Texas Menaflex Knee Attorney
FDA Says ReGen Provided Inadequate Data on Knee Device
By ALICIA MUNDY And JARED A. FAVOLE
WASHINGTON (March 20, 2010) - The Food and Drug Administration ("FDA") said ReGen Biologics Inc. hasn't provided adequate data to show that its knee device is safe, and the company didn't completely follow FDA guidelines, according to agency documents released Friday.
The FDA also has concerns about whether it was appropriate for New Jersey-based ReGen to compare its device with other products that are used to repair the shoulder, a hernia, or the bladder. Companies often can get a faster FDA approval process if they are able to show that their product is similar to devices already on the market.
"Overall, the FDA believes that [ReGen] did not provide adequate pre-clinical mechanical testing data to clearly demonstrate safety against mechanical failure," the agency said.
The FDA's statements were released ahead of an advisory committee meeting of outside orthopedic surgery experts Tuesday. The agency is in the middle of an unusual re-evaluation of ReGen's Menaflex knee implant, which was cleared for use in December 2008 by the head of the device division over the objections of a number of agency scientists and managers.
In materials ReGen has submitted for the meeting, the company said its knee repair device, which is on the market, is safe and beneficial, and that it is substantially equivalent to several other surgical meshes on the market. The company's chairman, Gary Bisbee, said in a statement that ReGen continues to express concern to the FDA about the "fundamental unfairness" of the coming meeting, "and the way the panel has been approached by the FDA."
A Wall Street Journal article in March 2009 revealed that there had been pressure on the FDA from four Democratic members of New Jersey's congressional delegation and lobbying by ReGen executives and lawyers to get the device cleared.
After the article appeared, the agency, under its new deputy commissioner, Joshua Sharfstein, began an investigation of the FDA's handling of the approval process. In September 2009, the FDA released a report criticizing its own decision-making, saying the agency had bowed to "extreme" pressure from Capitol Hill, and that the integrity of the approval process had been damaged.
The FDA also described some interactions with ReGen as "adversarial."
A ReGen spokesman has said that the company needed to be aggressive in order to receive fair treatment for the device's approval application.
Dr. Sharfstein announced that the FDA would begin a completely new review of the ReGen implant.
ReGen reacted strongly to the report at the time, saying it didn't adequately evaluate the scientific evidence supporting the knee device.
In its submission to the FDA on Friday, the company stated: "We have not been informed about the issues you are being asked to consider, and are providing you an extensive summary describing the clinical data that supported its clearance by FDA."
In early testing, ReGen compared its knee device to surgical meshes used to repair injuries to other parts of the body. The FDA is concerned about such comparisons because, for example, the weight stress on the shoulder is less than that on a person's knee. The agency also said it is difficult to analyze some of the actual clinical data from testing on humans because the company didn't present it according to recognized guidelines and didn't follow certain study protocols
ReGen's documents say that the FDA's earlier report didn't raise safety questions about the Menaflex.
Consumer advocate Sidney Wolfe said there is no reason for the knee device to remain on the market. His group, Public Citizen, opposed its approval in 2008.
Help for Knee Replacement Patients
Hundreds of people who received a ReGen Menaflex knee implant now face a painful reality - the products in their bodies may be defective and need to be replaced. If you have a ReGen Menaflex knee implant in your body, you should speak with your doctor. Symptoms of defective implants include pain and reduced mobility.
Then contact Hughes Ellzey, LLP, at 1-888-350-3931.
You should also complete the ReGen Menaflex Knee Implant Client Questionnaire and return it to our office as soon as possible. The ReGen Menaflex law firm of Hughes Ellzey, LLP is seeks to obtain compensation for individuals who received the ReGen Menaflex defective knee implant. ReGen knee implant lawyer W. Craft Hughes will work to help you obtain the compensation you deserve. This compensation can include money for replacement surgery, related medical bills, physical therapy, lost of income and pain and suffering.
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