Device maker ReGen Biologics took exception to the plans by the
FDAs Center for Devices and Radiological Health (CDRH) to rescind 510(k)
clearance for Menaflex.
The FDA announced October 14 it is rescinding its December 2008 510(k)
clearance of the Menaflex collagen meniscal implant manufactured by ReGen
Biologics Inc. (Hackensack, N.J.,) following an in-depth re-evaluation of the
ReGen Biologics Chairman and CEO Gerald E. Bisbee Jr., PhD, stated in a
press release issued the day of the announcement, The company is
currently weighing its options. The product has been approved and in use
successfully in Europe for nearly 10 years with approximately 3,000 patients,
and there has never been a safety issue associated with the device.
FDAs re-evaluation process followed a September 2009 agency report
that identified problems with the agencys review of the device and called
for a second look at the scientific data for the implant, according
to an FDA press release. As a result, the FDA now concludes the device is
intended to be used for different purposes and is technologically dissimilar
from devices already on the market, what it calls predicate devices. These
differences can affect the safety and effectiveness of the collagen implant,
the agency noted.
In recent months approval of the Menaflex implant came under fire from
Sen. Charles E. Grassley (R, Iowa) and was the focus of a special FDA
orthopedic advisory committee meeting in March at which experts reviewed
scientific evidence for the device, which has been used worldwide to repair and
reinforce meniscal tissue in the knee.
Bisbee said in a second ReGen press release on the topic that politics,
not science drove FDAs latest decision. For CDRH [Center for
Devices and Radiological Health] to arrive at the decision that the device has
a new intended use 4 years after two senior CDRH officials informed the company
that the device could be reviewed through the 510(k) program is totally
unbelievable, he stated. Even more incredible is that they arrived
at that conclusion after the second Orthopedic Advisory Panel of independent
experts chosen by FDA was specifically asked about the intended use of the
device and confirmed that it functioned like predicates.
Champ L. Baker, Jr.
Those reacting to the announcement included Champ L. Baker, Jr, MD,
FACS, of the Hughston Clinic, in Columbus, Ga., and Menaflex inventor and ReGen
co-founder, Kevin R. Stone, MD, of the Stone Clinic, in San Francisco.
Baker, who has researched and used the implant, told Orthopedics
Today, Im sorry the Menaflex seemed to have gotten embroiled
in a political battle. I am convinced that the implant is safe and I felt it
was efficacious. However now that it is no longer available, those patients
will either have to accept their meniscus loss or some can be operated on with
According to Stone, who is not directly involved with the device, said
The FDA-company sequence of events was a tragedy for everyone involved,
particularly for patients. There is no other alternative for meniscus
In addition to information that came out when FDA announced its decision
to rescind approval of the Menaflex device, the agency identified in a
September 2009 report and its addenda several of its departures from processes
and practices that occurred over the years during CDRHs review of the
As reported, those departures included:
- FDA took at face value ReGen officials complaints of unfair
treatment without a full investigation;
- New Jersey politicians reportedly influenced how the FDA approached
the products review;
- a full scientific review of the scaffold may never have been
- ReGen had atypical access to two FDA officials, the commissioner and
principal deputy commissioner, during meetings with the FDA; and
- prior to the November 2008 orthopedic panel meeting, the commissioner
pressed for rapidly convening the panel and in a procedural irregularity
reviewed the panels constitution.
Process to begin
To correct these errors, FDA said it will begin for the first time ever
a process to rescind the products marketing clearance, and has asked to
meet with ReGen Biologics officials before that time, to discuss the
appropriate marketing pathway for the device and what data the agency would
need to provide a reasonable assurance of safety and effectiveness.
Based on information in the FDA release, explantations of Menaflex
devices in U.S. patients will unlikely be necessary since the device is
resorbed and replaced with new tissue. However, the FDA said patients treated
with the device should discuss the situation and what steps should be taken
with their surgeon or another health care professional.
A rescission is an FDA action to revoke marketing clearance later
determined to be erroneous. After it is implemented, the manufacturer is
prohibited from further marketing the device in United States until the agency
approves or clears it under a new application or grants a classification
petition. After the FDA issues a rescission notice, a manufacturer has the
option of requesting a regulatory hearing with the FDA or can choose to
voluntarily withdraw their marketing clearance. The device will remain on the
market until the agency rescinds its clearance, according to the FDA release.
The circumstances surrounding the Menaflex device are unique, and the
FDAs decision in this case does not impact the status of other products
on the market, the agency noted.
In Bakers opinion, reversing clearance of the Menaflex device is
based not on the products merits, but on how it was presented. No
evidence was ever presented that it wasnt safe, he said.
The company and the FDA both failed in their ability to deliver a
safe technology to the marketplace, Stone told Orthopedics Today.
The company, by following an inadequate testing and FDA strategy, and the
FDA. by failing to leave the product on the market given that there has never
been a safety issue. It should have, in my view, required a post-market
surveillance study to determine the products efficacy.
Stone has followed his original patients who received his collagen
meniscus implant for more than 15 years and they are doing well, he said. He
noted he used the Menaflex implant in a number of patients successfully since
the FDA approved it. by Susan M. Rapp
- Champ Baker, Jr., MD, FACS, can be reached at 6262 Veterans
Parkway, Columbus, GA 31908; 706-324-6661; e-mail:
Baker is former advisory board member for and received travel expenses and
miscellaneous support from ReGen Biologics.
- Kevin R. Stone, MD, can be reached at 3727 Buchanan St., San
Francisco, CA 94123; 415-563-3110; e-mail:
email@example.com. As the company co-founder, Stone
retains some founders shares of ReGen Biologics stock. As the company
co-founder, Stone retains some founders shares of ReGen Biologics stock.
I think the FDA is making a statement that they will not be prey to
external influences. Menaflex is an index case whereby the FDA is raising the
bar on its 510(k) process. ReGen may appeal this, and there is no cause for the
public to be alarmed as safety was never a real issue.
John D. Kelly IV, MD
Pennsylvania, Department of Sports Medicine Philadelphia, Pa.
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