her website to collect the data of those harmed. Also, for much more helpful information, insight and support from others harmed and places to go to receive help if damaged, please come to the IPL and Laser Damage support forum to talk more in depth. It is a safe place to help support each other through this and has helped me personally, a great deal.

This laser did not stop after melting through my fat, it kept going...burning from my insides out. I say to any doctor who disagrees. Receive the same treatment as myself, same settings, same temp, same areas and then we can talk from equal experience.

The bottom line is...these lasers and cosmetic devices are penetrating deeper then those who are administering them and selling the treatments claim. Unfortunately until the amount of those harmed proves and outweighs, the false claims, it can and will continue. Please be counted and consider at least joining the The IPL Laser Damage Support forum or writing Erin B so that you, as an individual, can be counted and help prove this damage is occurring. The more stories accumulated in one place, the easier it will be to prove this is happening to many people.

Peace

PSA COSMETIC DEVICES.wmv

IPL and Laser Damage Support Board

Our support board has moved to the following URL:

http://iplandlaserdamagesupport.prophpbb.com

Please visit to read the stories of those damaged by government approved cosmetic devices at:

http://iplandlaserdamagesupport.prophpbb.com/

The Damage Continues

The support board continues to have new members, almost weekly. I wish I could say we never have new members and that no one else has been harmed by IPL, Fraxel and other cosmetic devices, but that is not the case. We've saved a few the fate so many have suffered and some have found the support board too late. Doctors still refuse to believe the reports of the support board members, even though most of the stories are eerily the same, if not identical.

We have a new board. Please visit us at:

http://iplandlaserdamagesupport.prophpbb.com/

Link to board (click here)

CNN was considering a story regarding the damage from these devices, but don't know that it will ever come to fruition. There is also another company representative from a red light device maker who has shown interest in helping those harmed by cosmetic medical devices.

If somehow you stumble across this blog and know of a researcher or anyone who has an open mind or might be willing to read the stories posted or help those harmed by these devices, please let me know or point them to the IPL and Laser Damage Support Board where they can read the stories themselves.

In Memoriam: Angela Walker (AWalk)

Angela Walker was a young woman from Virginia who went in for a simple "Fraxel" treatment and came away damaged for life. She was extremely brave and exposed her pain and suffering for the world to see on realself.com, in hundreds of posts and with pictures of her devastating facial damage. Angela was a beautiful person, inside and out.

You may read her entire story here (in her own words):

http://www.realself.com/review/do-not-do-fraxel-ruined-face-burns

This is Angela's first post from realself:

"Do not let anyone put this laser on your face...I was burned and haven't felt comfortable leaving my home in over a year......At first you may think its ok and you're healing...but the laser goes so deep the real results show later.....NOT PRETTY....

The B/After pics aren't that impressive and its very new...

Stick with tried and true I had better results with peels....

510k FDA is not FDA approved or safe......only says other lasers like it on market.....Don't fall for it....It's all marketing and hype....

WAIT till it's been around longer and they work out the kinks and know how to use it....

Will upload pics later

Updated on Jan 25, 2009:
I had this procedure 2 years ago at a plastic surgeons office who I’ve seen for 9 years for botox resty….I would not recommend it to my worst enemy… It seems you may have improvement at first but it causes DNA damage to the existing cells not destroyed..The negative results damage may not be apparent for months or years…..There is not enough research it was put to market to soon and we are the guinni pigs……Don’t let this laser on your face…They have treatments available with long term studies on all skin types that doctors have more experience using…

Updated on Feb 4, 2009:

To the company, executives and sales reps, who rushed this laser to market before they did correct and responsible studies. Exploited the system ..Your unscrupulous, irresponsible, marketing, advertising, and buying of doctors is inexcusable.

You are the true criminals of society not drug addicts, burglars, adults abused as children or the mentally ill that fill our prisons… You have options yet choose to in danger others for personal gain…

You should know I cry everyday and every time I look in the mirror..Your greed, lack of integrity and irresponsibility has ruined life’s...My son is hurt when I hide in the car to watch his soccer games. My mother is sad when she watches me isolate myself from the things and people I love because I have sores and scars covering my face now...Knowing It hurts them is the worst feeling I've ever experienced....One you are obviously incapable of comprehending since you continue these practices today...It’s pure evil and you should be the ones crying or sitting in prisons.

Today is my birthday..The second one I will spend sad and crying with sores and scars on my face, I feel like a caged animal, my phone is turned off and I wonder if I will ever look normal again…Enjoy a birthday dinner, Cheer on the field at my sons soccer game, Go to lunch with my Mom, Attend parties, Go on vacations, Visit my neighbors or Go out with my friends and family ect ect…..

I hope you read this and I hope you think of us when you enjoy theses simple pleasures you have taken from me and my family…Maybe it will take you a few minutes longer to go to sleep tonight??? One can only wish..

To the Doctors performing this procedure Please Take it seriously learn everything before you put it on a patients face...Start with the person you intend to delegate it to...You took an oath when you became a doctor..We count on you to protect and guide us thru the mish mosh of info and the corrupt FDA..

Everyone has a right to make a living especially after so much education...But never at the expense of another....Do your homework...

Do not listen to sales reps.. Or base your decision on delegating this and profit margins..They take no oath, have no education requirements. If you do you don't deserve the title,trust or respect we give you..

You will quickly become a commodity to greedy executives with half your education Please honor your oath and put pressure on peers to disclose..

If I wanted to get a sales reps opinion I’d talk to a sales rep Not my doctor….

Updated on Apr 2, 2009:

I felt a strong need to update this based on the positive reviews I am seeing 24 hours after the procedure... I thought it was fine 24 hours after and was looking forward to the results..

It's impossible review a treatment 24 hours or even weeks after when the results are not visible for months... While helpful in describing what to expect during treatment they should in no way be taken as a positive result.......

If you read the negative reviews you will notice most are months or years after treatment and are not happy ..They say they look much older or it ruined their skin....At this point you can pretty much determine the final result..

I wanted to make sure people considering this treatment put the appropriate weight on the reviews they read...The length of time after treatment should be taken into consideration when making your decision...As results and complications do not present immediately"

These are Angela's pictures:

Angela, the day before her treatment:

Angela, before her treatment that was done later that day:

Angela, one year after her procedure:

Angela twenty months after procedure:

Angela two years after her procedure:

Angela was brave to post these pictures, it was not easy. She told her story to warn others and hopefully save them from the fate that befell her.

Angela passed away last October after spending nearly two years hidden away from the world because of the depression and her self-perceived disfigurement from the Fraxel treatment. God bless her goodness and bravery. May she one day have justice for what happened to her life.

To her mother, son and family, I hope you know she was an inspiration and a heroine for what she did to protect and save others.

Visit the IPL and Laser Damage Support board and read the stories of those damaged by government approved cosmetic devices: http://iplandlaserdamagesupport.prophpbb.com/

Make an on-line slide show at www.OneTrueMedia.com