The following letter was sent to members of the U.S. House of Representatives Committee on Energy and Commerce and Subcommittee on Oversight and Investigations and others members of Congress.
May 8, 2009
The Honorable Henry Waxman
Committee on Energy and Commerce
2125 Rayburn House Office Building
Washington, DC 20515-6115
Dear Chairman Waxman:
My name is Scott Tolchin and I am the founder of the LASIK Surgery Watch Cause (LSWC) on Facebook. LSWC is a community of individuals that include patients damaged by LASIK surgery. The mission of the LASIK Surgery Watch Cause is to advocate on behalf of patients who have suffered adverse effects of LASIK surgery so that they can be counted, heard, and understood.
I am seeking an immediate moratorium on the use of excimer lasers for LASIK surgery as there has never been a clinical trial to support the safety guideline of less than 1.0% occurrence of adverse events required by the Food and Drug Administration (FDA) for approval.
Approximately 20% of patients in FDA clinical trials for LASIK reported complications (glare, halos, night driving problems, and dry eyes) at six months after surgery which were worse than before surgery, much worse than before surgery, moderately severe or severe. These complications were deceptively reported in clinical trials as “symptoms” rather than “adverse events” in order to satisfy safety guidelines. In 2008, the FDA reclassified these complications as reportable adverse events; however the agency allowed these devices to remain on the market for use in LASIK surgery.
Additional bases for a moratorium on LASIK devices include:
- The FDA has been negligent in its oversight of LASIK ambulatory surgical facilities (ASF). Part 803 of 21 CFR establishes reporting requirements for users of medical devices. Specifically, all LASIK device user facilities must submit FDA MedWatch reports of individual adverse events; establish and maintain medical device reporting (MDR) event files; develop, maintain, and implement written MDR procedures; and submit annual reports to the FDA. It is clear that users of LASIK devices have systemically failed to comply with MDR reporting requirements, which contributed to the FDA’s failure to monitor safety of LASIK devices post-market. This situation must be immediately rectified in order for the FDA to fulfill its post-market surveillance obligation.
- In May, 2008 a citizen petition was filed with the FDA to ban LASIK due to substantial deception in the labeling and an unreasonable and substantial risk of injury. The CDRH has failed to respond to the petitioner within the 180 deadline established by 21CFR Sec. 10.30.The petition references data from FDA LASIK clinical trials, which establish the failure of LASIK lasers to meet the FDA’s safety requirements for approval. It appears that the FDA was derelict in its approval of LASIK devices, putting the interests of the ophthalmic industry ahead of its duty to protect the public health. The petition can be viewed at www.Regulations.gov, Docket ID FDA-2008-P-0319.
- Transcripts of Ophthalmic Devices Advisory Panel meetings indicate that the FDA knew, or should have known, of serious problems with the LASIK procedure.Warning letters dating back to at least 1999 were issued by the FDA to LASIK clinical trial sponsors indicating deviations and deficiencies in the sponsors’ responsibilities to ensure that the studies were conducted in accordance with applicable FDA regulations.
- FDA clinical trial study design for LASIK lacked sufficient duration of follow-up to detect late onset complications, such as corneal ectasia, a serious sight-threatening complication of LASIK that may occur years after the procedure.The small patient population and short-term follow-up did not allow for thorough examination of adverse events and long-term consequences of LASIK.
- According to the American Academy of Ophthalmology (AAO), dry eye is the most frequent complication of LASIK; however, assessment for dry eye in LASIK clinical trials were purely subjective – there was no objective dry eye testing.Corneal nerve damage resulting from LASIK surgery leads to loss of corneal sensation, which invalidates subjective patient questionnaires in detection of post-LASIK dry eyes. Microscopic examination of post-LASIK corneas reveal reduced nerve density three years after surgery. The true rate of clinical dry eye after LASIK is likely much greater than reported in clinical trials.
- The importance of pupil size in LASIK screening and surgical planning has been systemically ignored by LASIK clinical trial sponsors and investigators and dismissed by the FDA.Objective tests demonstrate that visual aberrations increase with increasing pupil size after LASIK. Failure of the FDA to place pupil-size restrictions in the device labeling led to improper treatment resulting in visual impairment of many patients.
- The latest technology in LASIK surgery flap creation, femtosecond ophthalmic lasers, received FDA approval under a 510(K) application, bypassing the rigors and scrutiny of clinical trials.Numerous reports of complications associated with this device are found in peer-reviewed literature and in the FDA MedWatch database.
- Since the media coverage of the April 25, 2008 FDA hearing on LASIK, adverse effect reports have surged!According to the FDA there were only 140 reports of adverse effects due to LASIK filed between 1998 and 2006. In 2008 alone, over 500 LASIK adverse event reports were filed. As most LASIK patients are unaware that the MedWatch reporting system even exists, and since the filing process is a visual process that may be inaccessible to many injured LASIK patients, it stands to reason that only a small fraction of adverse events are actually being reported.
- In response to LASIK complaints and allegations of corruption surrounding the approval of LASIK devices, the FDA held a public meeting in April, 2008 to consider patients’ experiences with LASIK.The FDA announced that further study of LASIK dissatisfaction was needed and reported that it had formed an unprecedented partnership with LASIK professional groups to conduct a prospective LASIK study to begin in 2009. The proposed study amounts to putting the fox in charge of the hen house. Surgeons selected to lead the study include those with direct ties to LASIK device manufactures – a clear conflict of interest.
Congress and the American people should be made aware that there are universal adverse effects of LASIK, even in the absence of any immediate clinically relevant complications:
- LASIK weakens the cornea, which may lead to late onset corneal failure.
- The LASIK flap never completely heals and may be accidentally dislodged indefinitely.
- LASIK patients are at life-long increased risk of corneal infections.
- LASIK causes dry eye, which may be permanent.
- LASIK complicates future cataract surgery.
- LASIK invalidates intraocular pressure measurement, which is critical in the diagnosis of glaucoma.
- Excimer laser ablation causes persistent keratocyte (corneal cell) death.
- LASIK can lead to significantly reduced quality of vision, sometimes occurring years after the procedure.
At the present time, there is no technology that will restore a patient’s post-LASIK vision to the same quality experienced before undergoing LASIK surgery. Post-LASIK patients who are no longer able to work leads to additional costs to the US Treasury in the form of disability payments and a loss of revenues from formerly tax-paying individuals.
I believe the FDA Center for Devices and Radiologic Health (CDRH) and Office of Device Evaluation (ODE) has not maintained the distance from the LASIK devices industry required for impartiality. This has resulted in the FDA’s failure to uncover problems, apparent to others, with LASIK surgery.
The FDA should never have approved the use of excimer lasers for an elective eye surgery that was known to be harmful to patients. Congress must correct this error by instructing the FDA to fulfill its regulatory obligation to protect the American public from unsafe medical devices by withdrawing the approval of excimer lasers for LASIK.
Source material for the information discussed above can be provided upon request.
I look forward to a reply at your earliest convenience.
Scott A. Tolchin
Founder, LASIK Surgery Watch Cause on Facebook