Menaflex - Torn Meniscus

ALICIA MUNDY
WASHINGTON -- The Food and Drug Administration said it will re-examine its decision to approve a knee-surgery device last December over the objections of several scientists and managers at the agency, according to a letter from the FDA that the Senate Finance Committee reviewed Monday.

The letter, signed by acting FDA Commissioner Joshua Sharfstein and reviewed by The Wall Street Journal, said the controversy over the decision raises "legitimate concerns about whether the agency's review process and decision...were compromised."

The device, called Menaflex, is made by ReGen Biologics Inc. of Hackensack, N.J. It is designed to help patients who have severely torn meniscus tissue in their knee joint recover long-term mobility and avoid degenerative arthritis.

Resources
House Energy and Commerce Committee letter to the FDA More on ReGen
Political Lobbying Drove FDA Process
03/06/2009 Donations Preceded FDA Shift
04/07/2009 The House Energy and Commerce Committee on Monday, in a separate action, asked the FDA to re-examine the ReGen decision. In a 16-page letter to the FDA, committee leaders said that agency documents "raise concerns" about an advisory panel of orthopedic-surgery experts convened by the agency last November.

The House committee's letter cited issues "such as the exclusion of FDA experts who had raised concerns previously about the device, the propriety of ReGen's input into the selection of advisory committee members, and the failure to hold a formal vote on whether the device should be approved."

Gary Bisbee, ReGen's chief executive, said through a spokeswoman that the FDA made the right move in overruling the negative views of some agency officials and approving the device in December. He said the FDA's earlier rejections were based on an "illegal comparison of the device to a surgical procedure" instead of other cleared medical devices. ReGen says Menaflex is safe and effective.

Dr. Sharfstein's letter was sent to the Senate in response to questions from Sen. Charles Grassley of Iowa, the ranking Republican on the Finance Committee. The Wall Street Journal carried a page-one article on the Menaflex approval process in March.

Menaflex was cleared by the FDA using a fast-track method that doesn't require major clinical trials on safety and efficacy. That process is now under scrutiny by Congress because of allegations from FDA doctors and former FDA commissioners that it has been used too often in recent years to approve devices that need more clinical trial information.

Rep. Bart Stupak (D., Mich.), who is chairman of the investigations subcommittee of the House Energy and Commerce panel, has been looking into allegations involving the FDA's device division. He signed the committee's letter to the FDA along with its chairman, Henry Waxman of California, and Frank Pallone of New Jersey, the health subcommittee leader.

Rep. Pallone was among several New Jersey Democrats who repeatedly pressed the FDA to move swiftly on the Menaflex application in late 2007 and 2008. The Democrats cited complaints repeatedly raised by ReGen in which the company said FDA officials were biased against it. Those contacts were detailed in internal FDA memos and confirmed by the lawmakers' aides.

Rep. Pallone has previously said through an aide that his contacts with the agency were proper and that he was only trying to ensure that ReGen was given fair treatment. On Tuesday, Mr. Pallone will hold a hearing in his subcommittee on legislation he has co-sponsored which would allow victims of flawed medical devices broader latitude to sue their makers.

Cartilage is about 100 times more slippery than ice

Sitting at Joe Louis Arena several weeks ago, I spent intermission avoiding concession lines and let myself become hypnotized as the Zamboni transformed the beat-up ice into a glistening, smooth surface once again. Then the Wings came out and promptly carved it up (and unfortunately were also carved up in OT by Calgary). Watching the players and the puck glide across the ice made me wonder how there could be a substance smoother than ice. Indeed there is, and it's a part of the human body.

Cartilage is a substance that coats the ends of each bone, where one bone meets another to form a joint. Normal cartilage has a coefficient of friction two orders of magnitude lower than ice — simply put, cartilage is about 100 times more slippery than ice. This is what allows each joint to move smoothly over the course of a lifetime — hopefully. Imagine how many times you bend and straighten a finger during the course of a lifetime and imagine how smooth that movement remains through the years. Cartilage is indeed a very unique and important material in the human body and damaged cartilage can cause major problems.

Injuries to cartilage occur commonly in athletes, typically in noncontact injuries of the knee. Although the injury itself does not involve contact, there is usually a violent collision inside the knee between the two smooth joint surfaces which can damage the cartilage and even break a piece off. This can also occur in the ankle with a severe sprain or in the thrower's elbow as a result of repetitive, forceful use of the arm.

Standard first-line treatment of this problem involves the “microfracture” procedure which has become such a dirty and dreaded word in professional sports. In reality, the procedure and the rehab are very simple though recovery is lengthy. The dread lies not in the procedure but in the nature of the injury as, once the smooth cartilage surface is damaged, the body lacks the ability to repair it. These dents or craters are generally small areas of the otherwise normal joint surface, analogous to a pothole on an otherwise well-paved road.

Microfracture is a minimally invasive arthroscopic procedure in which small, two-millimeter punctures are made in the defect left behind when the smooth cartilage covering the bone is lost. The goal of the surgery is to stimulate “scar” cartilage to fill in the defect from the holes that are punched in the base of the pothole. This scar cartilage is not normal but can often do an adequate job, similar to the asphalt used to repair small potholes in the road. If the joint pothole is extremely large, more extensive surgery is usually required.



Until recently, the only way to absolutely repave a damaged area of cartilage was to repave it with a brand new surface, namely a joint replacement. Joint replacement would be a colossal overkill for these injuries but the potholes also are too problematic to be ignored.

A recent development in cartilage surgery is a technique in which the patient's own cartilage is harvested, grown in a laboratory and then reimplanted into the defect. While microfracture is still considered the best first line of defense for cartilage injuries, it is now routine to take a sample of the patient's cartilage at the time of the microfracture to hold in a tissue bank should the microfracture fail to provide relief. It is essentially an insurance policy for the cartilage. Although it is still considered experimental by some insurers, this potent new procedure is now thought of as the most reliable way to replace and repair damaged areas of cartilage and will continue to be refined at least until a Zamboni machine for the knee is developed.

Dr. Sean Bak is a Novi resident and an orthopaedic surgeon who specializes in sports medicine and shoulder reconstruction. Dr. Bak takes care of the athletes of several area universities and high schools. His practice, Porretta Center for Orthopedic Surgery, is located at the Novi Orthopaedic Center on the campus of Providence Park Hospital

A jury awards a western Wisconsin teacher more than $350,000.

River Falls (WQOW) -- A jury awards a western Wisconsin teacher more than $350,000. The verdict came down last week more than four years after Ryan Bishop was injured at River Falls High School.

Bishop is a physical education teacher at the high school. He's also the baseball coach. According to a newspaper in Red Wing, Minnesota, Bishop was doing some work near the gym in 2004 when a motion sensor shut off the hallway lights. That article shows he tripped on the edge of a 'jump rope rack' and fell down. Court records show, he waited to go to the doctor for more than two months, but once he did, he was diagnosed with torn cartilage in his knee and a herniated disc in his back.

Those sensors were supposed to turn off the lights if no movement was detected, but Bishop claims he and other teachers had complained the sensors were malfunctioning. He also claims contractors never fixed the problem. Bishop filed a civil lawsuit, and last week the jury's verdict was handed down.

The jury awarded Bishop and his wife more than $363,000 -- much of that to pay for future medical care. The jury found the general contractor for the school, a company out of Waupun, was more 50% negligent for what happened, B&B Electric, out of Eau Claire, was 28% negligent, and the high school was 15% negligent.