LASIK Patient Advocacy Network
The purpose of this cause is raise awareness of problems and risks of LASIK surgery, and to serve as an advocate on behalf of LASIK patients. Learn More
Our Petition Makes FDAWeb Review. How can the media ignore this?
FDA Public Health Advisory Sought on LASIK Hazards 11/06/2009 “The FDA’s mission is to serve and protect the public, not to serve industry,” says a 126-signatory letter to CDRH acting director Jeffrey M. Shuren, seeking a public health advisory on “the high incidence of adverse events and long-term consequences asso… Read More
Recent Cause Activity
Dear Hurt LASIK Patients:
Thank you for taking the time to reach out to us about your poor LASIK outcome. I’m sorry to hear that you suffer permanent Adverse Events/Complications for elective LASIK surgery. You, like tens of thousands of us, suffer daily visual debilitating challenges. All because we were told that LASIK was practically “risk free” and that we were “the perfect patient candidate” for this procedure. In reality, we like millions of others, were not the perfect patient candidate, but rather used and abused all for the sake of $5,000.00 for a ten minute procedure that is marketed to the masses as “risk free, pain free, miraculous, throw your glasses and contacts away forever.”
Well, what’s done is done correct? There’s no going back now correct? What you decide to do from here, will shape the course for the rest of your life, and your family’s life. You can either do nothing, allowing your doctor and commissioned staff, to get away with having permanently ruined your vision, and you can fall into a deep state of depression affecting every bit of your daily life and your family’s, or you can start today trying to better yourself and improve your post LASIK vision, by trying different specially made contact lens and also start today by telling “your story of what transpired to you” to everyone you know so that you can help protect others from this “marketed safe and elective surgery.”
A couple of suggestions for you, if you are open and ready, to help yourself and help protect the public:
#1. Had A BAD LASIK Outcome? Complain to the FDA! Let them know you are not happy by filing a Medwatch Report for each of your eyes that are permanently ruined because your LASIK doctor and their staff are not going to file this for you and don’t want the FDA to know about this. That would end the millions they are making off of all of us! Fill Out FDA Complaint Form By Clicking Below: Fill Out Form, Write Down Case#: The FDA says there have only been 142 complaints in 10 years, when the FDA doesn't even count the complaints
on their LASIK section. You have to go to a completely different website in order to have your complaint count!
https://www.accessdata.fda.gov/s... .
#2. Did You Think About Suing Your LASIK Doctor, Laser Manufacturer, and Possibly The Staff? There is only one attorney that I am aware of that has had good results at winning the LASIK medical malpractice or criminal intent lawsuits. Here is his information below:
Todd J. Krouner
Law Office of Todd J. Krouner
93 North Greeley Avenue, Suite 100
Chappaqua, New York 10514
Tel: 914-238-5800
Fax: 914-238-8544
Email: tkrouner@krounerlaw.com
Website: www.KrounerLaw.com
#3. Is Your LASIK Doctor Compliant To The Following FDA Laws In A: Reporting All Hurt LASIK Outcomes (Filing a Medwatch Complaint) and B: Stating All Known Risks In Every LASIK Advertisement? Email CC: timothy.ulatowski@fda.hhs.gov (Director of Advertising/Compliance at FDA).
May 22nd, 2009 FDA Letter “Stating All Risks Must Be Mentioned In Every LASIK Advertisement:”
http://www.fda.gov/MedicalDevice...
Mandatory LASIK Medwatch Filing Required By Law To Be Performed By LASIK Centers:
http://www.fda.gov/MedicalDevice...
#4. Who Can Give You An Honest Assessment Of Your Post LASIK Vision, And Who Can Help You Get Back On Track? Over the past 11 years, Dr. Boshnick is the only one that I would go to or recommend other hurt patients to first visit. Half of his life’s work is spent trying to help hurt LASIK patients like us. He truly cares.
Dr. Ed Boshnick
Westchester Shopping Center
8479 Coral Way
Miami, FL 33155
Tel: (305) 264-4400
Email: ed@boshnick.com
Website: www.eyefreedom.com
Good luck to you! Know that this is going to be a process. You will have good days and you will have bad days. I would suggest that you keep a journal and write down what the weather, your diet, your drinking habits are like on both the “good and bad days.” This way, you can see what effects your vision. Like most of us, the hardest part of “your new life,” is that you have variable vision and you see through it, distorted as it may be daily, but yet others around you can not see it and will tell you that you look just fine. In otherwords, “they can not see what you see.” Call me anytime if I can be of help. I’ll be praying for you to get better.
Kind Regards,
Dean Andrew Kantis
Founder
www.LifeAfterLasik.com
754.234.9993
As casualties of LASIK, many of us have been left with a loss of quality of life that sometimes seem insurmountable. But there are things that we can do to get back in touch with our former selves. Things that will allow our minds that are filled with frustration, anger, resentment, sadness, depression, despair, etc. to feel peace again. One of the things I have talked about in the past is Dr. Edward Boshnick, and the amazing work he is doing with LASIK patients with special contact lenses. Now I want to tell you about another tool. This is a retreat, a place of healthy living, pampering, and healing. It is not all foo foo, and it does not cost an arm and a leg, after all, we have already given up out eyes.
I
The name of the spa is called The New Age Health Spa. The name is sort of a misnomer, because when they opened the spa like 17 years ago, that whole New Age movement was started, and it evolved into whatever it is today. But when I think New Age, I think all crystals, and Karma, and words like “dude” come to mind. So let’s just say that my impression is off base. The place has no philosophy or religion to force upon you. You can do as much or as little of their offerings as you like. The only thing you can’t do is disturb the tranquility or bring alcohol onto the premises.
The New Age Health Spa is located on Route 55 in the beautiful Catskill Forest Preserve in upstate New York, home to our (New Yorker’s) drinking water. To me, this place was magical! While I was there, there was a period of 48 hours in which I experienced total peace and contentment, and that is miraculous Indeed.! If one were to take all of the moments of peace and contentment that I have experienced over the course of my entire adult life, and concatenated them together, it would not add up to 48 hours - That’s the profound effect this place had on me.
What was it that had such a profound effect? It was a combination of things: tuning out the usual hustle and bustle of the outside environment, being in a sparse, but clean and well maintained setting that was surrounded by God’s beauty - natural forests and lakes, and the animals that inhabit them. It was the wonderful amenities and services that the spa offers (many kinds of massage, aromatherapy, hypnosis, dance, a gym, indoor and outdoor pools, sauna, steam room, hot tub, psychic body work, tarot card reading, facials, scrubs, wraps, nature walks, relaxation techniques like the Alexander Method, and more). It was also the delicious food that was prepared from all natural and organic ingredients to be healthy, the general good natured attitude of all the guest’s who came from every walk of life, many professionals from the city, and most importantly, it was the extremely knowledgeable, good natured, and exceptional staff. From the housekeeper who makes your bed, to the chef, to the dining room staff, to the laundry people, to Russell who grew every herb and salad green with such care and devotion, to each instructor, and massage therapist, to the guest lecturers, is was easy to see that they really loved where they worked, loved what they were doing, and had a sincere desire to nurture and help others. This is uncommon!
There are so many people who work there that are special that I would love to tell you about, but everyone there is special, so I don’t want to start to single people out and maybe miss someone. Suffice it to say, that I was major impressed with these people, and they really helped me physically, and mentally. Your spirit can not help but be touched by the environment and the people there. Like I said at the beginning, it’s just magical.
It’s also very affordable, considering all that you are getting. If you are stressed out, depressed, anxious, or just feel like pampering yourself in a more rustic and natural environment, go to www.newagehealthspa.com and check it out. If you decide to give it a shot, tell them that I sent you !
Way to go Scott Tolchin for being so passionate about these points. I seek truth, not fabrication. I encourage everybody to seek truth, no matter how hard it is and no matter where it takes you. Way to go Scott!!
,
D
Many of us LASIK patients with adverse effects suffer from anxiety, depression, or PTSD. I recently learned an amazing relaxation technique that may be of some benefit to you. It is called the Alexander Technique. It uses your body to relax your body and your mind. It only takes about 3 minutes to work, once you get it. It is called Alexander Technique because it was developed by F. Matthias Alexander, who, in the 1890s, developed its principles as a personal tool to alleviate his breathing problems and hoarseness and hence enable him to pursue a career as a Shakespearean actor.
A friend of mine texted me in a bit of a panic in the middle of a department store, and I told him to find a corner, and I tried to text him through this technique. He texted me back that within 3 minutes his symptoms disappeared, and he completely blocked out all of the chaos going on around him. Here is what I texted him. I hope it works for you to:
Stand in a quiet place where you won't be disturbed. You can do this with your eyes open or closed. It doesn't matter.
Place your feet a little less than shoulder with apart, planting yourself to the ground. Face forward, and drop your jaw gently open and relaxed, You do not drop your jaw by opening you mouth with your head. You drop it by just letting it hang down. You may feel a little self conscious - let that thought go. It may feel like you might drool, but you won't. I checked myself in the mirror and I did not look weird. I thought that I was going to look like I had no intelligence, or like I was stoned, but I didn't. I just looked relaxed.
Now make sure that your shoulders are relaxed and that your head is just sitting on top of your spine. Imagine that there is a horizontal line that starts just under temple on the left side of your head, and runs straight through your head to the space just below your right temple. In the middle of this line is where your head attaches to your spine. Your head just sits on top of your spine there like a bobble head.
So now you are facing forward with your jaw dropped open and relaxed. You face should feel relaxed. Your head should feel like its just balancing gently on the top of your spine from the middle of that imaginary horizontal line's center.
Now make sure that your shoulders are relaxed with your arms just hanginging down, like a skeleton.
Now if you can, touch the back roof of your mouth with your toung. That is your soft palate. That is where the sound that your are gooing to make will be coming from. Relax your tongue and jaw again, and concentrate on that soft palate. You're just standing there facing forward like a Raggedy Ann doll.
Now, whisper the word "Ahhhhhhhh". At first you will probably say "Hhhhhhh". That is not it. Hhhhhh comes from the front part of the thought. Ahhhhhhhhh comes from that soft palate in the top back part of your mouth.
Breath in through your nose and whisper a long Ahhhhhhhh. Make sure it starts with the letter "A" and comes from that soft palate.
Repeat this gentle breathing in through your nose into your abdomen, and out by whispering the word Ahhhhhhhh from your soft palate. You should start to feel relaxed.
Do this several times gently and feel yourself relax. Your feet are solidly planted. You are gently standing up, you head is face forward, balanced on your spine. Your mouth is dropped open, just hanging there. And your arms and hands are just hanging down from your shoulders at your sides. Your fingers may tingle a bit, that's fine. Just breath in gently through your nose into your diaphragm, and when you breath out, whisper the word Ahhhhhhhhh from the top back soft palate of your mouth.
Once you feel relaxed, start to walk slowly around. Notice how you are walking. You may feel slow, relaxed, lazy. That's all good. You may think that you look like a zombie, but you don't. You just look like you're floating along and whispering the word Ahhhhhhh.
You must have an "A" sound starting. It's a whisper, not a chant. It sounds like "Hhhhh" but it has to be "Ahhhhh". If you get it, you'll know it because you will instantly calm down and all tension and anxiety will disappear.
Practice this for 3 minutes every so often, and when you get stressed and need it, it will be there for you to use anywhere, anytime. It's extremely effective and quicker than Xanex!
Restorative Alexander Technique - You can do this once or twice a day as your own little spa treatment:
Lie on your back with your feet flat on the floor and a little wider than shoulder with apart. You knees are facing the ceiling and are rounded. Keep you hands to your sides, head and spine straight but relaxed.
Close your eyes and do the same technique I described above. If you want, you can gently rock your head slowly from side to side, breathing in on one side and whispering Ahhhhhh as you move to the other side. Then just rest your head straight and do it.
When you're ready to get up just drop both knees to your right side and turn to the fetal position. Rest there a few seconds or as long as you want. And when you're ready to get up just push up slowly with your hands until you are in a seated position. Then stand up slowly, so you don't get dizzy. Now walk around slowly and do a few more whispered Ahhhhhhs, and you're good to go.
Peace
Fixing FDA: Term Limits for Managers Not Likely
11/02/2009
Just as term limits for elected lawmakers haven’t gained much traction as a remedy for poor governance, they’re unlikely to be tried as a remedy for lackluster management at FDA, either. The idea came up among reader comments on last week’s report about an address to the Alliance for a Stronger FDA by principal deputy commissioner Joshua Sharfstein entitled “FDA’s Credibility Matters ‘A Lot’.” Readers within FDA quickly latched onto Sharfstein’s vows to improve credibility, many pointing a critical finger at FDA managers — including even Sharfstein himself, in one case, for not answering those whose suggestions he had solicited within FDA
“My idea was submitted,” one commenter scolded, “and as I figured, nothing ever came of it. Never even received an answer. Total joke. … I, to this day, still believe that I could do a much better job running things than most. That is because I would surround myself with good people, and not the 'bobbleheads' that continue to be moved up into higher and higher positions. Remember, it’s not what you know, but definitely WHO YOU KNOW!”
This observation seemed to strike a chord, because others chimed in, agreeing. “So-so managers do exist everywhere,” one commented, adding: “All managers probably should be rated by each of their subordinates. But the real problem is the ‘bad managers’ as government positions are permanent. So, probably all managers should have a term, just like our commissioners. This way, at least people can have some hope.” This commenter said a good degree from a good school is not enough — “FDA regulation requires knowledge in both science and law. Experience is good for regulation and leading reviewers. But, leadership requires not just experience and knowledge but personality and ability to lead.”
Another commenter hoped that Sharfstein would “go down to the trench and talk to reviewers to have some true understanding” as former CDER director Steven Galson and former acting commissioner Frank Torti had done. Agreeing that it was disappointing that reviewers’ ideas sent to Sharfstein “never got discussed or explored further,” this critic said that that “Listening to second- or third-hand report is never going to work well, especially considering a place that is so enormous and with such a long history of communication problems.”
Yet another commenter agreed that FDA needs to “improve internally. The majority of our division works through a lack of respect to our division director; his credibility, simply said, is shattered. Making things worse is the lack of interest shown by the office director to deal with the problem.
Asked to comment on the term limits idea, Sharfstein told us that in his experience, “good managers are critical to an organization. I would be wary of any policy that could move good managers arbitrarily.”
Courtesy FDAWeb Review - http://www.fdaweb.com
Some idiot reporter from the Washington Post really botched a LASIK story, but if you look at these statistics, they paint a more realistic picture: http://www.washingtonpost.com/wp...
Republicans Draft Debarment Bill
10/27/2009
Republicans on the House Energy and Commerce Committee have drafted legislation to strengthen FDA’s ability to rapidly debar researchers who have been convicted of crimes. The legislation comes in the wake of a Government Accountability Office probe that found it often took FDA four years to ban researchers whose studies had been tainted by illegal actions and professional misconduct. The report also said that FDA lacks legal authority to debar investigators who broke the law while researching medical devices.
The bill is sponsored by Reps. Joe Barton (R-TX), John Shimkus (R-IL), Mary Bono Mack (R-CA), Lee Terry (R-NE), John Sullivan (R-OK), Michael Burgess (R-TX), and Marsha Blackburn (R-TN). “FDA has failed to make its debarment authority work, and now the GAO report offers the latest details of a record of the agency’s weaknesses and failures,” Barton said. “I think it is especially inexcusable that the agency can’t seem to quickly and consistently debar even convicted felons.”
The bill would:
1. give FDA authority to debar any company or individual who is convicted of crimes relating to any drug or device;
2. give FDA authority to debar a medical device company;
3. give FDA authority to debar companies for any misconduct relating to the drug or device, not just over misconduct that takes place during a drug or device’s development or approval;
4. provide greater accountability by requiring FDA to bring debarment actions within one year of the date of conviction; and
5. require FDA to report to Congress on the number of debarment proceedings initiated and imposed each year.
Source: FDAWeb Review - http://www.fdaweb.com
FDA Can Improve Device Adverse Event Reporting: OIG
10/27/2009
The HHS Inspector General (IG) says that CDRH doesn’t use medical device adverse event reports systematically to detect and address safety concerns about medical devices. The critique is in a new report on adverse event reporting for medical devices.
The IG recommends that FDA develop a protocol for reviewing adverse event reports that specifically addresses several needs and that FDA seek legislative authority to eliminate the requirement for user facilities to submit annual reports. FDA agreed with both recommendations.
The IG’s analysis was intended to determine the extent of adverse event reporting from 2003 to 2007 by manufacturers and facilities that use medical devices, the extent to which manufacturers and facilities that use medical devices comply with adverse event reporting requirements, and how FDA uses medical device adverse event data to identify and address safety concerns.
The study found that overall FDA received twice as many adverse event reports for medical devices in 2007 than in 2003, although some types of reports decreased. It says that 30-day reports of death, serious injury, and malfunctions accounted for almost all manufacturer reports and drove the overall increase in reports. Five-day reports made up less than one percent of manufacturer reports and dropped from 432 to 54 reports per year over the five-year period. Although manufacturers submitted most adverse event reports on time, many five-day manufacturer and user facility reports were late.
The IG says that CDRH analysts documented little of their reviews, making it difficult to trace the response to an individual event. While outcomes of adverse events can result in a variety of postmarket surveillance activities, CDRH cannot link the activities to particular adverse events. The Center also reportedly lacks an established system to document when adverse event reports result in onsite inspections. And CDRH’s Office of Compliance was found to not document which reports resulted in inspections when analysts refer the reports and to not document onsite inspections in the MAUDE adverse event database.
“CDRH does not consistently read adverse event reports for the first time in a timely manner,” the report says. “Analysts read fewer than one-third of adverse event reports for the first time within 30 days and less than half within 60 days in every year from 2003 to 2007. CDRH’s procedures require that high priority adverse event reports be in MAUDE and ready for analysts to review within 96 hours of receipt; however, we were unable to verify CDRH’s compliance with these procedures through its documents.”
In addition, the IG found that CDRH rarely acts when manufacturers and facilities submit reports late. Analysts reported that they generally forward concerns about timeliness only when they notice pervasive problems, and they usually handle concerns informally by calling the manufacturer.
The inability to obtain complete and usable information in adverse event reports was cited by the IG as a hindrance to analysts’ review of reports. The analysts also said that MAUDE is an impediment because they cannot easily conduct trend analysis and MAUDE doesn’t connect with other CDRH databases.
The study found that CDRH makes only limited use of annual reports. Of the 526 facilities that the IG says should have submitted annual reports for 2006, CDRH could provide only 220 of the reports. The IG could not determine whether facilities had not submitted reports or CDRH was unable to supply copies.
The IG called on FDA to develop a protocol for reviewing adverse event reports that would: (1) document follow-up on adverse events; (2) ensure and document that CDRH is meeting its guidelines for reviewing all five-day and Code Blue (pediatric death, multiple deaths, exsanguinations, explosions, fires, burns, electrocutions, and anaphylaxis) adverse event reports; (3) follow-up with manufacturers that routinely submit reports late or with incomplete information; and (4) enhance outreach strategies to reduce underreporting by user facilities. FDA should also seek legislative approval to eliminate the requirement for annual reports from user facilities, the IG says, to decrease the regulatory burden on facilities and on CDRH. Other than a count of total adverse event reports, all the information in the annual reports is redundant to the originally submitted reports.
FDA is said to have agreed with both recommendations. It indicated that it will develop a clear review protocol addressing the needs identified in the report. The agency said that its new adverse event database will allow for more extensive documentation of follow-up on adverse events and permit FDA to more readily identify late and incomplete reports. The agency also reported that CDRH has developed a tracking system that facilitates referrals to the Office of Compliance and follows up on them. Finally, FDA said it will take steps to stimulate user facility reporting.
Source FDAWeb Review - http://www.fdaweb.com
Be careful of the following LASIK doctors at these facilities, thanks to us, they all just got FDA WARNING LETTERS: http://www.fda.gov/ICECI/Enforce...
The 17 warning letters to LASIK clinics are currently listed on the FDA page of recent warning letters:
http://www.fda.gov/ICECI/Enforce...
FYI... this is a temporary location for links to these letters.
Group Asks for Recall of ‘All-laser LASIK’ Devices
10/15/2009
LASIK Surgery Watch (LSW) says FDA should recall laser keratome devices used for LASIK flap recreation due to its negligence in clearing them without rigorous clinical trials. In a 10/10 letter to CDRH Office of Device Evaluation (ODE) director Donna-Bea Tillman, LSW cites a 10/14/08 letter from CDRH scientists and physicians to Rep. John Dingell (D-MI) on abuse of the 510(k) program by clearing devices that were never evaluated for safety and effectiveness.
LSW also tells Tillman it was “pleased to learn of your personal effort as director of the Office of Device Evaluation at FDA to address ‘integrity’ problems of the beleaguered 510(k) program.”
It asks that ODE review the appropriateness of the 510(k) approval process for femtosecond ophthalmic laser keratomes, which have been cleared as substantially equivalent to predicate IntraLase lasers that were approved as substantially equivalent to a metal blade keratome and an obsolete dissimilar ophthalmic laser.
“While the intended use of both blade and laser keratomes is to create a flap in the cornea, technological characteristics of these two devices are not similar as required under 510(k) guidelines,” the letter says.
LSW says that an obvious omission in the marketing of all-laser LASIK is the new technology’s “spectrum of new complications” that were never encountered with blade keratomes. The group says that peer-reviewed literature of IntraLase LASIK reveals numerous reports of complications unique to laser keratomes, as well as flap complications similar to those associated with metal blade keratomes. And it says that FDA’s MedWatch shows complications associated with laser keratomes, including some that are unique to the device. But LSW claims that the true incidence of IntraLase complications isn’t known due to the widespread failure of LASIK surgeons to file adverse event reports and the ignorance of affected consumers that they can file their own reports.
A group of LASIK patient advocacy organizations are co-sponsoring a letter to the acting director of the FDA Center for Devices and Radiological Health. The letter requests that the FDA issue a public health advisory regarding the risks and long-term consequences of LASIK.
Please show your support of this effort by going to www.lasikadvisory.com/ and adding your signature to the letter.
Thank you!
FDA is asking consumers to please file a Medwatch complaint if you suffer from any of the following LASIK symptoms in (1) or (BOTH) eyes: itching eyes, dry eyes, eye pain, double vision, halos at night, difficulty driving at night, unstable vision during the day, regression of quality of vision, depression, suicidal ideation, loss of work, headaches, or anything else that you feel happened "after" you had elective LASIK surgery: https://www.accessdata.fda.gov/s...
FDA is asking consumers to please turn in any LASIK doctor who is not listing "ALL RISKS" in any print, newspaper, magazine, tv, radio or online advertisement for LASIK as all US LASIK facilities have all received warning letters from the FDA about this:
October 22nd, 2009: FDA is asking consumers to report any LASIK doctor advertising without listing "All KNOWN RISKS:"
http://www.fda.gov/ForConsumers/...
October 20th, 2009: LifeAfterLasik Asks Dr. Waring III (Editor of Journal of Refractive Surgery) To Include Hurt LASIK Advocacy Groups Efforts In "Post LASIK Quality of Life Study" So That Honest Results Can Be Concluded:
http://lifeafterlasik.com/LASIK%...
Dr. Rupard states "LASIK causes a decline in lacrimal gland function" which are "known long term problems of every LASIK surgery:"
http://lasiksurgerywatch.org/voi...
October 16th, 2009: LASIK Surgery Watch Sends Letter To FDA's Device Evaluation Dr. Tillman Asking To "Pull LASIK Devices" Until Real Clinical Studies Can Be Performed To Guarantee Patient Efficacy and Patient Safety:
http://lifeafterlasik.com/LASIK%...
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Just goes to show you, when it comes to LASIK physicians, they will do anything for money. Check this out: http://www.edmontonsun.com/news/...
or
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