Aidpage

NICO LESION GOING PUBLIC

Guidance for Industry and FDA Staff

Class ll Special Controls Guidance

Document: Dental Amalgam Alloy

Document issued on: July 28, 2009

The draft of this document was issued on February 20, 2002

Bill Nelson U. S. Senator of West Palm Beach Florida emailed the FDA on my behalf concerning the bone disease NICO LESION/NEURALGIA INDUCING CAVITATIONAL OSTEONECROSIS. I received a letter or document from the FDA November 2009.

At this time I can give you the website regarding this document and to contact Michael E. Adjodha at 301-796-6276 or via email at michael.adjodha@fda.hhs.gov.

To request a fax 301-847-8149 TO receive a hard copy.

Alternatively, electronic comments may be submitted to http://www.regulations.gov.

ADDITIONAL COPIES ARE AVAILABLE FROM THE INTERNET AT:

http://www.fda.govMedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073311.htm.

http://www.fda.gov.MedicalDevices/DeviceRegulationguidance/Guidance/GuidanceDocuments/ucm084365.htm

http://www.fda.gov.MedicalDevices/regulationsGuidance/HowtomarketYourDivice/premarketSubmissions/PremarkwetNotifications510k/default.htm

http://www.fda.gov/MedicalDevices/DeviceRegulationdGuidance/GuidanceDocuments/080187.htm

http://www.fda.gov/MedicalDevices/DevicesRegulationsGuidance/Overview/MedicalDeviceProvisionsoffFDAModernizationAct/ucm136685.htm

This website is the 10 page document the FDA mailed me concerning DENTAL AMALGAMS AND THE RISKS TO YOUR HEALTH. I will scan the entire document and post it soon.

God Bless.

belle

Reply to belle:---My Lord! how awful for you, but are women warned about this when they choose to take birth control.? I think of all the years I took birth control and never heard one word about Nico Lesion and just last year I had to go on steroids for a very bad case of pneumonia and upper respitory problems. Why wasn't I told about what could happen while taking this medication? I can't thankyou enough for explaining this to me and I hope you can find help here on aidpage. If  you need anymore help finding resources let me know and I can direct you to someone that can help you. sincerely sheshe030

First of all, who diagnosed Nico Lesion? This bone disease IS NOT reconised by the U. S. FDA. making it almost impossible to get diagnosed correctly. The dentists and oral surgeons have no clue how to read beyond the root in a panoramic due to the fact their not educated to do so. Read my website under nico lesion and lyme disease and if you have any further questions I'll try and assist you. I'm not a doctor, just an educated patient who is trying to get this bone disease reconised by the U. S. FDA.

Belle

4 justice,

Nico Lesion is a bone disease in the mandible and maxilla face bones. Their are many different reasons which cause this painful disease. Steroids and birth control play a large role in Nico causing osteonecrosis(dead bone) in you manible, maxilla and hip bone areas. This disease induces through your bone marrow which can spread into your entire body. Root canals can infect the mandible and maxilla bones causing osteomylitis(infected bone). Nico can affect every part of your body. The diseases nico causes just to name a few are osteoporosis, heart disease, TMD.

Please read my website under nico lesion. The sight will be in capital letters headed lyme disease and nico lesion. It's quite extensive and will explain any further questions you may have. I also sign my name as belle from the aid page.

Belle

Reply to 4justice:---I have seen that name Nico Lesion on another aidpage post quite awhile ago. What is a Nico Lesion and how does it affect your hralth and work? sheshe030

I  have just been diagnosed with this and have had to even defend my job. It is new to me so any advice or help would be appreciated.

I emailed President Obama today of my concerns on the bone disease Neuralgia Inducing Cavitational Osteonecrosis I'm also working with attorneys who have been contacting health channels to finally make this horiffic bone disease known to the public. I will keep you imformed on my progress, I'm determined to get this reconised by the U. S. FDA.

I'm in need of additional attorneys compentant in the media area on the bone disease Nico Lesion.  Please email me:  ljz0917@yahoo.com.

I met with Senator Bill Nelson in West Palm Beach, Florida on July 23, 09. He had just left for Washington D. C. but arranged for me to meet with Michelle Oyola McGovern, his Regional Director or right hand person. I explained Neuralgia Inducing Cavitational Osteonercrosis or Nico Lesion to her quite extensively. She has been informed this dehilibating disease IS NOT reconized by the U. S. FDA and people internationally are suffering horiffics deaths and many sucides happen from the pain from Nico Lesion. I told her Nico Lesion need to made public so people can get help. I explained the surgery process throughly and told her IT CAN BE REMOVED through cutting the diseased affected area'a out with a spoon shaped scaple. She was also informed that Nico Lesion IS NOT being taught in dental schools internationally and just a simple panoramic with a trained eye can detect osteonecrosis, osteomylitis and more. I told her if I could read the pano certainly professors in dental school should be able to find the Nico and again, this isn't rocket science. I informed her I wasn't a doctor, just an educated patient who has been researching Nico since 1998. I've lost 15 years of my life to this bone disease and told her I continue to suffer with horiffying pain and CAN NOT get help due to the fact of Nico not being reconised. She was also informed I've traveled to Europe, Canada and 12 different states in the U. S. trying to get diagnosed from the knife stabbing bone pain. She knew other diseases of the body were related to your teeth and bone and actually knew it spread through the bone marrow. Again, I informed her I wasn't a doctor but asked her to please google NICO LESION and read all websites. I disclosed no names but did inform her DDS were being closed down by the FDA just for trying to help people like myself and people flying in internationally. She said she'd be on the phone with Senator Bill Nelson that day and would pass on all information I gave to her. At this point, just pray and ask the Lord if he could help people out with NICO LESION going public. I also shared the cavitat scan with her and told her it was aproved for diagnosing bone deteriation of the mandible and maxilla bones. I showed her mine which of course was 100% correct in the cavitat scanning.

I don't have a scanner at thr present time so therefore I will type and post the letter from UNITED STATES SENATE, WASHINGTON, DC 20510-0905. AUGUST 14, 2009. From SENATOR BILL NELSON, WEST PALM BEACH, FL.

Dear Ms Zekan:

Thank you for contacting my office(in person) regarding your desire for the U. S Food and Drug Administration to recognise Maxillofacial Osteonecrosis (NICO) as a disease. I appreciate being made aware of your concerns and will be pleased to look into this matter.

Currently, I am in touch with the FDA on your behalf. As soon as I have a responce, I will share the results with you.

Again, thank you for contacting my office. I want you to know that as your U.S. Senator from Florida, I welcome the opportunity to serve you. If I can assist you with any other matter, please do not hesitate to let me know.

Sincerely,

Bill Nelson(signature)

BN/mer

God Bless,

belle

I'd like to imform doctors I have lined up an interview on a news station in Miami, Florida. The health news station has asked me to find a doctor who is educated in Nico Lesion. I will keep you imformed, the doctor will be flying into West Palm Beach very soon.

God Bless,

belle

I actually heard back from the FDA on Nico Lesion. They are trying to tell me the devise I used wasn't a bone disease. I'll post it soon, it's 40 pages and they actually gave me 4 phone numbers to call.

Channel 10 news in Miami is still waiting to interview me on Nico Lesion. They want a doctor to be interviewed with me which will never happen. Anyone have any idea's?. I was shooting for a M. D. or D. O.

God Bless,

belle

December 1, 2009

I'm finally posting the correspondence I received from the U. S. Department of Health Human Services on the bone disease Nico Lesion. The information is insulting and basically being based on amalgams.

United States Senate

WASHINGTON, D.C. 2051`0905

BILL NELSON

FLORIDA

Dear Ms Zekan:

In response to my inquiry on your behalf, I am enclosing a copy of the coorespondence I received from the U. S. Department of Health and Human Services. I appreciate you giving me the opportunity to look into this issue.

If I can assist you with any other matter, please do not hesitate to let me know.

Sincerely,,

Bill Nelson

signature

BN/mer

enclosure

Bill Nelson went to bat for Nico Lesion but got nowhere.

Dear Ms. Zekan:

This is in response to your letter address to Senator Nelson regarding dental amalgams and your request for the Food and Drug adminstration (FDA) to recognize Neuralgia Inducing Cavitational Osteonecrosis (NICO) as a disease. Senator Nelson has forwarded you a letter to FDA for response.

First, I would like to say I am sorry to hear about the health issues you have endured. FDA takes the reporting of adverse events seriously. The agency is responsible for assuring the safety and efficacy of these devices. I have forwarded your letter to FDA'S Center for Devices and Radiological Health for their review. So that the FDA may have a better understanding of your adverse events, we encourage you to use one of the following methods:

#Phone 1-800- FDA-1088

#FAX to 1-800-FDA-0178;

#Mail to Medwatch, Food and Drug Adminstration, 5600 Fishers Lane, Rockville, MD 20857; or

#online at http://www.fda.gov/medwatch/report.htm

I have also enclosed a copy of FDA's final rule that issued July, 2009, which classified dental amalgam into Class 2, Special Controls. The agency believes that the special controls provide a resonable assurance of the safety and effectiveness of these devices and that when subject to general and special control's, valid scientific evidence demonstrates the absence of unreasonable risk of illness or injury associated with intented use of amalgam.

In regards to your request for the agency to recognise NICO as a diseade, FDA does not determine what constitutes as a disease.

Thank you for taking the time for your concerns.

Sincerely,

Wanda Russ

signature

Wanda Russ

Policy Analyst

FDA Executive Secretariat

Department of Health & Human Services

Food and Drug Adminstration

Silver Spring, MD 20993

November, 23, 2009

Matthew Rankin

Staff Assistant

United States Senator Bill Nelson

Landmark Two

225 East Robinson Street, Suite 410

Orlando, FL 32801

Dear Mr. Rankin:

This is response to the October 29 letter from Senator Nelson addressed to Secretary Sebelius on behalf of his constituent Laurie Zekan, regarding dental amalgams and her request to reconize dental amalgams and her request to reconize Neuralgia Inducing Cavitational Osteonecrosis as a disease. The secretary has forwarded Senator Nelson's letter to the Food and Drug Administration (FDA) for response to Ms. Zekan.

Sincerely,

Wamda Russ

signature

Wanda Russ Policy Analyst

FDA Executive Secretariat

I will post the 11 page Guidance for Industry and FDA Staff.

Class 2 Special Controls Guidance

Document: Dental Amalgam,

Mercury, and amalgam Alloy

NICO LESION IS A TRUE BONE DISEASE WHICH SPREADS THROUGH YOUR BONE MARROW IN YOUR MANDIBLE AND MAXILLA JUST LIKE BONE CANCER. THE BONE DIES AND BECOMES NECROTIC(DEAD). OSTEOMYLITIS(BONE INFECTION) ALSO SPREADS THROUGH THE BONE MARROW AND CAN TRAVEL THROUGH YOUR ENTIRE BODY.THE WEBSITES, BIOPSEY REPORTS, MUTATED V-LEIDEN GENE, ROOT CANALS, AMALGAMS, INFECTED WISDOM TEETH, AND THE LIST GOES ON WERE ALL INCLUDED IN MY RESEARCH TO THE FDA. THEY CHOOSE TO WIRE IN ON AMALGAMS WHICH EVIDENTLY ON THEIR BEHALF HAVE RECONIZED THEM AS A HAZZARD.

God Bless,

belle