Transvaginal Mesh

CA & WA Attorneys General Sue J&J

By | Transvaginal Mesh, Uncategorized

transvaginal mesh lawsuitThe Attorney General of California and Washington state filed separate transvaginal mesh lawsuits targeting Ethicon and Johnson & Johnson (J&J). Their lawsuits claim that the pharmaceutical giant knew of the serious risks associated with their vaginal mesh products, but the company hid this knowledge. By doing so, Ethicon and J&J violated consumer safety, according to the lawsuits.

Lawsuits Pending in Federal Court

These lawsuits come as thousands of similar cases remain pending in a federal court in West Virginia. Ethicon and J&J are defendants in a multidistrict litigation (MDL) in the US District Court for the Southern District of West Virginia. The MDL is In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL no. 2327.

As of late June 2016, there are over 32,000 transvaginal mesh lawsuits pending in the Ethicon MDL.

J&J Responds to Lawsuits

J&J reacted to the actions of these two Attorneys General by issuing a statement emphasizing that neither they nor their subsidiary, Ethicon, committed any wrongdoing in developing, manufacturing, and marketing their pelvic slings.

The company plans to defend itself against these claims.

Do you have a pelvic sling case?

You can discuss your case with one of our experienced attorneys. We offer free, no obligation case evaluations. Call 800.721.2519, or complete our confidential online form.

Women in Scotland Continue to Receive Transvaginal Mesh

By | Transvaginal Mesh, Uncategorized

Transvaginal mesh surgeryIn Scotland, women on waiting lists and involved in a medical study continue to receive transvaginal mesh implants.

A Scottish news outlet, The Southern Reporter, investigated transvaginal mesh procedures at a hospital near Melrose, Scotland. Reporters discovered that Borders General Hospital (BGH) continued to perform transvaginal mesh surgeries for patients on waiting lists or in a medical study.

Negative outcomes of surgery

The Scottish news outlet reviewed the 2013 operations, and discovered a high percentage of negative outcomes.

In 2013, Borders General Hospital performed 113 operations. Of those…

  • 3% of patients had their vaginal mesh implant fail
  • 8% of patients had trouble urinating
  • 10% experienced mesh exposure
  • 5% suffered severe leg and/or groin pain
  • 2% contracted a urinary tract infection (UTI)

Borders General Hospital told The Southern Reporter that women who opt into mesh procedures now receive up-to-date information about known risks. And because the hospital limits procedures to certain patients and now supplies adequate warning, the hospital argued that it is in compliance.

Vaginal mesh procedures declining

Though the Scottish hospital continues to perform mesh procedures, they are decreasing over time.

The Southern Reporter found that in 2011, the hospital performed 151 operations. In 2014, the hospital performed only 16 operations.

A call to stop vaginal mesh surgery

In 2014, the former Scottish health secretary, Alex Neil, requested that healthcare providers stop performing mesh procedures to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP).

Scottish government publishes report

In October 2015, the Scottish government published an interim report on transvaginal mesh surgeries. The report stated that healthcare providers must receive the most current information on vaginal mesh complications, so that they are equipped to advise patients.

The interim report also noted that vaginal mesh complications can be so severe that they can permanently impact a woman’s life.

You aren’t alone in your suffering

We’re here to help you hold your mesh manufacturer accountable for distributing a defective and dangerous product.


Call us at 800.721.2519, and we’ll review your case with you during a free lawyer consultation.

You can also reach us online by completing a confidential personal injury claim form.

FDA Announces Transvaginal Mesh Now Class III High-Risk Device

By | Transvaginal Mesh, Uncategorized

US Food and Drug Administration logoOn January 4, 2016, the US Food and Drug Administration (FDA) announced a big change for transvaginal mesh. Previously classified as a Class II medical device, the FDA reclassified transvaginal mesh as a Class III device.

This means that the regulatory agency considers mesh to be high-risk.

30 months to reapply for FDA approval

And the FDA didn’t stop there.

They called on all vaginal mesh manufacturers with devices already on the market to reapply for approval.

The FDA gave manufacturers 30 months to submit their premarket approval (PMA) applications.

In these applications, manufacturers must prove that their products are safe for patients, and effectively treat pelvic organ prolapse (POP).

Smooth sailing is a thing of the past

The FDA is tightening the reins on new products, too. In the past, many transvaginal mesh devices received approval via the FDA’s 510(k) process.

Through this process, manufacturer’s only needed to link a new product to an older product that had already won FDA approval; drawing a similarity was, in some ways, the only requirement to get a mesh device onto the market.

For POP only

It’s important to note that the Class III, high-risk ranking applies only to vaginal mesh devices used to treat pelvic organ prolapse (POP). It doesn’t apply to those devices used for hernia repair or to treat stress urinary incontinence (SUI).

Ask your doctor, know all of the risks

Consult with your doctor about all of the options available to treat POP, including those that don’t involve surgery.


If you’ve received a vaginal mesh implant to treat POP, and you’ve experienced injuries, either physical and/or financial, we encourage you to begin exploring your legal options.

Need a lawyer?

Carey Danis & Lowe can help you. Contact us today about our free case evaluations.

Call us at 800.721.2519. You can also reach us online by completing a confidential personal injury claim form.

Boston Scientific Delays, Vaginal Mesh Lawsuits Return to State Courts

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

boston_scientifi_transvaginal_mesh_lawsuitIn late October 2015, a federal judge denied a request made by Boston Scientific, a manufacturer of vaginal mesh devices. The company sought to move 62 transvaginal mesh lawsuits, which were filed as a single multi-plaintiff suit, into a multidistrict litigation (MDL).

An MDL concerning transvaginal mesh injuries and Boston Scientific mesh products exists in a West Virginia federal court. The MDL is In re: Boston Scientific Corp., Pelvic Repair System Products Liability Litigation, MDL No. 2326, managed by Judge Joseph R. Goodwin in the U.S. District Court for the Southern District of West Virginia in Charleston.

The federal judge who denied Boston Scientific’s request stated that the company waited too long to move the lawsuits from state to federal court. In California, U.S. District Judge Beverly Reid O’Connell said that Boston Scientific should’ve issued their request within a year of the lawsuit’s original file date.

Since they waited too long, a state court judge has since separated the individual mesh lawsuits, and sent them back to courts in their state of origin.

This is an unfortunate turn of events for these plaintiffs. Consolidation into the MDL would bring them all one step closer to putting this difficult chapter in their lives behind them.

You don’t have to suffer alone.

We are here to help you. If you or a loved one suffered from a transvaginal mesh injury, we encourage you to explore your legal options.

Carey Danis & Lowe offers free case evaluations, during which we can discuss your compensation eligibility, and whether filing a vaginal mesh lawsuit is right for you.

Call Carey Danis & Lowe today ― 800.721.2519.

You can also reach us online by completing a confidential personal injury claim form.


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Boston Scientific Mesh Damages Cut from $100 Million to $10 Million

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

Boston Scientific Ordered to Release Defective Transvaginal Mesh DocumentsBoston Scientific Ordered to Release Defective Transvaginal Mesh DocumentsA judge in the ongoing mesh litigation against Boston Scientific significantly reduced the amount awarded to a victim in a May jury trial.

New Castle County, Delaware Judge Mary Johnston said the compensations awarded to Deborah Barba ($100 million) – the biggest ever in a trial involving transvaginal mesh – were “grossly disproportionate to the injuries.” Other transvaginal mesh trials have awarded between 1.75 million to 7.76 million in damages.

While the lawyers see this compensation reduction as a disappointment, they’re encouraged that the judge didn’t question the jury’s finding on Boston Scientific’s liability. Judge Johnston denied Boston Scientific’s attempt to set aside the verdict completely and order a new trial.

The mesh devices caused Deborah Barba severe complications, including bladder infections and pelvic pain. The jury found that the device manufacturer had been negligent in designing the transvaginal mesh and didn’t warn doctors and patients about the risks.

Boston Scientific, along with other mesh makers have faced about 100,000 lawsuits at the state and federal level for transvaginal mesh complications.

Carey Danis and Lowe can help victims of transvaginal mesh complications.

If you or women you know have been harmed by mesh devices, call our medical product liability lawyers for a free consultation at 800-721-2519. Alternatively, send us an email.

Our team of medical professionals will answer your questions with compassion and confidentiality. Our attorneys can help you get the justice you deserve.

Vaginal Mesh Surgery: Study on Low- & High-Volume Surgeons

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

vaginal_mesh_lawsuit_litigationSurgical operations strike fear in some patients; before the procedure, they worry about what could go wrong.

A new study shows that less can go wrong with surgeons who’ve performed the same procedure, in this case, transvaginal mesh implants, a large amount of times.

The team of defective medical device lawyers at Carey Danis & Lowe reported on this study in late October 2015. Check out our blog to read that article, and get more background on this study.

Accompanying the study, which JAMA Surgery published in September 2015, was commentary from Quoc-Dien Trinh, a medical doctor specializing in urology at Brigham and Women’s Hospital in Boston.

Trinh commented that when patients select a surgeon, the number of procedures performed by a surgeon is a somewhat reliable measurement in determining the operation’s outcome.

High-volume surgeons made fewer mistakes, according to study data. In fact, the study’s lead researcher remarked that “surgeons who performed a lower number of implants had a 37 per cent increased likelihood of a patient having complications, compared to their higher-volume counterparts.”

Even so, from our conversations with women who have been injured by transvaginal mesh, it’s clear that there’s more to these operations than volume. These medical devices are defective from the start. So, irregardless of volume, surgeons go into these procedures with a defective product.

Do you have a transvaginal mesh case?

If you’ve been injured by transvaginal mesh, you may be eligible to receive compensation for your losses. We offer free, no obligation case evaluations.


We’re here to listen to your experience with transvaginal mesh. Call Carey Danis & Lowe at 800.721.2519, or complete a confidential personal injury claim form.


Scotland’s Health Minister Apologizes to Transvaginal Mesh Victims

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

Boston Scientific Ordered to Release Defective Transvaginal Mesh DocumentsBoston Scientific Ordered to Release Defective Transvaginal Mesh DocumentsShona Robison, Scotland’s Health Minister, formally apologized to women who suffered complications following transvaginal mesh implant surgeries.

Ms. Robison recognized that the medical establishment hadn’t listened to the women who experienced pain and suffering from the implant. The mesh was used to treat incontinence or organ prolapse. She agreed with victims that it shouldn’t have taken an act of Scottish Parliament to expose the issue.

Last summer Health Secretary Alex Neil requested a suspension of the controversial procedure, due to the concerns of women who had suffered from the mesh implant. Many victims were upset that over 75 women have received the operation since the suspension was requested. Fortunately, the numbers of implant surgeries in Scotland have decreased dramatically.

Two members of Scottish Mesh Survivors, Elaine Holmes and Olive McIlroy are asking for an inquiry or independent study to understand the depth of the problem.

An Independent Review of Transvaginal Mesh Implants completed an Interim Report, which called for better training to make sure that medical practitioners were aware of the potential issues after mesh procedures. Another finding was that because women were not believed about their complications, they experienced more distress and had to wait longer for help.

Carey Danis & Lowe fights for victim rights.

If you or someone you love has suffered pain or complications from mesh implants, please call us at 800.721.2519. Carey Danis & Lowe attorneys have the experience and knowledge to provide successful legal representation in medical liability cases.

Our team of professional doctors and nurses will answer your health questions. For a free legal consultation, complete a confidential personal injury claim form.

$2M Vaginal Mesh Verdict Tied Up in Appeals Court

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

transvaginalmeshlawsuitFast-tracking medical device approvals is tying up a $2 million jury verdict. The plaintiff in a transvaginal mesh lawsuit won a $2 million award, but now the award is under question in an appeals court.


The defendant in the case, transvaginal mesh manufacturer C.R. Bard, argues that the verdict needs to be voided. The company contends that evidence presented to the jury was incomplete.

During the trial, both parties didn’t mention how the transvaginal mesh device under question received its approval from the US Food and Drug Administration (FDA).

With most transvaginal mesh products, companies received approval via the 510(k) process.

What’s a 510(k)?

Think of the 510(k) as a template system. A medical device manufacturer submits their transvaginal mesh device to the FDA for approval. That device wins approval due to its rigorous testing, and it becomes the template for future products.

Future transvaginal mesh devices can apply for FDA approval using the 510(k) process, and can cite similarity to that first device that received FDA approval.

In the case of transvaginal mesh, citing similarity was enough to bring these defective products to consumers.

Too many modifications

However, there comes a point when medical devices have been modified so much, they can no longer be considered similar to the first device with FDA approval. This alone should require the manufacturer of the highly-modified device to conduct rigorous research to determine safety.

This wasn’t the case for most transvaginal mesh devices, and is the reason why women all over the world are stepping forward to hold manufacturers like C.R. Bard, Ethicon, American Medical Systems, and Boston Scientific accountable.

We can help you step forward.

Are you ready to share your transvaginal mesh story? We’re here to listen, and to help you.

Our experienced transvaginal mesh lawyers are available to discuss your case during a free consultation. We’ll guide you through your legal options, compensation eligibility, and whether filing a transvaginal mesh lawsuit is the right decision for you.

Contact Carey Danis & Lowe by phone at 800.721.2519, or by completing a confidential personal injury claim form.

We look forward to hearing from you soon.

TVM Dallas Case

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

Anterior-Vaginal-MeshEthicon, a branch of Johnson & Johnson, failed to disclose the dangers and complications linked to its Prosima vaginal mesh device. These statements were given by experts in Texas State Court in late September.

In the first court case involving Ethicon Inc.’s Prosima product, Dallas County District Court jurors were presented internal Ethicon documents that U.S. FDA specialists and urogynecology experts said showed the company was aware the product showed more risks and potential problems than Ethicon told doctors about.

By not disclosing the vaginal mesh risks, Ethicon is to blame for her pain and suffering, says Plaintiff Carol Cavness.

In heart-wrenching testimony, Ms. Cavness told the court how the agony and limitations caused by the Prosima vaginal mesh device affected her marriage to the point of divorce. The Prosima complications also continue to hinder her relationships with her children and grandchildren because she’s no longer physically able to join in activities with them.

In addition, Carol Cavness fears losing her airline mechanic job because the physical pain impairs her ability to perform heavy physical duties required by the job.

Three of the 6 cases filed against Ethicon over its pelvic mesh products have returned jury awards ranging from $1.2 to $11.1 million.

Carey Danis & Lowe seeks justice in medical product liability cases.

If you or a loved one has suffered complications related to the vaginal mesh Prosima device, compensation for pain and suffering may be due.

Our expert product liability attorneys will guide you through a free consultation and give you details about filing a Prosima mesh lawsuit.

Please contact Carey Danis & Lowe by calling 800.721.2519 or send us an email.

Vaginal Mesh Slings Fail in about 3 Percent of Incontinence Surgeries

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

Boston Scientific Ordered to Release Defective Transvaginal Mesh DocumentsBoston Scientific Ordered to Release Defective Transvaginal Mesh DocumentsA new study finds that about 1 in 30 women who opt for vaginal mesh implants need to remove or replace the devices within 10 years.

Patients fared best when sling operations were done by surgeons who performed the greatest volumes of surgeries.

The Journal of American Medical Association notes that in the United States, an estimated one in 7 adult females will have operations for urinary stress incontinence during their lifetime.

Research has linked the slings to mesh erosions, fistulas and chronic pain in the pelvic area and legs. Repairing the damage caused by vaginal slings, involves repeat surgeries to remove or replace the implants.

More than 50,000 women in the US have entered into class action lawsuits to recoup compensation for injuries caused by the mesh.

Carey Danis & Lowe seeks justice for those who have been harmed by vaginal mesh.

If you have pain and suffering related to a vaginal mesh implant, our product liability attorneys will guide you through your legal options.

During a free legal consultation, one of our defective medical device lawyers will walk you through compensation eligibility, and if applicable, the process of filing a vaginal mesh sling lawsuit.

To find out more about filing a vaginal mesh lawsuit, contact Carey Danis & Lowe by phone at 800.721.2519, or by completing a confidential personal injury claim.