MENTOR IDE FOR BREAST IMPLANT WITH SILICONE GEL ALTERNATIVE
This article was originally published in The Gray Sheet
Executive SummaryMENTOR IDE FOR BREAST IMPLANT WITH SILICONE GEL ALTERNATIVE is slated for submission to FDA by the end of the year, the company says. FDA approval of an investigational device exemption would allow Mentor to begin clinical studies of implants filled with a proprietary non-silicone gel. Mentor says it is accelerating its development program for the gel, which the firm has been researching for the past several years. European market introduction of breast implants with the new gel is anticipated later this year, according to the company. The alternative gel project has become more important to Mentor in light of a provision in a proposed settlement of silicone gel- filled breast implant class action litigation that requires Mentor to cease marketing the silicone gel-filled devices. The agreement- in-principle, which was announced April 14, would resolve product liability lawsuits filed by patients under multi-district litigation proceedings. It is the first settlement agreed to by plaintiffs and a breast implant firm under a multi-district litigation process ("The Gray Sheet" July 6, 1992, p. 10). The cornerstone of the proposed settlement is a $24 mil. fund that will be established by Mentor and its insurers for distribution to silicone breast implant recipients. According to Mentor, "distribution of the funds will be determined by the" the Federal District Court in Birmingham, Alabama, which is overseeing the multi-district litigation. The court also must approve the agreement-in-principle. Mentor says that a "relatively small" portion of the settlement costs will be covered by its insurance carriers. The company expects to take a one-time charge in the range of $1.15 to $1.30 per share in the fourth quarter of 1993 (ended March 31) as a result of the settlement. The proposed settlement calls for Mentor to "cease marketing silicone gel breast implants within 18 months after the closing of the agreement," Mentor says in an April 14 release. Mentor estimates that the settlement will close in six months to a year, leaving the company two to two-and-a-half years to continue marketing silicone breast implants. Mentor is allowed to sell the devices for use only in FDA-approved studies ("The Gray Sheet" April 20, 1992, p. 1). The firm plans to complete the studies before it withdraws the implants and also will conduct five-year followup required under the FDA protocol. Commenting on the agreement, Mentor Chairman and CEO Christopher Conway said that the firm "denies any wrongdoing or legal liability of any kind. We have settled in order to avoid the costs and risks associated with this type of litigation." The settlement "is in the best interests of the company" and "will allow Mentor to move beyond this controversy and concentrate on the future." Mentor is the only firm currently selling silicone breast implants in the U.S. The firm estimates that silicone breast implant sales contributed less than 10% to the company's fiscal 1993 worldwide revenues of roughly $115 mil. In addition to distributing the implants in the U.S. under clinical trials, Mentor is selling the devices in a number of overseas countries. Margaret Moses Branch, an attorney with the multi-district litigation plaintiffs steering committee, commented that the steering committee is "very pleased that because Mentor has acted responsibly, the company's limited resources will not be dissipated in prolonged litigation, and we are able to deliver the optimum benefit...to women who have Mentor implants," according to a separate April 14 release jointly issued by Mentor and the committee. She added that under the settlement, women with Mentor implants "will still have a claim against Dow Corning because Dow Corning supplied Mentor with the gel used in the implants." Other multi-district litigation defendants include McGhan, Bristol Myers-Squibb unit Surgitek, Cox-Uphoff International and Baxter Healthcare. McGhan is the only other firm that has not officially withdrawn from the silicone breast implant market. In October 1992, FDA granted McGhan permission to provide implants to a limited number of women who already had received the firm's tissue expander ("The Gray Sheet" Nov. 2, 1992, p. 7). The firm says it has completed this process. McGhan is otherwise barred from selling silicone implants because it is out of compliance with good manufacturing practices.
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