WASHINGTON (March 19, 2010)--Regen Biologic, a medical device company at the center of a controversial approval decision by the Food and Drug Administration, is pushing back against the agency's plan to review the implant.

Regen Biologic's knee repair device spent more than three contentious years under review at the FDA before gaining approval in 2008.

When FDA officials reviewed the process last year, they concluded intense lobbying by lawmakers from Regen’s home state of New Jersey influenced staffers.

Next week the FDA will ask a panel of experts to reassess the device's safety and effectiveness, an extremely rare step for a device that’s already on the market.

Regen said in a statement the meeting is "unprecedented," and "has no legal basis."