The Year 2009 will be remembered as the year that the anti-refractive
surgery community started to win major victories in their war against
LASIK surgery.

fromFDAWeb.com:

FDA acting commissioner Joshua Sharfstein told FDA Webview 5/21 that
he is looking into complaints of many LASIK (laser-assisted in situ
keratomileusis) eye vision enhancement surgery patients that the
agency has failed to honor its commitments to investigate their
complaints since 2006 that the technique has unacceptable risks.

The primary issue in their complaints is that, with an adverse-
reaction risk factor in excess of 5% (patient dissatisfaction) rate
at
six months, nobody is doing research on the procedure’s long-term
quality-of-life. It involves either blade- or laser-cutting of flaps
in the corneal surface layer that patients complain never heal. A
post-
operative trauma to the patient’s head at any time can forever open
the flap and allow the entry of viruses and bacteria to the stromal
layer beneath, with commensurate vision impairment and even
blindness.

According to the injured patients, despite the procedure's 95%
success
rate, the extent of failures exceeds FDA’s allowable 1% limit and the
agency has failed for three years to address petitions submitted
since
2006 that sought enforcement of mandatory adverse event reporting
(MDR) requirements on facilities performing LASIK procedures. They
allege an effective FDA conspiracy with for-profit LASIK surgery
surgeons in concealing true adverse event rates.

In drug and device regulation, FDA is constantly monitoring long-term
risk-benefit issues and addressing them through labeling revisions.
Since LASIK surgery is primarily a practice-of-medicine technology
regulated at state, not federal, level, who is doing the same thing
for these lasers which routinely enter the market without clinical
studies justifying their safety and effectiveness?

FDA’s reliance on its collaboration with the main eye surgeons’
organizations, which have a members’ income conflict-of-interest in
objectively measuring and voluntarily reporting failure rates (only
their physical facilities and the device manufacturers must report to
FDA), is analogous to the outright operational dependency on plastics
and chemical lobbyists that FDA’s Center for Food Safety and Applied
Nutrition developed over many years in regulating the mutagenic and
neurological toxic effects of bisphenol A in food containers,
including baby bottles.

FDA commenters on our Web site are already asserting from this that
industry’s infiltration and takeover of government agencies (not just
FDA) has been an ongoing fact of life for many years, so we better
get
used to it.

Sharfstein’s investigation challenges this assumption.

Then, yesterday:

Days after FDA principal deputy commissioner Joshua Sharfstein
launched an investigation into mounting complaints by injured LASIK
vision-correction patients, one of them 5/25 filed a citizen’s
petition asking for sanctions against LASIK clinics that have not
reported adverse events as required under the medical device
reporting
(MDR) regulation. The petitioner, former Long Island (NY)
restauranteur and LASIK patient advocate Scott A. Tolchin, also asked
the agency to inspect clinics and to “ensure” their compliance with
FDA’s user facility reporting regulation. Tolchin told FDA Webview he
has been on disability for a year due in part to his LASIK-related
problems which worsened since his 1997 surgery.

“Injured LASIK patients allege that the LASIK industry has engaged in
a cover-up of the frequency and life-altering nature of LASIK
complications, such as night vision disturbances and chronic dry
eyes,
and have consistently ignored MDR reporting requirements,” Tolchin’s
liberally documented petition says. “Based on the number of LASIK
MedWatch reports which are self-reported by patients, there is
compelling reason to believe that most LASIK device user facilities
have never filed a single MedWatch report.”

The petition criticizes FDA’s “collaboration” last year with the
American Society of Cataract and Refractive Surgery to study post-
LASIK quality of life. At the time, the society said there had been
only 140 dissatisfied comments from patients in the preceding decade.
“This number, in contrast to the reported incidence of complications
in FDA clinical trials, is a clear indication that LASIK clinics are
not reporting LASIK adverse events as required by law,” the petition
says.

Tolchin says injured patients expressed “harsh criticism” of the
“unprecedented partnership with LASIK professional groups” when they
testified at a 4/25/08 Ophthalmic Devices Panel meeting where a
moratorium on the surgical procedure was requested. “Injured patients
believe that LASIK surgeons are biased and lack objectivity,” his
petition says, “and that the proposed study amounts to the FDA
putting
the fox in charge of guarding the hen house.”

Other issues raised in the petition include alleged multiple reuse by
surgeons of single-use microkeratome blades that cut a flap in the
cornea prior to the LASIK procedure, a reported four-fold increase in
post-LASIK suicides, and a surge in adverse reports from patients and
family members after publicity about the 4/25/08 panel meeting, to
500
in a single year. The petition alleges that despite an FDA
requirement
that all prospective LASIK patients receive a Patient Information
Booklet, LASIK surgeons commonly fail to do this.

“A meta-analysis of Summaries of Safety and Effectiveness for the 12
lasers approved for LASIK from 1998 through 2004 found that six
months
after LASIK, 17.5% of patients report halos, 19.7% report glare,
19.3%
report night-driving problems and 21% report dry eye which are worse
than before surgery, much worse than before surgery, moderately
severe
or severe,” the petition says. Since the first LASIK device approval
in 1998, about 8 million American have undergone the surgery, it
says.

On 5/22, CDRH director of compliance Timothy A. Ulatowski sent a
letter to eye care professionals cautioning them against deceptive or
misleading claims and providing sources of additional information
about intended uses and adverse effects.