02/06/2023    Allen Jacobs, DPM

Class-Action Suits Involving the Cartiva 1st MPJ “Artificial Cartilage” Implant

There are now class-action suits involving the
Cartiva 1st MPJ “artificial cartilage” implant.
Lawyers are seeking clients injured or harmed as
the result of this implant.

While I certainly empathize with those patients who
will limp or forever have an altered gait as the
result of the failure of the Cartiva implant, who
required revision surgery, who incurred the
expenses associated with this, there is another
aspect of this I should like PM News readers to
consider.

1. Anyone with experience performing foot surgery
knew or suspected this implant would fail.
Expecting a small piece of polyvinyl alcohol to
withstand the multiplanar forces of the 1st MPJ was
never a reasonable conclusion by those with
experience. Some of us expressed this concern early
on in PM News.

2. I had taken the time to read the FDA panel
review if the Cartiva implant studies leading to
approval of this device. The conflicts of interest
by the investigators and the mixed conclusions of
the investigators and reviewers in clear to anyone
with insight. Yet, the implant was approved.
Corporate influence is clear. My concern is that of
the ineffectiveness and unreliability of the
approval process. Simply stated, the approval of
devices to enhance surgical outcomes for our
patients cannot be relied upon.

3. This implant was marketed, lectured on, and
endorsed at our post graduate meetings. Again, one
has to wonder whether we can rely upon opinion
leaders and paid consultants or paid lecturers at
our seminars. My thoughts are that the process of
selecting topics and speakers for our CME meetings
must change. We must stop allowing so called
“unrestricted educational grants” to determine the
educational content and speakers at our meetings.
Perhaps “new technologies” should be given some
time for evaluation in clinical use before allowing
speakers to endorse these products at our meetings.

4. You must never forget that the goal of industry
is always first and most importantly to generate
profit. It is not patient safety. Our job is quite
the reverse.

5. There is generally some reluctance of older
podiatrists to quickly adopt new technologies.
While some might argue this deprives patients of
access to such new technology or philosophies
(e.g.: the new MIS surgery push, Lapidus for
everyone, new fixation devices, the plethora of
wound care products), it is also true that some
delay with a wait and watch approach may also spare
our patient from complications and unwanted
sequela.

Allen Jacobs, DPM, St. Louis, MO

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