Posts filed under 'Press Releases'
Jenna Reed and Rian Reed vs. Alcon Laboratories, Inc., Alcon Manufacturing, Ltd., and Alcon Refractive Horizons, Inc. United State District Court, District of Colorado.
Denver, CO (LASIK Newswire) August 24, 2008 — On August 20, 2008, plaintiffs, Jenna Reed and Rian Reed, filed their complaint in the United States District Court, District of Colorado, seeking damages against Alcon for strict liability, negligence, breach of warranty, misrepresentation, and violation of the Colorado Consumer Protection Act. Case Number 1:08-cv-01759-EWN Reed et al v. Alcon Laboratories, Inc. et al Complaint.
LASIK eye surgery is among the most prevalent forms of elective surgery performed in the United States. It is estimated that it is performed on approximately one million eyes per year. The LASIK industry generally, and defendants in particular, profess that the surgical laser systems used to perform the surgery are safe. However, on February 21, 2007, the United States Food and Drug Administration recalled defendants’ excimer surgical laser system, known as the LADAR6000 Excimer Laser (the ALADAR6000) due to reports that the LADAR6000’s CustomCornea Myopia and CustomCornea Myopia with Astigmatism algorithm procedures were causing Acentral islands in patients.
Unfortunately for the plaintiff Jenna Reed, a 33 year old wife and mother of two, who resides in Longmont, Colorado, the FDA Recall came too late. She was one of approximately 20 patients who were injured by the defective LADAR6000, which was used by her LASIK surgeon at Insight LASIK, in Layfayette, Colorado.
On September 22, 2006, Mrs. Reed’s doctor performed LASIK surgery on her, and programmed the LADAR6000 to perform CustomCornea Myopia with Astigmatism on Jenna Reed.
Predictably, Jenna Reed has developed Acentral islands, which are a laser created defect in her eyes caused by the laser’s uneven application of energy to her corneas. As a consequence of resultant peaks and valleys in her corneas, Jenna Reed is left with a permanent visual disability marked by problems with her vision, which include, without limitation, blurring, ghosting, double vision, photosensitivity, poor night vision, and ocular headaches.
Defendants have offered to send Jenna Reed, and numerous other patients injured by its defective LADAR6000, to Texas for purported corrective surgery. However, Jenna Reed’s eye care professionals at InSight (who are not the subject of this lawsuit) have advised her that there is no certainty that any further surgery can cure or correct her injuries.
The plaintiffs are represented by Carrie Frank of Klein | Frank, P.C., in Boulder, Colorado and Todd J. Krouner, from Chappaqua, New York. Mr. Krouner and Ms. Frank have also filed suit on behalf of another patient, Melanie Wheeler, of InSight who was also injured as a result of the defective LADAR6000. Klein | Frank, P.C. is a nationally recognized firm that handles cases involving defective products, personal injury and defective drugs throughout the United States.
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Contact Information
Carrie Frank
Klein | Frank, P.C.
http://www.lawcolorado.net
303-448-8884
August 24th, 2008
FOR IMMEDIATE RELEASE
July 15, 2008
Corneal ectasia; thousands of late onset complications of LASIK likely
LASIK surgeons fail to comply with FDA reporting requirement
After recklessly performing millions of LASIK surgeries over the past decade with little to no policing of its poor surgical practices and deceptive advertising, the LASIK industry is feeling the pinch. LASIK volumes have plummeted after a flurry of bad press and public outcry of widespread problems with LASIK. But this doesn’t help the patients who have been needlessly harmed by an unnecessary, irreversible surgery.
When a patient suffers a complication of LASIK, the surgeon is required to file a MedWatch report with the FDA. In a press release earlier this year, the LASIK industry stated that only 140 reports had been filed with the FDA “relating to LASIK dissatisfaction” between 1998 and 2006. In issuing this statement, the LASIK industry admitted that LASIK surgeons routinely fail to comply with FDA reporting requirements. In fact, it appears that most LASIK surgeons have never filed a single MedWatch report.
The LASIK industry received Food and Drug Administration (FDA) approval to perform a destructive surgery on healthy eyes based on sloppy science and insufficient, short followup data. LASIK causes chronic dry eyes and poor night vision in approximately 20% of patients, according to a review of FDA clinical trials. These “symptoms” were not disclosed to prospective patients, even though they can be permanent and life-altering.
But one complication of LASIK has the industry concerned because public awareness of the sight-threatening complication, corneal ectasia, could further tarnish the image of LASIK. Ectasia is a progressive forward bulging of the cornea, which requires corneal transplantation in most cases. Ectasia strikes when the cornea is too weak after LASIK to withstand the stress of the intraocular pressure of the eye. Medical studies show significant, permanent weakening of the cornea after LASIK in all eyes, which may lead to ectasia years after surgery.
The incidence of ectasia is estimated to be approximately 1 in 2,500 but this number could be an underestimate due to underreporting and lack of long-term followup after LASIK. Approximately 8 million people have undergone LASIK in the United States, likely resulting in thousands of unreported cases of post-LASIK ectasia.
Failure of the FDA to order long-term followup of LASIK patients (post-market surveillance) and enforce MedWatch reporting of LASIK complications is to blame for lack of public awareness of the potentially blinding complication of post-LASIK ectasia. But patient groups are watching, and they want the FDA to know that they will hold the Agency accountable.
July 15th, 2008
Reports of LASIK complications to the FDA’s MedWatch program (MAUDE Database) for medical device adverse events have nearly doubled since the public announcement of the the April 25th, 2008 Special Hearing of the Ophthalmic Devices Panel, held to discuss post-LASIK quality of life, depression, and suicide. At the hearing, two medical doctors, two optometrists, three psychologists, and a number of injured patients presented compelling information establishing a causal link between bad LASIK, depression, and suicide. Excerpts from two suicide notes were presented, including that of a medical student (video: http://www.youtube.com/watch?v=UX855jmViaM) and that of a police officer who was well respected in his community (video: http://www.youtube.com/watch?v=PBAqnVfJ5GU).
Over the past decade since LASIK was FDA-approved, the Agency has failed to enforce physician reporting of adverse events. In March and April, 2008, patients were made aware of the voluntary reporting option by media reports of an upcoming FDA Special Hearing on LASIK problems.
The recent, rapid growth of complaints in the MAUDE database is, presumably, particularly embarassing for the American Society of Cataract and Refractive Surgery (ASCRS). In its April 7th, 2008 press release, ASCRS attempted to spin public perception of the Special Hearing by stating that “Between 1998 and 2006, the FDA received a total of 140 comments relating to LASIK dissatisfaction, representing less than 1 in 10,000 U.S. LASIK patients.” Unfortunately for ASCRS, nearly twice as many complaints have been received in the last six months as in the last ten years since LASIK’s approval.
The growth of complaints is also embarassing for the FDA, since some patients at the meeting charged that they are victims of an ongoing medical coverup, perpetrated by collusion between ASCRS and the FDA. Indeed, in its April 7th, 2008 press release, ASCRS stated that “The FDA reaffirms that LASIK is both safe and effective.” LASIK critics have responded to this assertion by asking publicly “When exactly was ASCRS authorized to make public announcements for the Food and Drug Administration?”
Three other sources of information suggest collusion between ASCRS and FDA. First, prior to the Special Hearing, patients who came to the FDA’s website were encouraged to use a comment form to report their vision issues and dry eye complaints to the FDA. Unknown to patients, these complaints were held by FDA Center for Devices and Radiological Health (CDRH), but were never registered in the MAUDE reporting system. Neither were they reported in the April 7th ASCRS press release. Why did the FDA CDRH choose to suppress these complaints? Was it to make LASIK look safer than it really is? Even though LASIK surgeons are required to report adverse events from LASIK to the FDA, most surgeons have apparently never filed a single MedWatch report, despite the fact that ASCRS admits that up to 5% of patients are dissatisfied with their results.
Second, compare the ASCRS press release with a 2006 document issued by the FDA CDRH at http://www.fda.gov/cdrh/postmarket/mdpi-report-1106.html. In this document, CDRH states frankly that “The data that are submitted via MDR rely upon a generation-old software platform (MAUDE) to organize, store and allow management of the data. This software, due to its age and limitations, does not allow MDR to serve its customers well. FDA staff and stakeholders report that MDR…does not provide timely and usable data to staff or other system users…[and]…has a large backlog of reports which hampers the ability to detect signals or identify problems.” Obviously, this document establishes that the FDA has long been aware of deficiencies in the MAUDE reporting system. Why, then, did the FDA allow ASCRS to speak for the agency? Why was ASCRS allowed to publicize deficient and inaccurate information in order spin public perception about the safety of LASIK? If the MAUDE system was known to be broken, why were complaints issued to the agency through its LASIK comment form never counted?
Third, according to an article in the June 2008 issue of Cataract & Refractive Surgery Today, in November 2006, the same month the FDA released criticism of its MAUDE reporting system, the FDA approached ASCRS and American Academy of Ophthalmology (AAO) to form a Joint LASIK Study Task Force in response to complaints sent to the FDA and Congress by damaged LASIK patients. Apparently, ASCRS surgeons had over 1.5 years notice of FDA’s intention to call a Special Hearing for LASIK post-market issues. In contrast, medical doctors, optometrists, psychologists, and injured patients who spoke on behalf of thousands of LASIK victims were not aware of the planned hearing until it was publicly announced in the Federal Register at the end of March, 2008. These individuals had just one month to prepare. Why did the FDA give the LASIK industry 1.5 years notice of the Special Hearing while patient groups and the public had only a one month notice?
Patient advocates want answers to these questions. So do thousands of damaged LASIK patients.
June 16th, 2008
FOR IMMEDIATE RELEASE
SynergEyes
2232 Rutherford Road
Carlsbad, CA 92008
Ph: 877-733-2012
Fax: 877-329-2012
Contact:
Kellie Kaseburg
Vice President of Global Marketing
kkaseburg@synergeyes.com
877.SEE.2012
SynergEyes Hybrid Contact Lenses Provide a Vision Solution for Post-LASIK Patients
San Diego, CA (April 25, 2008) – SynergEyes, Inc., of Carlsbad, CA, recently launched a revolutionary hybrid contact lens designed for people who need further vision correction after undergoing refractive vision surgery. SynergEyes® PS (post-surgical) is also designed for patients who have experienced some type of corneal trauma or suffer from certain degenerative vision conditions.
Every year, millions of people undergo LASIK or other types of vision correction surgery to restore vision and eliminate the need for glasses or contact lenses. But according to the U.S. Food and Drug Administration (FDA), approximately 5 percent of LASIK patients are dissatisfied with their outcome and experience post-operative conditions like eye pain, blurred or double vision and difficulty driving at night.
Because LASIK permanently alters the shape of the eye, traditional contact lenses and glasses often cannot provide the additional vision correction needed. This is why SynergEyes has developed a revolutionary contact lens designed specifically to address the technical challenges of restoring vision to these patients offering them consistent, predictable vision, even at night.
Approved for marketing by the FDA, SynergEyes® PS hybrid contact lenses combine two materials — a rigid gas permeable center with a soft lens outer skirt. The “hybrid” design bonds a “hard” and “soft” contact lens together resulting in a one-of-a-kind vision correction option that provides crisp, clear vision for surgically altered corneas in a comfortable, healthy contact lens.
“The SynergEyes® PS lens has proven to be a safe, effective and comfortable lens for the restoration of post-surgical vision loss,” says Dr. Edward Boshnick of Miami, Fl. “It has become my first choice lens for the treatment of patients who have lost quality vision and comfort due to refractive and corneal transplant surgery.”
Until being fit with SynergEyes® PS, Gabriel Meneses, a patient of Dr. Boshnick, had been struggling daily with post-LASIK side effects like blurry vision, ghosting and migraines after having the surgery six years ago. His vision could not be adequately corrected with eyeglasses or other contact lenses. “Dr Boshnick gave me the opportunity to be one of the first to try the new SynergEyes® PS lens…all I can say is what a difference! As for vision quality, this lens has definitely offered me the best I’ve experienced so far.”
Incorporating patented HyperBond™ technology and HydrolEyes™ surface science, the SynergEyes contact lenses with FDA market clearance include SynergEyes® A for naturally occurring ametropia, targeting patients with astigmatism, current gas permeable lens wearers, and patients demanding optimized vision; the SynergEyes® KC for keratoconus, the SynergEyes® Multifocal lens for presbyopia and the SynergEyes® PS for post-surgery and post trauma refractive errors.
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May 6th, 2008
LASIK is a 2.5 billion dollar per year industry. LASIK is considered by some as the “gravy train” of ophthalmology. Recently many questions have been raised about the frequency and severity of complications, and now many are wondering if LASIK really lives up to the hype.
In the past decade, several lasers have received FDA approval for use in LASIK surgery. A report of data from FDA clinical trials for LASIK, including current technology, reveals that approximately 20% of patients report complications.1 The report shows that six months after LASIK, 17.5 percent of patients reported halos, 19.7 percent reported glare, 19.3 percent had night-driving problems and 21 percent complained of dry eyes. It appears that if FDA had properly classified these “symptoms” as adverse events or complications, the devices would have failed to meet safety requirements for approval.
The FDA’s MedWatch program allows healthcare professionals and consumers to report adverse events associated with medical devices, such as those used to perform LASIK. However, patients are not informed about the MedWatch program and there is no enforcement of reporting by physicians. The inconsistency between the reported complication rates from LASIK clinical trials and the number of adverse events reported to the FDA through the MedWatch program clearly shows that complications from LASIK are grossly underreported.
Reports of widespread, serious problems with LASIK prompted FDA to hold a post-market meeting on April 25, 2008 to hear patient complaints and to accept recommendations from a panel of experts. The panel was chaired by LASIK surgeon, Dr. Jane Weiss. In her closing remarks, Dr. Weiss blamed the problems on “some surgeons who should be doing a better job”, rather the surgery itself. Patients felt the hearing was a sham.
Two weeks before the FDA hearing, the American Society of Cataract and Refractive Surgery (ASCRS), a 10,000 member strong organization of ophthalmic surgeons, issued a press release stating the organization had formed a joint task force with FDA, National Eye Institute (NEI), and the American Academy of Ophthalmology (AAO) to conduct a prospective post-LASIK quality of life study. The timing of the press release seems to indicate that the LASIK industry had inside information that the FDA had no plans to act swiftly on recommendations from the public at the hearing. The unprecedented partnership between the LASIK industry and the FDA has raised eyebrows in the patient community.
These events followed on the heels of media reports of patients who experienced depression, and a report of suicide, due to complications from LASIK. ASCRS fired back at the North Carolina newspaper that broke the story in February. A flurry of bad press for the LASIK industry followed. By early March, the LASIK industry had launched its damage control campaign by releasing preliminary findings from a meta-analysis of LASIK studies, which showed a 95% satisfaction rate. Patients consider this meta-analysis a smokescreen to conceal the high rate of complications, such as dry eyes and night vision impairment. Four suicides and numerous cases of depression related to LASIK were reported at the FDA hearing.
LASIK industry leadership subsequently announced the names of doctors who were hand-picked to design and conduct the post-LASIK quality of life study with the task force. One of the doctors selected for the study is a well-known defense expert witness who testifies against LASIK patients who file medical malpractice lawsuits, has financial ties to the LASIK industry, and has made public statements that LASIK complications do not lead to depression. Patients believe that all of the doctors chosen for the study are biased and lack objectivity, and that the study as proposed amounts to “the fox guarding the hen house”.
In a National Public Radio interview this week, Mary Weick-Brady, an FDA spokesperson, encouraged patients to report LASIK complications to the Agency using the MedWatch program. Weick-Brady stated that halos, starbursts, and problems with night vision are considered adverse events.
The question that many damaged LASIK patients now want the FDA to answer is, how did a medical device with a 20% rate of adverse events receive FDA approval in the first place?
Reference:
1. Bailey MD, Zadnik K. Outcomes of LASIK for myopia with FDA-approved lasers. Cornea. 2007 Apr;26(3):246-54.
May 4th, 2008
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