Transvaginal Mesh: The Types of Surgeries Which Use this Controversial Device

By Independent Staff Writer

As more information comes to light regarding the potential safety issues of the transvaginal mesh implants, women across the nation have more questions regarding the device. The FDA has yet to make a final determination on how mesh devices will be approved in the future and whether the current manufacturers will be subject to more rigorous scrutiny regarding the mesh device. It appears that there are now thousands of women coming forward with stories of adverse events following their transvaginal mesh surgery leading the FDA to require sterner warnings regarding use of the mesh. Physicians are being warned to strongly consider alternative or more traditional surgical methods in repairing pelvic organ prolapse and stress urinary incontinence and women are urged to be fully informed of potential risks before undergoing transvaginal mesh surgery.

Hernia Repair Using Mesh
The mesh used in many surgeries today was originally used strictly for abdominal hernia surgeries and appeared to work well in this application although there were some complications reported. The patch for a hernia repair is typically larger than one used in a transvaginal application so remains in place more securely. Studies show that a Type I mesh tends to be tolerated better, resulting in the fewest complications when used in hernia, POP and SUI surgeries, and infections using this type of mesh are rare. Type I meshes are monofilament and somewhat porous, which allows the body’s bacteria-fighting cells to have unimpeded access to the mesh implant. Mesh made of Gore-tex has been shown to cause the highest rates of infection and erosion therefore is being used less and less often in the transvaginal application.

Necessity for Pelvic Organ Prolapse Surgery
In a woman’s twenties and thirties her natural connective tissues and ligaments will hold her pelvic organs firmly in place.  As women age and undergo pregnancy and childbirth, those connective tissues begin to stretch out of place, allowing the descent of one or more of the pelvic organs including the uterus, vagina, bladder or rectum. The fascia in a healthy pelvic floor is comprised of a natural elastic mesh layer which keeps the organs where they should be. When this fascia begins to break down and weaken, organ prolapse can occur in varying degrees of seriousness. It is estimated that as many as half of all women who have had at least one full term pregnancy have some level of pelvic organ prolapse.

Risk Factors for Pelvic Organ Prolapse
The known risk factors which increase the odds of pelvic organ prolapse consist of the ever-present genetic link, menopause, being older than sixty, previous pelvic surgery or surgeries, number of full-term pregnancies as well as issues associated with increased stomach pressure such as being overweight. Even though fifty percent of women who have gone through childbirth may have some level of POP, most of them do not have symptoms so severe as to require surgery.

For those women who do have symptoms severe enough to affect their overall quality of life, they may need to have some form of surgical treatment to alleviate the pain and other symptoms. It is necessary to fully evaluate each woman’s individual case before deciding on a course of action. The length and severity of the symptoms will of course be a factor as well as the woman’s desire for treatment the degree of the prolapse and whether or not she is healthy enough to undergo surgery.

New Data From Britain About DePuy ASR Acetabular Hip Replacement Devices

By Independent Staff Writer 


Is Johnson & Johnson Telling the Truth About the Failure Rate?
Johnson & Johnson claimed the failure rate was 13% when it recalled the DePuy product in 2010, according to its press release. Johnson & Johnson started using the device in the United States in 2005 and based its failure rate on five years of research.  However, England has a hip registry dating back well before 2005.
This week a report by The British Orthopedic Association revealed the DePuy ASR XL hip replacement unit fails as often as 49% of the time. This is an astounding four times what Johnson & Johnson reported stated when it recalled the device last year.

Dr. David Beverland, an Irish orthopedic surgeon who does massive numbers of hip and knee replacements reported that he started implanting the ASR devices in his patients in September 2004 and stopped in May 2007. He declined to say why he stopped the implants, but reported that 32% of his ASR XL patients have been or will need a second hip replacement (revision) and 44% are symptomatic. Only about 22% of his ASR XL patients seem to have achieved a good result and three of his patients died after receiving the implant. This is a serious problem for the defense since Beverland has been a major consultant and product champion for DePuy.
Here are the real facts:

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 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?

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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?