Transvaginal Mesh Discussions Part 1: Medical Conditions Which Precipitate the Use of Transvaginal Mesh

By Independent Staff Writer

Pelvic Organ Prolapse (POP):
Pelvic organ prolapse happens when an organ in the pelvic area drops or prolapses from its normal position and pushes against the walls of the vagina or other organs. Especially in cases where the muscles which hold the pelvic organs in place become weak or stretched from childbirth or surgery, pelvic organ prolapse can occur.  The vagina and uterus are held in place by ligaments, however when the pelvic floor muscles grow weaker the ligaments relax, allowing the vagina to move toward the vaginal opening. 

The bladder and rectum are in close proximity to the vagina, so a prolapse can lead to a loss of bladder or bowel control, difficulty urinating or very frequent urination, a feeling in the vaginal region as though something has dropped, chronic bladder infections, moderate to severe pain during sexual intercourse and chronic pain in the back area. As many as one-third of all women in the United States will undergo some type of treatment for pelvic organ prolapse by the age of sixty, and by the age of eighty at least one out of ten women will have undergone surgery for the prolapse. Pelvic organ prolapse can severely limit a woman’s daily life, yet many women are embarrassed to speak to their doctors about their symptoms.

What Leads to POP?
Age is the primary factor in pelvic organ prolapse; menopause brings about loss of estrogen which in turn leads to loss of muscle tone. Women who have undergone multiple vaginal deliveries or who have a family history of pelvic organ prolapse are more likely to develop the condition as are those who have suffered some sort of pelvic trauma or prior pelvic surgery. Childbirth in particular causes the muscles, fascia and ligaments to separate and weaken as the baby passes through the birth canal and in later years may result in a drop of the pelvic organs from their normal position. Repeated heavy lifting can lead to pelvic organ prolapse as can being significantly overweight.

Becoming part of a mass action lawsuit over the DePuy hip implant gives you an edge that going solo can't afford.

By Independent Staff Writer

Many different law firms are suing DePuy Orthopaedics over the faulty ASR XL Acetabular System. In a personal, vulnerable situation like this hip implant case, it can be difficult to assess the situation and make the right legal decision for you. In this article, we'd like to break down the difference between mass action, class action, and solo cases so you can make a well-informed choice for yourself.

"One Riot, One Ranger"

When a single person with a single lawyer brings a case against one organization, our firm's Andrew Sullo likes to call it a "one riot, one ranger" case: one person was harmed, and one person needs to set it right.

Let's take a hypothetical. Company X has a trucking business. One of its drivers runs into a pedestrian and causes serious injury. The driver was clearly negligent and the pedestrian was clearly hurt. The damages amount to $1 million. If the lawyer presents a good case, it's likely that the case will be settled for the $1 million, and Company X won't bother spending much on its own legal defense.

Company X could, of course, spend $1 million to avoid paying the $1 million to the plaintiff, but this would take up time, company resources, and would likely land them some bad press. If the money will be spent anyway, it's in Company X's best interest to simply pay the plaintiff with it instead of using up those resources.

"One riot, one ranger" is a very effective way to settle a case with a single client who has a single complaint, because it simply isn't worth the legal fees to Company X to defend the case when it can be settled for its fair value. They would rather settle the case, reluctantly compensate the plaintiff for his injury, and move on.

So if "one riot, one ranger" cases are effective, why isn't that the best way to bring a case against DePuy for their faulty hip implant?

If a single person had received a single faulty hip from DePuy, it would be a great way to bring the case. Unfortunately, we're dealing with 93,000 people who received recalled hip implants, many of whom will now have medical consequences.

And in that situation, the math starts to work against the plaintiffs.

Bluffing Without a Hand

Going back to Company X for a moment, let's say that instead of the truck running into a single pedestrian, the truck ran into a plane full of people. 200 people are seriously injured. Each of those 200 people runs out and gets a lawyer. The cost of the injuries is far beyond our original case scenario - perhaps a few people have injuries totaling $1 million worth of compensation, but others will have lower or higher damages.

Instead of paying a one-time settlement of $1 million, Company X is now looking at paying several hundred million, because there are so many people to settle with.

Suddenly, shelling out a couple million in lawyer's fees to defend against the lawsuits is a much better deal for Company X.

Each individual lawyer (assuming they are working on a contingent fee basis) will have to put up his or her own money to fight the case. Company X can afford to put a lot more money into the case than the lawyers can because they are ultimately saving themselves from the even more expensive consequences of settlement.

One plaintiff might have a $10,000 case, and the plaintiff's lawyer might be willing to put in up to that amount of his own money to see justice served. But Company X can afford to put in millions - even if the case isn't actually worth that amount - just so they won't have to settle with the other 200 individual cases as well.

In a case where there are many people who have been harmed, it's a case of "divide and conquer." The more lawyers who are depending only on their own funds to bring a case against Company X, the more power and leverage Company X has. They know the lawyer can only afford to put in a certain low amount of money, so when the bargaining starts, the lawyer is bluffing with a bad hand. Company X knows it can outbid him. The lawyer knows Company X can outbid him. He's got nothing to bargain with.

Enter the mass action lawsuit.

The DePuy ASR XL Acetabular hip replacement system was FDA approved - which might be more cause for worry than relief.

By Lacy Boggs

Since 1976, all medical devices must be classified and approved by the U.S. Food and Drug Administration (FDA) before they can be legally marketed to the public. It is the fond belief of many Americans that FDA approval is a ringing endorsement of a product's safety, a guarantee that the device has been tested and re-tested by professionals who are presumably trained to put the device through all kinds of rigor to triple-check its safety and effectiveness before allowing it anywhere near our fragile human bodies.

It is, as we say, a fond belief, but not an accurate one. It seems that many medical devices - including the recently recalled DePuy ASR XL Acetabular System - are given an FDA approval and subsequently placed inside people's bodies without ever going through a single test at the FDA. 

The FDA department responsible for the regulation and review of medical devices is the Center for Devices and Radiological Health (CDRH). CDRH divides medical devices into three classes: life-sustaining, life-supporting or implantable devices are designated as Class III.

Hip replacements, including the ASR XL system, qualify as a Class III device and are considered high risk to the patient's health. 

Class III devices can be approved by the FDA through one of two processes. The first, the premarket approval process (PMA) is more or less what we think of when we imagine our device being tested by the FDA: an extensive review including rigorous clinical trials that show it to be safe for use in humans. The PMA is quite detailed, lengthy, and expensive, usually costing the manufacturing company upwards of $250,000 and taking as much as two years to complete.

A quarter of a million is a large chunk of change - but thankfully for companies with a firm eye on their bottom line, there's always the second FDA approval process.

The premarket notification approval process, also known as the 510(k) approval process, is a sort of shortcut to approval that lowers the price point considerably - and also, conveniently, doesn't involve any pesky testing that might reveal a flaw in the product that would then have to be revamped and retested for another quarter-million. 

The 510(k) process basically pre-approves any product that is deemed "substantially equivalent" to another product already legally approved for sale. It costs less than $5,000, requires no clinical trials, and only takes an average of 3-6 months to complete. It's a good shortcut for products that are essentially identical to their forebears. After all, it hardly makes sense to waste the FDA's time when they could be helping get new, innovative, life-saving products to market. But what's to stop companies from claiming their products are "substantially equivalent" to other FDA-approved devices even if they're not remotely the same?

What, indeed 

The ASR XL Acetabular hip replacement system got its seal of approval from the FDA using the 510(k) process, claiming that its product was substantially equivalent to other hip replacement devices already on the market. The FDA official in charge of approving the device would have gone through a checklist that included the following questions (simplified; the actual document is fairly dense):

• Does the new product treat or solve the same problems as previously approved products?
• Does the new product have the same design, materials, and energy sources as previously approved products?
• Could any new characteristics or combinations of characteristics affect safety or effectiveness?

The first question is easy: there are dozens of hip replacement devices on the market, all designed to help people walk even after their bum hip throws them out of commission. The second question gives us a bit of a hiccup: the ASR XL Acetabular hip replacement system had two parts, a ball and socket

The ball was equivalent to an approved product; the socket was equivalent to an entirely different approved product; and the materials were equivalent to still a third approved product.

Thankfully for DePuy, the FDA had thoughtfully included a caveat that allowed for such an eventuality. Which brings us to question three: could any new characteristics affect safety?

In DePuy's 501(k) application, it declared that the "subject device does not raise any new issues of safety or effectiveness." A brave statement, though one wonders how the company confirmed such a diagnosis without going through any clinical trials. Perhaps if it had, the problem of metallosis would have become evident before the hips were implanted into approximately 93,000 people.   

With such prerequisites for FDA approval, it is perhaps not surprising that only 10% of 510(k) applications are referred back for supporting human, clinical or animal testing. 

Which is to say that 90% of claims require no clinical testing whatsoever before being sold to patients.

That's not to say that there is no testing at all. If a mechanical test is available, 510(k) approval process requires that the new product show that it yields similar results to a previously approved product. The DuPuy ASR hip replacement system took a few spins on a robot that went through simulated movements. In a legal suit brought against DePuy for a different hip implant last year, the mechanical test did not include the full range of motion of which a human being is capable.            Read more ....

The U.S. Food and Drug Administration’s Letter to Hip Makers Mean

What Does the U.S. Food and Drug Administration’s Letter to Hip Makers Mean?

Home |Personal Injury |DePuy Hip Recall |Traffic Tickets |Family Law |Criminal Defense |Get Informed

The U.S. FDA ordered 21 manufacturers to collect information from patients.

The U.S. FDA ordered 21 manufacturers to collect information from patients in a recent letter to hip manufacturers. Click here for report. The three-page letter demands blood tests and other studies within thirty days. Here is a summary of the information and questions the FDA is requiring from manufacturers:

• The harmful events observed in patients with Metal-on-Metal (MoM) total hip replacement (THR) systems.
• The levels of serum and chromium in patients prior to THR.
• The patient population's average levels of chromium and serum in the blood for a minimum of eight years after the implant (patient population is the demographics and other particulars of a particular population).
• Do the average levels of chromium and serum in the blood increase during the first eight years (or the length of time on the market)?
• Reasons for revision (alteration of a medical device) and patient population's average levels of chromium and serum in the blood at the time of the revision.
• The number of patients with pain and biological and psychological symptoms associated with the THR.
• The quantity of harmful reaction of body tissues in patients who did not have a revision.
• How differences in revisions vary over time after the initial implant?
• What demographics have higher metal ion concentrations in their blood?
• What demographics have higher risks of needing revisions?
• What causes the THRs to fail?