Recalls on Transvaginal Mesh Implants

Transvaginal Mesh Recalls

Vaginal mesh withdrawals, corrections and lawsuits - what you can do

As of February 2016, there are no vaginal mesh recalls by the Food and Drug Administration, despite the severe health issues coming to light through thousands of vaginal mesh lawsuits. The FDA has, however, issued public safety notifications and reclassified the vaginal mesh devices as Class 3, which is the highest-risk category. Why have they not taken a firmer stance? Why have manufacturers been the ones to remove products from the market? Learn more and see how to hire an attorney for your transvaginal mesh lawsuit.

Transvaginal mesh recalls are uncommon and always cause for concern.

The FDA (abbreviated from U.S. Food & Drug Administration) is a branch of the federal government that oversees regulation and safety concerns for prescription medications, medical devices, over-the-counter drugs, cosmetics and particular food items. Many individuals have been implanted with devices that were later recalled; some had no problems at all, while others required revision surgery to rectify the problem. (Learn more on how the FDA recalls medical devices.)

Enjuris tip: More than 100,000 women are suing surgically implanted gynecological mesh manufacturers like Boston Scientific in what is believed to be the largest multi-district litigation since asbestos. CBS News recently covered the story in a 60 Minutes special. See the interview with leading plastic expert Duane Priddy on the use of polypropylene in the human body.

Where does the FDA stand on vaginal mesh recalls?

The FDA places medical devices in one of three regulatory classes. The device must meet the FDA regulations for that class.

At first, transvaginal mesh was a Class 2 medical device, meaning that if it was "exempt," it did not need to go through premarket approval with the FDA to determine safety and efficacy.

However, in January 2016, the FDA strengthened its position in regard to this product. They issued a public safety announcement that had two final orders:

1) Transvaginal mesh would be reclassified to Class 3, which is the most stringent of all labels and is for medical devices that pose a high risk to health and safety; and

2) The products would need premarket approval prior to mass distribution.

The FDA took a while to get to this point. They issued public safety notifications in 2008 and 2011, but there were still significant numbers of patients experiencing post-surgical problems with their vaginal mesh. As such, they convened an advisory panel in 2011 and issued an order in 2012 that would make manufacturers conduct postmarket surveillance on their products.

Many manufacturers did whatever they could to avoid conducting this postmarket surveillance, including changing labeling, pulling it from the market or even claiming that the device was not, in fact, transvaginal mesh.

Enjuris tip: Just because your specific implant is the subject of a voluntary recall (or even an FDA recall) doesn't mean it must be removed.

In reclassifying transvaginal mesh as Class 3, the FDA has made its position clear. Transvaginal mesh is a product that poses significant health concerns.

However, they will not do more without additional research.

As Dr. William Maisel, deputy director of science and chief scientist for the FDA's Center for Devices and Radiological Health, says, "These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse. We intend to continue monitoring how women with the device are faring months and years after surgery through continued postmarket surveillance measures."

Has the FDA ever recalled a transvaginal mesh device?

Technically, the FDA has never recalled a transvaginal mesh device.

There have been plenty of voluntary withdrawals on the part of manufacturers, and there have been market corrections. However, the federal government never took it upon themselves to recall a device. Below you can see what they did do.

Date FDA Action on Transvaginal Mesh Implants & Devices

January 6, 2017

Surgical tools are reclassified to Class 2, which means that device manufacturers must provide premarket notification to the FDA before selling the instruments.

February 26, 2016

The FDA convenes a panel to discuss the reclassification of surgical tools used in mesh surgeries.

January 5, 2016

Transvaginal mesh devices are placed in Class 3 and now require premarket approval.

May 1, 2014

The FDA proposed changing the device from Class 2 to Class 3, along with reclassifying the accompanying surgical tools from Class 1 to Class 2.

July 13, 2011

The FDA issued an update to their 2008 notification. This stated that "complications associated with transvaginal repair of POP are not rare." They also said that these implants are a greater risk for POP patients than non-mesh surgeries. They could not even say whether mesh surgeries were more effective.

October 20, 2008

The FDA issues a Public Health Notification to doctors regarding the potential risks of transvaginal mesh when used in pelvic surgeries. In two years, they received more than 1,000 reports of complication in POP and SUI patients.

Just because other people have had transvaginal mesh lawsuits and issues does not necessarily mean that you will, too. You should be concerned when your doctor informs you of a recall based on what he or she has learned from the FDA, and that the device must be removed immediately. Otherwise, wait until you start experiencing physical symptoms (if you ever do).

As noted, the FDA has only said that transvaginal mesh can cause serious health complications and that these complications are "not rare." However, they have not issued any recalls. Their stance is that, with enough clinical data from postmarket surveillance, they will be able to adjust existing products so that they are safer and more effective.

There have been plenty of voluntary recalls or product withdrawals by device manufacturers, though, most likely because of the numerous vaginal mesh lawsuits.

List of voluntary transvaginal mesh recalls/withdrawals

Vaginal Mesh Manufacturer Mesh Products Recalled What Happened

Boston Scientific

ProteGen Sling

This is the big one, the mother of them all - the mesh monster from which all other mesh monsters were spawned. This product was cleared for sale in 1996 for stress urinary incontinence (SUI) surgeries.

It only took months before patients began reporting serious post-surgical complications. The product was voluntarily recalled in 1999, only three years after it was introduced.

The ProteGen Sling was the model for a number of similar products, and because there was a "substantially similar" product already on the market, they were approved without premarket testing. That led to hundreds of thousands of additional lawsuits against various companies, many of which still have products available.

Mentor

ObTape vaginal sling

Discontinued in 2007, though they did not pull devices that were still available on the market. They continued to be used in pelvic surgeries.

C.R. Bard

Avaulta Plus, Pelvilace, Uretex

Withdrew a few of their products after there were calls for more clinical testing.

Ethicon

Gynecare Prolift Kit, Gynecare Prolift + M Kit, Gynecare TVT Secur, Gynecare Prosima , Pelvic Floor Repair System Kit

This division of Johnson & Johnson took 4 of its Gynecare products off the market, though they claimed it was not because of safety concerns.

They actually still sell some Gynecare devices, though they changed the labels so they are indicated for transabdominal insertion, not transvaginal.

The Gynecare TVT Secur was only tested on sheep and 31 human women for five weeks before mass distribution.

Endo and subsidiary American Medical System (AMS)

Apogee Vaginal Vault Prolapse Repair System, Perigee Transobturator Anterior Prolapse Repair System, Elevate

This medical device manufacturer closed their Astora Women's Health division in 2016, which made their transvaginal mesh products. This was because the company had to devote billions of dollars to transvaginal mesh lawsuits. It also sold its subsidiary AMS, which produced transvaginal mesh products that were the subject of 22,000+ lawsuits, to Boston Scientific.

What does this mean for patients, especially those who already have a transvaginal mesh implant inside them?

Keep in mind that just because you have an implant that has been recalled does not mean it must be removed, even if the FDA or a manufacturer says there have been problems with that product. Those problems could be as small as a misprinted label or as large as the device breaking down.

Transvaginal mesh lawsuits

There are a number of active lawsuit cases that women can join if they have suffered complications from transvaginal mesh implants, whether or not the implant is listed among the transvaginal mesh recalls.

Approximately 100,000 vaginal mesh lawsuits are pending before Judge Joseph Goodwin in West Virginia, though many have settled, gone to trial or have been dismissed.

The form of these cases looks like a class-action lawsuit, but they are actually called "multidistrict litigation," or MDLs.

There are a few key differences between the types of cases, such as MDLs only being consolidated for pretrial proceedings and discovery before being returned to the court in which it was originally filed. Then, your case can be viewed with the evidence and rulings provided by the MDL judge and completed in your original jurisdiction where you first filed.

There are thousands of pending lawsuits for transvaginal mesh – can you join one?
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MDLs are only filed in federal court. The Judicial Panel on Multidistrict Litigation, or the JPML (seven federal judges who oversee all MDLs), can decide whether to bunch your individual case with hundreds or even thousands of similar cases that share a common question of fact.

This means you will hopefully avoid the duplicative presentation of evidence and streamline your case in the court system, since there are so many cases like yours. The JPML's idea is, why present the same case thousands of times if you only need to do it once?

As of November 2017, more than 40,200 individual vaginal mesh lawsuits were still pending. The following are active MDLs for vaginal mesh lawsuits (an "action" or "claim" is another name for an individual lawsuit).

Number of Vaginal Mesh Lawsuits

Defendant Pending Total

American Medical Systems

1,264 pending lawsuits

21,180 total lawsuits

Boston Scientific

8,603 pending lawsuits

24,334 total lawsuits

Coloplast

145 pending lawsuits

2,620 total lawsuits

Cook Medical

186 pending lawsuits

635 total lawsuits

C.R. Bard

3,621 pending lawsuits

15,568 total lawsuits

Ethicon

26,393 pending lawsuits

39,442 total lawsuits

ObTape

A total of 867 lawsuits were filed in this action between 2008 and 2017, though the judge asked the JPML to stop adding cases.

He stated that too many cases did not have enough evidence or that they were barred by the statute of limitations (the filing window). However, the MDL has not been closed, and six cases are pending. Women can also choose to file claims against ObTape in state court.


How to start or join a transvaginal mesh lawsuit

If you think you have a case against a transvaginal mesh manufacturer, it is important to consider the following:

Do I need a lawyer?

Yes, yes, and yes. Products liability lawsuits (also known as defective products) require expert testimony, lots of depositions and mountains of evidence. The manufacturer, meanwhile, has gobs of money at its disposal, with which they can throw up any number of roadblocks. An attorney with experience in this area knows how to play the game.

How can I join a vaginal mesh lawsuit?

There are two ways: either your lawyer files a motion to transfer your case into an existing MDL, which would save money on pretrial aspects of the case; or the JPML can order you to transfer into an MDL if there are common questions of fact.

What does joining a lawsuit really mean?

Put bluntly, you will be talking about your vagina to anyone who asks about it. It will likely take a few years to finish the case, and before then you will be deposed (put under oath and asked questions by opposing counsel about your health complications). If the case goes to trial, you might have to testify. Joining a lawsuit means having endless patience and understanding that you might have to discuss your private problems in open court. At the very least you will undergo independent medical examinations, which are doctors' appointments with a medical professional chosen by the defendant.

Do I have to pay to join a case?

If any lawyer asks for a retainer for a personal injury case, RUN. Lawyers should take a third of the proceeds, plus costs (filing, copying, etc.). That can increase if you go to trial (a normal number is 40% in that instance).

What can I expect to receive as compensation?

All legal fee agreements generally have a line that says "Past performance does not indicate future rewards." This means that even a rainmaker can't promise you anything. All an attorney can do is provide a range, telling you which clients got A and how many got B. Some cases go to trial and a jury awards damages; others settle prior to a verdict. Those settlements have reached $20 million for a single plaintiff, like the one against Ethicon. However, other plaintiffs have had their cases tossed out for lack of evidence. All of this means that nobody can predict anything and those who do are lying.

How will joining a lawsuit impact my doctor?

While you might feel that filing a case is a betrayal to your doctor, at the end of the day you have to take care of yourself. You need to do what's right for your body, and a good surgeon will support you in that decision (since really, it wasn't his fault; it's the device itself). The surgeon will almost certainly be called as a witness. If he is experienced, he will have played the game before.

How to hire a transvaginal mesh lawyer

If you are experiencing pain at your implant site or you hear that your implant was the subject of a transvaginal mesh recall, the first thing you do should be to speak with your surgeon. It is most important to address any immediate problems before going further.

Enjuris tip: If your surgeon says you are a candidate for mesh surgery, ask 1) how many times they've done the surgery, 2) how many patients had complications, 3) whether they have successfully removed mesh, and if so, 4) how many times?

Once you are physically under control, then get a lawyer. Many women feel more comfortable with a female attorney, as these cases involve intimate areas.

You can also start with a Google search along the lines of "Florida defective products vaginal mesh attorney," where you substitute Florida for your state. You can also get a specific as your city, such as "Tampa products liability vaginal mesh lawyer." This will help to narrow down your results, since just Googling "mesh implant attorney" will result in too many results to parse through.

How do you know if an attorney is up to snuff? Read online reviews to pick the best lawyers. Then, once you have about five options, speak with them in person. You can interview each one and decide if he or she is equipped for your needs. Only by talking in person will you be able to determine the best of the bunch.

Personal Injury Attorney Interview Sheet
Worksheet with questions to ask a personal injury attorney to help determine if he or she will be a good fit for your case
Download in PDF format

Also, remember that each state has a statute of limitations (the time window in which you can file your case). Once that time has passed, you are barred from filing. A few states only offer one year for cases, so if you have to, get any attorney to file your paperwork and then choose a new lawyer for the more complicated aspects of the case.

Products liability law is specialized and difficult. You need a lawyer who has years of experience and knows how to work with pending multidistrict litigation cases. If you have not met with an attorney yet, try the Enjuris directory for someone in your state who can hold your hand along the way.

More on Transvaginal Mesh Lawsuits

Next article: Stress urinary incontinence and vaginal mesh lawsuits

Return to the main vaginal mesh lawsuits guide

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