Tag Archives: xiaflex

Is the DCI treatment for Dupuytren contracture a lifetime correction?

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i saw a dr. yesterday.   he wants to use the needle procedure xiaflex.  after reading DCI information on your website i’m not sure which way to go.  if i use the alternative method is it a lifetime treatment?
Greetings,

Good question. 

At this time we have been working with people for only 10 years using Alternative Medicine treatment of Dupuytren contracture.  During that time DCI has helped many hundreds of people from around the world improve and overcome their hand contracture problem.  And during that time I have not had anyone come back later to say their Dupuytren contracture returned – no one .    This either means that people have had their DC come back but they have not told me about it, or it means that their DC has not returned.  I cannot say for certainty which it is because we are not capable of doing follow up studies at this time of those people who report improvement of their hand problem.

Injection with Xiaflex to treat Dupuytrens is not perfect; there are inherent risks and problems that occur.  While the rate of Dupuytren recurrence after Xiaflex injections is less than after surgery, the hand problem does recur.   The makers of Xiaflex hold this finding up to indicate that this means the recurrence rate is low.  I think the Xiaflex rate of Dupuytren recurrence is not actually low; it is just not as high as after surgery.   Because these injections only make temporary changes to the hand at the specific site of drug action, you will eventually have to do the Xiaflex injections again and again.  Actually what they are finding out is that the rate of recurrence of Dupuytren contracture after Xiaflex injections will increase each time you have the injections.  This means that the more you use Xiaflex for your hand, the faster it will come back.   Each time you use Xiaflex you expose yourself to the risk of accidents and drug reactions in which blood vessels, tendons, nerves, and muscles can be permanently damaged.  For more information please read, “What is Xiaflex and what are the risks if I take it?” and “Do Xiaflex injections really have a low recurrence rate?“

I cannot tell you what you should do.  But I can tell you that you should spend some time learning the pros and cons of this new procedure and fully understand what it is all about.  As a suggestion, you should consider trying a brief therapeutic trial of Alternative Medicine treatment, perhaps for a month or two,  such as you see on the DCI website to see if you can respond favorably to conservative care.  If it helps you as it has helped many others, you might not have to consider any drug or surgical treatment.  If it does not help you, you can go into a drug or surgical treatment knowing that you have tried to be conservative first and now you are ready for more radical treatment.   TRH

How many lawsuits for Xiaflex used to treat Dupuytren’s contracture?

Posted on by STL314
Lawsuits for Xiaflex are never easy
26 Jan

Lawsuits for Xiaflex difficult to count

“How do I find out how many lawsuits for Xiaflex injections there are for personal damage?  The injection caused great harm and damage to my finger….including necrosis.”

The number of lawsuits for Xiaflex procedures is not widely available. This is not by accident.  The medical and drug industries do not make that information public.  Google “how many lawsuits for Xiaflex injections,” and no hard numbers come up.  Perhaps a good attorney might be able to say how many Xiaflex lawsuits have occurred.

However, there is another way to get an idea about the number of lawsuits for Xiaflex injuries.  Simply go to online sources of information about Xiaflex.  Learn what people are saying about what happened to them after a Xiaflex procedure.  Once you learn what happens to people after a Xiaflex procedure, you can assume how likely they might be to take legal action.  Sources:

  • FDA Xiaflex information and comments
  • Drugs.com Xiaflex information
  • WebMD.com Xiaflex information
  • DCI and NHE LLC information from Xiaflex patients

Xiaflex complaints received by the FDA each year    

Year    Total complaints

2012              39
2013  23
2014  40
2015  342
2016  420
2017  320
2018  411
2019  659

Each year the Food and Drug Administration (FDA) reports the number of complaints it receives about many drugs – including Xiaflex.  The chart to the left shows that number of Xiaflex complaints increases each year.  Therefore, the number of lawsuits for Xiaflex treatment is likely increasing, also.  Although not an exact number, a trend is easy to see.

If the FDA determines that the complaints have reached an excessive number, they will investigate.                          

Additional information is available on the FDA website concerning type, location and degree of injury in these Xiaflex complaints.   Compare the FDA Xiaflex complaints to your complaints for an idea how reasonable a Xiaflex lawsuit might be.

Satisfaction rating on Drugs.com.

Visit drugs.com to read patient reports about Xiaflex usage.   Patients give a satisfaction rating for their Xiaflex outcomes.  On a scale of 1-10, with 10 being the highest satisfaction, and 1 being the lowest satisfaction, the majority of people give a low satisfaction rating.  In fact, in May 2020, of nine total people responding, the average satisfaction level was 2.1 out of a possible 10 – shocking.

From this, a person can assume there is a large trend of unhappiness with Xiaflex.  This low level of dissatisfaction could easily cause patients to start a Xiaflex lawsuit.

WebMD.com rating gives low star rating for Xiaflex

WebMD.com allows patients to rate the drugs they take on a 1-5 star scale. These patients also tell stories about their drug usage.  They also rate the effectiveness, ease of use and satisfaction with many drugs.  Anyone thinking about Xiaflex should read the WebMD page about Xiaflex.

On this page, 81 patients who had the Xiaflex procedure provide stories about what happened to them.   As a group, they are not very satisfied after having the Xiaflex procedure.   In May of 2020, the satisfaction level with Xiaflex is 2.42 stars out of a possible 5 stars. This insight should give you an idea how people feel about a Xiaflex lawsuit.

More reports about lawsuits for Xiaflex

Unfortunately, as the use of Xiaflex becomes more common, DCI and Natural Health Education LLC receives more stories like yours.  Typical stories all mention some degree of injury or destruction of finger and hand muscles, joints, nerves, flesh and blood vessels.  Of course, these injuries cause a wide range of mild to severe problems.  For example, loss of hand function, pain, loss of feeling, weakness, limited movement and flesh erosion wounds needing reconstructive surgery by a plastic surgeon.  Many of these people say they already have a Xiaflex lawsuit for their severe injuries.

Although rare, we have heard of two cases leading to amputation as a final solution.  One was a finger amputation. The other, a partial hand amputation.  It is reasonable to assume there is a high percent of lawsuits for Xiaflex injuries in such extreme cases.

Tissue necrosis

Sorry to hear of your bad Xiaflex reaction.  You mentioned that necrosis of your finger occurred.

Necrosis is the unnatural and premature death of some or all cells in an organ or tissue.  Causes include loss of blood supply, freezing, burning, infection, toxins, trauma or digestion by enzymes.  The area affected can be large or small.  Necrosis can result in a wide variety of serious and painful side effects in any tissue close to the site of Xiaflex injections.

Tissue necrosis is a serious complication.  It is perhaps the most common and potentially complicated injury after a Xiaflex procedure goes wrong. This is true because the nature of necrosis is that the tissue dies and does not heal.  Tissue destroyed by necrosis does not come back.

Locate an attorney for a Xiaflex lawsuit

Lawsuits for Xiaflex are never simple or easy. You want someone working for you who has conducted at least several Xiaflex lawsuits.  However, the Xiaflex procedure is relatively new.  For this reason, not many lawyers have much experience in this area.  For helpful ideas to locate a great attorney specifically for this problem, see Xiaflex lawsuit.

Good luck with your hand.

Why is Xiaflex not indicated for palmar nodules?

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Hello,

Why is Xiaflex not indicated for palmar nodules? If it weakens and dissolves the cord, why would it not dissolve a nodule?

Thank you,

RSW

 

Greetings RSW,

The fact is a Xiaflex injection would weaken and dissolve a palm nodule, but then you would have a hole in the palm of your hand.   For this reason Xiaflex is only used to treat Dupuytren cords which are below the surface of the skin.

Of course, with Xiaflex injections the medical profession knows that the Dupuytren cords will return rather quickly, usually just a few years, and more injections would then be used.  There are two problems in doing this:  1. No one knows what happens to the body with repeated Xiaflex injections.  2. Each time a person has a Xiaflex injection as a Dupuytrens treatment he or she runs the risk of having the Xiaflex dissolve normal tissue and cause problems greater than having Dupuytren’s contracture.  For this reason we strongly suggest that anyone with Dupuytrens contracture first attempts to correct their problem using Alternative Medicine.  TRH     

Can I treat Dupuytren’s contracture naturally without surgery or drugs?

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New Dupuytren non-surgical and non-drug treatment

Natural Dupuytren contracture treatment

Anyone who has spoken to his family medical doctor, orthopedist or hand specialist about Dupuytren contracture treatment has been told the only options are some form of hand surgery and Xiaflex drug injections.  But this is not true.

There is another viable Dupuytren treatment option and that is the use of Alternative Medicine to attempt to increase the healing ability of the body.  This is explained that with a better supported healing response the body will have a greater capacity to reduce or eliminate the Dupuytren lumps or cords, as well as reduce the finger contractures that eventually develop.

Avoid hand surgery and drug injections with Alternative Medicine

Dupuytren Contracture Institute has worked since 2002 with those who have had one or more hand operations, and has seen it is possible to eliminate or greatly reduce the need for a second surgery. Many of the people who work with our ideas find their doctors no longer want to do a second surgery after they make significant progress with natural therapies for their Dupuytren hand problem.

For those who never have had a Dupuytren operation, DCI suggests following a conservative treatment  option that consists of a short therapeutic trial of Alternative Medicine remedies first – rather than last – in an effort to possibly avoid hand surgery.  For those who already have had one or more Dupuytren surgeries, DCI suggests it is still possible to follow the conservative option but with reduced expectation.   Either way it makes sense to consider natural Dupuytren treatment as a way to possibly postpone or avoid another hand surgery.

Bulstrod, Loos and Messina are well respected medical researchers who report successful Dupuytren treatment outcomes with exercise, massage and traction, all without surgery. In spite of good clinical results their work is not given much interest because research funding is always directed toward innovative surgery and high profit drugs.   There is almost no financial incentive to research or document the value of the combined use of low cost natural Alternative Medicine treatment for Dupuytren contracture with, minerals, herbs, traction, massage or exercise that a person use at home.

Only a short therapeutic trial of aggressive natural treatment is needed to learn if your body can reduce or even eliminate the palm lumps of Dupuytren contracture.  To learn about the wide variety of natural self-management ideas that DCI has been developing since 2002, visit Different Way of Looking at Dupuytren Contracture Treatment.

Three primary reasons to avoid surgery for Dupuytren contracture

DCI has never suggested anyone not have hand surgery when it is recommended by a treating doctor.  But, DCI always recommends a patient learns the pros and cons of any therapy.  There are three fundamental things about Dupuytren surgery in all its forms or the use of Xiaflex injections that should be of special interest to anyone thinking about using them.

  1. Recurrence of Dupuytren contracture does occur after surgery.  No surgery or drug stops this problem, but delays it.  Eventual return of the nodules, lumps and cords, with gradual flexion contracture of the involved finger, develops again at the rate of 50% of people five years after surgery.  In later years that percent of recurrence continues to rise over time.  It is commonly held that eventually any9one who has had Dupuytren surgery will experience a return of the problem.
  2. Dupuytren surgery removes both normal and abnormal tissue from the hand and forever changes the physical relationship of tissue that remains, therefore after surgery the hand cannot return to a fully normal state and sometimes worsens.  Pain, stiffness, numbness, tissue hypersensitivity, reduced blood flow can all start – or worsen – after the kind of surgery that is done to remove Dupuytren lumps, nodules, cords and joint contracture.  Common and simple activities of daily living (washing, dressing, shopping, typing) can continue to a problem after surgery because normal tissue must be removed along with abnormal tissue of the hand.  Very often people who have had Dupuytren surgery learn they have simply traded one kind of hand problem for another; sometimes the new problem is less than the original one and sometimes it is worse. Anyone who thinks the hand will be like new after having a Dupuytren hand surgery will be disappointed.  The hand is always compromised in some new way that can be large and small, even though the immediate problem of finger contracture is usually improved for a few years after surgery.

In conversation with hundreds of people over the years who have had Dupuytren hand surgery, the two most frequent comments are:  1. “My finger is straighter, but now I have new hand problems.”   2. “I was definitely better for a year or two, and then the hand  problem came back worse than before.  I think I would not have had the first surgery if I knew it would only lead to a second one so soon, and so little genuine improvement.”

No Dupuytren surgery can make the hand as good as new, although everyone I have ever spoken to about their hand surgery has told me this is what they expected as the outcome of their hand surgery.

It is true that needle aponeurotomy (fasciotomy) is less invasive than different types of open hand surgery (fasciectomy), however NA still carries the problem of a much faster recurrence rate and presents the possibility of surgical error since it is done blindly because the surgeon is not able to see the tissue he is slashing with the needle tip.   For this reason, in this type of surgery the skill of the surgeon is extremely important.

  1. With each hand surgery that is done, the next hand surgery will be more complicated and subsequent risks greater because there is less normal tissue remaining in the hand and the increased development of scar tissue. The younger a person is when the first Dupuytren surgery is done, the more likely that person will need a second, then third, hand surgery.  If enough surgeries are performed it could happen that eventually no additional surgery can be done – no matter how painful or useless the hand becomes.  When this point is reached sometimes patients opt for finger amputation.

The Dupuytren Contracture Institute estimates that at least 80 percent of the people experience a moderate to marked degree of improvement of their hand problem within the first two to three months of Alternative Medicine treatment, when they faithfully follow our treatment suggestions for use of an aggressive therapy plan, using the therapy products found within this website.   Substituting bargain brand or questionable products while trying to treat this kind of deep soft tissue problem is not wise, and usually leads to disappointing results.

 

Do Xiaflex injections really have a low Dupuytren recurrence rate?

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What does “recurrence rate for Dupuytren contracture” mean? 

Dupuytren contracture is famous for the fact that in about half of the cases the problem returns about five years after hand surgery. For some people the reappearance is as soon as one year after an invasive operation to remove the cords, nodules and contracted hand tissue.  Many people are disheartened to learn that surgery and Xiaflex injections are not a final answer to their hand problem because of Dupuytren recurrence.

Consider a brief delay of Xiaflex injections to see if natural remedies might help

The Dupuytren Contracture Institute is not against Xiaflex injections or surgery for Dupuytren’s contracture.  Since 2002 our position has always been to recommend surgical intervention in those cases that have not responded to an aggressively applied round of conservative Alternative Medicine therapy.  If a brief therapeutic trial of natural Alternative Medicine treatment has limited results, we then advise to have an evaluation from two doctors who specialize in Dupuytren’s contracture for possible surgical or Xiaflex intervention.

>> Natural Dupuytren Contracture Treatment – FAQs

>> Testimonials from Dupuytren Contracture Institute

However, there are those who approach the management of their Dupuytren contracture in the reverse order:  They first have hand surgery for their Dupuytren’s problem and only after the problem recurs do they consider conservative treatment.

People from around the world report they rushed into having a hand operation, not knowing of the possible side effects and recurrence issues that develop after invading the area of Dupuytren’s disease. It is DCI‘s opinion that it is safe and reasonable to attempt to improve the body’s ability to heal and repair the problem of Dupuytrens contracture by aggressively using several conservative Alternative Medicine treatment measures for a short time.  We strongly suggest that anyone with Dupuytren contracture works with what is known and what is available – even if it is not perfect – before submitting to potentially risky surgery.  If DCI’s conservative concepts do not improve or eliminate the hand lump, Dupuytren’s surgery can always be done later.

How low is the Dupuytren recurrence rate after Xiaflex treatment?

Auxilium Pharmaceutical, manufacturer of Xiaflex collagenase injections, boasts that in a two-year study Xiaflex had a recurrence rate of 19.3 percent, a considerably lower rate of return than those who used surgical procedures to treat their hand problem.

The answer to the question “Is the Xiaflex recurrence rate for Dupuytren low?” is a qualified yes and no.

Yes, Xiaflex or collagenase treatment results in a considerably lower Dupuytren recurrence rate than hand surgery.  However, this does not necessarily mean that the rate of recurrence is actually low; it only means the problem will come back slower than what happens after invasive hand surgery. The reality is that hand surgery has a tremendously high recurrence rate, so a non-surgical therapy option by comparison will look favorable.

Every child learns that pointing to someone who has done something worse than you does not diminish his crime.  When you told your mother that the child next door stole 25 cents from his mother, you were trying to make yourself look pretty good for stealing only 10 cents from her purse.  Your mother was not swayed by the faulty logic of a scared child.  In the final analysis, even though the numbers were different, both children did something wrong.

And along a similar line of thought, 19.3% recurrence is still a high rate for Dupuytren contracture to come back after being subjected to an invasive medical procedure that carries risks, even though there are other treatment methods that have a considerably higher rate of recurrence.

Most surgeons will admit that any type of physical invasion into the palm (like with surgery or injections) seems to accelerate the progression of Dupuytren’s disease.  Patients note that their previously slow progressing hand contracture not only recurred after surgery but worsened at a faster rate.

Perhaps a better question to ask is, “Would you want to undergo an invasive medical procedure like a Xiaflex injection series, knowing that 20 out of 100 people will have to do it again in two years?”  The answer should take into account that more injections might not be as simple and uneventful as receiving the first Xiaflex injection.

Xiaflex has a short history of treatment of Dupuytren contracture

Since Xiaflex was given FDA approval for Dupuytren contracture treatment in early 2010, not enough time has lapsed and not enough patients have used this procedure for the FDA to know sure what will happen to those 19.3% of patients who have recurrence within two years after receiving a second – or third or fourth – injection series.

For example, recent research information released about Xiaflex at the three year follow-up shows that 34.8% of joints with initial clinical success experienced recurrence, considerably higher than the 19.3% recurrence rate reported at the two year mark.  It is reasonable to speculate that the Xiaflex recurrence rate will continue to increase at the four and five year follow up marks, bringing Xiaflex recurrence much closer to the frequency of hand surgery.

There are two valid issues to consider about repeated injections with a new drug like Xiaflex:

  1. When Xiaflex is injected to dissolve the collage cord of Dupuytren’s contracture it carries the risk of physician error and unintended drug consequences, such as injection into a nerve or artery, accidental leakage causing destruction of tendons or muscles, or drug side effects.
  2. No one knows the long term consequences of multiple Xiaflex injections over time into the same area. After all, 70% of people who receive their first Xiaflex injections find that the Dupuytren cord does not break as it should; they must return one month later for another series of injections; if this does not work, they again must return in one month later.  The manufacturer does not recommend that anyone receives more than three series of Xiaflex injections if it did not dissolve the cord by that time.  In this way the manufacturer of Xiaflex is admitting there is a reasonable limit to how often and how much this drug can be used for the same cord.

Return of Dupuytren after hand surgery

There are two common types of Dupuytren hand surgery. The first is palmar fasciectomy (cutting the palm open to remove the deep connective tissue of the palm and collagen cords) with a 35% recurrence rate after two years.  The other is needle aponeurotomy or palmar fasciotomy (inserting a needle into the palm and blindly slashing at the Dupuytren cords wit h the tip of that needle) with an 85% recurrence rate after two years.

By comparison, yes, the Xiaflex return rate of 19.3% recurrence at two years is lower than aggressive surgery. However, this recurrence rate for Xiaflex is said to be low only because the recurrence rates for the other types of surgery are so terribly high by comparison.

At the Dupuytren Contracture Institute we take the position that it is better to avoid the risk the hand problem will return after undergoing any kind of hand surgery by first attempting Alternative Medicine natural Dupuytren treatment.