"I personally observed that LaserVue physicians Jay Bansal, MD, and his wife, Swati Singh, MD, did not sterilize the microkeratome between patients and did not change the blade between patients."

Leah Holtan

The impending lawsuit against LaserVue has given refractive surgery a black eye, while shining a spotlight on a practice that some physicians say is commonplace around the world. In the lawsuit, filed last summer against LaserVue, attorneys for the plaintiffs assert "fraud, battery, and unfair competition in connection with the center's failure to properly sterilize equipment used to perform LASIK [laser in-situ keratomileusis]."

The suit alleges that Bansal and his associates "willfully and recklessly failed to sterilize the equipment used in the LASIK procedure, and willfully and recklessly reused unclean blades and other surgical products during the surgical procedures in an attempt to maximize their profits by saving expenses and by increasing the number of patients [they] are able to treat in an hour."

The primary concern expressed in the court documents is that the alleged actions may have exposed some of an estimated 2,700 patients and the public to the transmission of blood-borne and other infectious diseases, including HIV and hepatitis B and C. According to informed sources, two former LaserVue patients have tested positive for hepatitis, but it is not known whether they contracted the disease from the LASIK procedure. The attorney for the defense says that experts, including the California Department of Public Health, agree that the risk of any disease being transmitted through these practices was extremely low, and that patients need not be tested.

In September of last year, a preliminary injunction was issued prohibiting Bansal, Singh, and LaserVue Eye Center from conducting any LASIK procedures "without changing the microkeratome blade between procedures and sterilizing the microkeratome between procedures." However, LaserVue claims it voluntarily discontinued the challenged practices in May last year.

On advice of his counsel and because the matter is in litigation, Bansal has not responded to repeated requests for comment from EyeWorld. But, in court documents, he has admitted to reusing blades and microkeratome heads on two patients - after simply rinsing them with sterile water. In fact, the defendants in the LaserVue case do not dispute the fact that they used a single blade for two patients, provided that the first patient had no history of any infectious diseases, there was no bleeding, and the blade performed well. "When a blade was reused on a second patient, it was always cleaned with sterile water and allowed to dry," Bansal's attorneys said in a court filing.

"The standards of care for LASIK are still being worked out and no patients at LaserVue were harmed by this practice," said Fletcher C. Alford, Bansal's attorney. "We believe the evidence will clearly demonstrate that none of the patients experienced any injury whatsoever from the surgical techniques in question. ... From our perspective, this case was brought by several disgruntled employees."

The case against LaserVue became known when a former employee became aware that the center was reusing blades on more than one patient. Leah Holtan, who worked for LaserVue from October 1998 to June 1999, said in court documents, "I personally observed that LaserVue physicians Jay Bansal, MD, and his wife, Swati Singh, MD, did not sterilize the microkeratome between patients and did not change the blade between patients. The microkeratome and blade were reused for surgeries on later patients without sterilization." Holtan said she resigned from LaserVue because of the practice.