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POP Archives - Carey Danis & Lowe

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.

ASK A LAWYER

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.

Despite Current Safety Concerns, FDA Approves Newest Pelvic Mesh Product

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

Boston Scientific Ordered to Release Defective Transvaginal Mesh DocumentsBoston Scientific Ordered to Release Defective Transvaginal Mesh DocumentsThe US FDA approved Caldera Medical’s latest version of Vertessa Lite mesh in June 2015, even though there is ongoing controversy about the safety of these type of devices.

Caldera Medical, a startup, makes the product to treat Pelvic Organ Prolapse (POP). The large pore mesh corrects the position of vagina after pelvic organs have bulged into the top of the vagina.

On the flip side of this approval is the fact that another mesh manufacturer, Medtronic, recently paid a huge settlement for more than 11,000 vaginal mesh victims.

The FDA has known since 2011 that dire problems result from transvaginal repair for Pelvic Organ Prolapse.

Indeed, they are considering reclassifying pelvic mesh from a moderate risk or class II device, to the more stringent class III device which necessitates a premarket approval (PMA) application.

The premarket approval application will require manufacturers to provide clinical data to show a reasonable assurance of safety and effectiveness for transvaginal mesh used in POP repair.

Unfortunately, with the recent approval of the updated mesh product, Caldera Medical hasn’t been subject to these more stringent testing procedures. The company is one of many named in more than 70,000 lawsuits regarding transvaginal mesh.

The FDA says that the most common problems with these mesh products are erosion through vaginal epithelium, infection, pain, urinary problems and recurrence of prolapse and/or incontinence.

Cary Danis & Lowe will fight pharmaceutical companies on your behalf.

Our attorneys represent women who have suffered emotionally and physically from defective transvaginal mesh. We continue to research cases and are available to discuss your case during a free case evaluation.

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

Transvaginal Mesh Lawsuit Update: C.R. Bard Settles a Case

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

transvaginalmeshlawsuitC.R. Bard, a manufacturer of medical devices used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), recently settled a vaginal mesh lawsuit. Selected as a bellwether case, the lawsuit involved the plaintiff, Debra Wise.

The bellwether trial was scheduled to begin on February 18, 2015 in the U.S. District Court for the Southern District of West Virginia as part of the C.R. Bard multidistrict litigation (MDL).

According to a report by Reuters on C.R. Bard’s decision, the settlement amount is unknown.

The fact that C.R. Bard decided to settle a bellwether case is a positive sign for plaintiffs.

Additionally, the mesh manufacturer’s decision could have been influenced by the presiding judge. Carey Danis & Lowe recently reported that Judge Joseph R. Goodwin, who is overseeing the 7 mesh MDLs, urged mesh manufacturers to consider settling the tens of thousands of pending transvaginal mesh lawsuits.

Legal Assistance

If you or someone you love sustained an injury due to vaginal mesh complications, such as mesh erosion, Carey Danis & Lowe is here to help. During a free, no obligation case evaluation, we will guide you through your legal options, and determine your compensation eligibility.

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

Boston Scientific to Pay $26.7M in Miami Transvaginal Mesh Lawsuit

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

tvmBoston Scientific, the company behind such products as Pinnacle transvaginal mesh, must pay $26.7 million in a transvaginal mesh lawsuit in Miami. After a deliberation period lasting only a few hours, jurors decided that Boston Scientific was neglectful in developing the Pinnacle, and in educating healthcare providers and patients on health risks.

The Miami case involved four plaintiffs, whose lawsuits had been transferred to Florida from the multidistrict litigation (MDL) in West Virginia. The four women each received implants of the Boston Scientific Pinnacle device to treat either pelvic organ prolapse (POP) or stress urinary incontinence (SUI).

As a result of the Pinnacle implant, they suffered life-changing, debilitating health issues, among them bleeding and infection.

Carey Danis & Lowe represent women who have also suffered transvaginal mesh injuries. As a result, our defective medical device lawyers are intimately familiar with the pain and suffering caused by these products.

Safety Studies Never Conducted

According to an article published by Reuters, Boston Scientific did not complete safety studies on the Pinnacle, most likely in an effort to acquire market share, and beat out its competitors. It is possible that the company deemed safety studies irrelevant in light of the type of mesh used to make the Pinnacle.

During the Miami trial, it was revealed that Boston Scientific used mesh manufactured by another company that explicitly warned against using the mesh for medical purposes.

 

Still, the Boston Scientific legal team contended that the mesh used in the Pinnacle had been used by doctors for years, and was carefully manufactured by engineers. Nevertheless, the product’s manufacturer did not design the mesh to be used internally, so that should have been reason enough to look elsewhere for a medical grade material.

 

 

Our View

 

The Miami case being decided in favor of the plaintiffs is a clear indication that Boston Scientific acted thoughtlessly in manufacturing and distributing the Pinnacle. Carey Danis & Lowe is pleased that the plaintiffs got their day in court to share their story, and to hold accountable a company with negligent business practices.

 

 

Providing Legal Assistance to Transvaginal Mesh Users

Carey Danis & Lowe currently represents women across the U.S. who have been injured by transvaginal mesh, including the Boston Scientific Pinnacle. If you believe that your injuries and losses are related to your transvaginal mesh implant, we urge you to explore your legal options and compensation eligibility.

 

During a free, no-obligation case evaluation, our defective medical device lawyers will offer you our professional advice on how to move forward with your case.

 

Share your transvaginal mesh story with Carey Danis & Lowe today. You can reach our law offices by phone at 800.721.2519, or by completing a confidential personal injury claim form.

American Medical Systems Begins Vaginal Mesh Study

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

ams_transvaginal_mesh_lawsuit_settlementsAs mandated by the U.S. Food and Drug Administration (FDA), American Medical Systems (AMS) has started its transvaginal mesh study by enrolling its first participant. The transvaginal mesh manufacturer announced the enrollment in a press release published by the Wall Street Journal.

According to the press release, the AMS study will take place over a period of five years, with two years designated as an enrollment period, and the remaining three years allotted for tracking patient health. The study is to look at the AMS transvaginal mesh product, Elevate (TM) Anterior and Apical Prolapse Repair System.

Though news of the AMS transvaginal mesh study is a welcome announcement, such an in-depth examination of the health effects of transvaginal mesh for the treatment of pelvic organ prolapse (POP) would have best been conducted prior to releasing these types of products onto the market.

Carey Danis & Lowe Represents Victims

A law firm headquartered in St. Louis, Carey Danis & Lowe is dedicated to providing their expert legal assistance to victims of transvaginal mesh. Our team of defective medical device and personal injury lawyers understand the pain and suffering that individuals and families endure in the wake of injuries from a defective product. If you or someone you love has been injured by transvaginal mesh, work with a team of lawyers that are committed to your case.

Explore your legal options and compensation eligibility with a Carey Danis & Lowe lawyer today. Our initial consultations are free.

Vaginal Mesh Injuries Chronicled by Minneapolis Newspaper

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

transvaginal_mesh_mdl_2013_settlements_side_effects_court_filing_lawsuitsA report published in May 2014 by the Minneapolis newspaper, Star Tribune, highlighted the risks of using transvaginal mesh to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). A urogynecologist interviewed for the story noted that treating POP with transvaginal mesh has been known to negatively impact a patient’s overall health and well being.

In certain cases, the post-surgery experience has presented a much more difficult reality than living with untreated POP or SUI. Patients who have been severely injured by transvaginal mesh point to mesh erosion as the primary cause for their physical and emotional suffering.

Because there appears to be significant risks involved with using transvaginal mesh, the urogynecologist, Dr. Elizabeth Frank of Park Nicollet Women’s Center, does not use this surgical device to treat POP or SUI. Instead, Dr. Frank opts for other methods that have proven to be safer for patients.

Carey Danis & Lowe Can Help You

As a national law firm specializing in defective medical device litigation, Carey Danis & Lowe has the legal expertise to assist you with your transvaginal mesh case, and can determine if you will be eligible for compensation. If you have been injured by transvaginal mesh, contact a defective medical device lawyer at Carey Danis & Lowe for a free case evaluation.

Share your transvaginal mesh story with a lawyer at Carey Danis & Lowe today. Contact us by phone at 800.721.2519, or by submitting a personal injury claim form.

Transvaginal Mesh Safety in Canada

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

transvaginal_mesh_lawsuits_canadaHealth Canada, the Canadian equivalent of the U.S. Food and Drug Administration (FDA), issued an announcement in early May 2014 with new information on transvaginal mesh. Their announcement pertained specifically to those mesh devices used in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

Health Canada supplied a list of health complications that are often identified in patient reports. Patients have suffered from:

  • chronic pain
  • dyspareunia, or painful intercourse
  • mesh erosion
  • mesh contraction
  • infection
  • internal damages caused by mesh implant
  • bleeding
  • return of POP and SUI symptoms
  • reparative surgeries following damage from defective mesh

The Canadian medical devices regulator is considering if updates to safety information for transvaginal mesh products will be necessary, according to their news release.

Carey Danis & Lowe Is Here to Help You

If any of the complications mentioned above is descriptive of your injury, Carey Danis & Lowe is here to help you. As a law firm headquartered in St. Louis that specializes in defective medical device litigation, Carey Danis & Lowe can guide you through the process of filing a lawsuit targeted at the manufacturer of your particular transvaginal mesh device.

Our experienced personal injury lawyers are available to hear your transvaginal mesh story during a free case evaluation.

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

FDA Presents New Transvaginal Mesh Orders

By | Defective Medical Device litigation, Product Liability, Transvaginal Mesh, Uncategorized

fdaThe U.S. Food & Drug Administration (FDA) announced in a news release dated April 29, 2014 that it would put forth two orders relating to transvaginal mesh used to treat women with pelvic organ prolapse (POP). The two orders have not been made final, and the FDA is accepting feedback on their propositions over a three month period.

One of the orders recommends updating the classification of transvaginal mesh for POP so that it accurately reflects the health risks caused by these medical devices. In their April news release, the FDA advises that transvaginal mesh be classified as class III, meaning that it is a high-risk device. The FDA currently classifies transvaginal mesh for POP as a class II device, which denotes that the device poses a moderate risk to the patient’s health and safety.

A number of the transvaginal mesh products that have been sold in the U.S. were brought to market using an expedited FDA approval process known as the 510(k) application. Medical device manufacturers, such as Johnson & Johnson and their subsidiary Ethicon, use the 510(k) process to introduce new products onto the market that are updated versions of an FDA approved device. In some cases, due to similarities between two products, companies do not submit extensive safety information.

Now that transvaginal mesh injuries have become evident, the FDA proposes that any new transvaginal mesh products seeking approval to treat POP must submit a premarket approval application. This application would require manufacturers to collect and submit thorough data about the new product from a premarket clinical trial.

Carey Danis & Lowe Represents Victims

Transvaginal mesh injuries can be life-changing. Our attorneys recognize the pain and suffering endured by women and families impacted by transvaginal mesh.

The defective medical device lawyers at Carey Danis & Lowe represent individuals and families who have been negatively impacted by certain medical devices, including transvaginal mesh. We are currently investigating transvaginal mesh cases. If you have been injured by mesh, Carey Danis & Lowe encourages you to begin exploring your legal options and compensation eligibility. We offer free initial case evaluations.

Share your transvaginal mesh story with Carey Danis & Lowe today by calling 800.721.2519, or by completing one of our personal injury claim forms.

New Zealand Women Injured by Vaginal Mesh Call for Safety Review

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

Boston Scientific Ordered to Release Defective Transvaginal Mesh DocumentsBoston Scientific Ordered to Release Defective Transvaginal Mesh DocumentsAfter experiencing complications with their transvaginal mesh implants, two New Zealand women are reaching out to their government for assistance.

One of the women, Carmel Berry, explained how she had undergone surgery to remove the defective transvaginal mesh, which proved challenging upon the discovery that parts of the implant had joined with surrounding tissue making removal both difficult and dangerous.

The other woman, Charlotte Korte, was able to have all of her transvaginal mesh removed after experiencing difficulty standing for more than two minutes.

Both of the women received transvaginal mesh implants to repair a condition known as pelvic organ prolapse (POP).

The women are calling for New Zealand’s government to undertake a safety review of transvaginal mesh products currently on the market, especially those being used in patients. They believe that it is of the utmost importance to collect more data on these products to come to a firm understanding of whether they are safe to use in POP repairs.

The two women were profiled in an article written for New Zealand’s 3 News. The article explains that in New Zealand over 400 individuals have filed claims alleging injury from transvaginal mesh products, with about 100 of these cases being rejected for reasons unexplained in the article.

Carey Danis & Lowe Can Help You

As the stories of these two women illustrate, transvaginal mesh implants have negatively impacted the lives of so many, leaving some with permanent injuries.

Carey Danis & Lowe is a national law firm based in St. Louis that represents victims of defective medical devices. We find it encouraging that these two women have stepped forward to raise awareness about transvaginal mesh injuries through reaching out to their government.

If you have been injured by transvaginal mesh, Carey Danis & Lowe can help. We offer free initial case evaluations during which we help you explore your legal options and compensation eligibility.

Share your transvaginal mesh story with us today. Contact Carey Danis & Lowe by phone at 800.721.2519, or by completing one of our confidential personal injury claim forms.

Stay up-to-date on the latest transvaginal mesh lawsuit news by following the Carey Danis & Lowe blog.

Ethicon Gynecare Prolift History & Lawsuit Background

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

ethicon johson johnsonTransvaginal mesh is used to treat patients with pelvic organ prolapse (POP) and stress urinary incontinence (SUI). As a national law firm representing individuals who believe their injuries (stem) from transvaginal mesh implants, Carey Danis & Lowe is invested in providing out clients and those who would like to learn more about transvaginal mesh with a comprehensive background of this product.

The following review of Ethicon’s Gynecare Prolift transvaginal mesh device contextualizes the mounting lawsuits targeted at this medical device manufacturer.

In March 2005, Ethicon, a unit of Johnson & Johnson, ushered the Gynecare Prolift transvaginal mesh device onto the medical device market. In marketing the mesh, Ethicon promoted it as an state-of-the-art device with successful outcomes.

According to Bloomberg, Ethicon sold the Gynecare Prolift for three years without approval from the U.S. Food and Drug Administration (FDA). Ethicon reasoned that the Prolift model was similar enough to an existing FDA approved product, the Gynecare Gynemesh device, that requesting FDA approval was unnecessary.

However, after learning about the Prolift model in 2007, the FDA deemed the unsanctioned release of the Prolift as unacceptable.

Even so, the FDA granted approval of Ethicon’s Gynecare Prolift in May 2008.

In 2011, three years after the Prolift’s approval, the FDA received strong recommendations from an advisory body to categorize transvaginal mesh as causing significant harm. They also advised that more research was necessary in order to determine the safety of transvaginal mesh, and that this research should involve human subjects.

In January 2012, the FDA ordered makers of transvaginal mesh to conduct studies of mesh related injuries, among them damage to organs. This order was directed at Ethicon and thirty other mesh manufacturers.

Later in 2012, Ethicon initiated a Gynecare Prolift recall. They also removed three other transvaginal mesh products off of the market, the Prolift+ M, TVT Secur, and Prosima.

In justifying its recall, Ethicon claimed the action was not influenced by mounting lawsuits or reported health complications, but instead with market viability.

Also in 2012, transvaginal mesh lawsuits were consolidated into a multidistrict litigation (MDL) in the U.S. District Court for the Southern District of West Virginia before U.S. District Judge Joseph R. Goodwin. The litigation is In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation MDL No. 2327.

As of early October 2013, there are currently 10,400 vaginal mesh lawsuits targeted at Ethicon and their transvaginal mesh products in the West Virginia MDL.

These lawsuits claim that Ethicon’s transvaginal mesh products, including the Gynecare Prolift, caused serious injuries. More specifically, women have faulted the mesh for bleeding, pelvic area pain, infection, and painful intercourse. Furthermore, the FDA has cited mesh erosion and mesh contraction as the two transvaginal mesh injuries reported with the most frequency.

The St. Louis class action attorneys at Carey Danis & Lowe are currently accepting transvaginal mesh cases, and are providing free legal evaluations. In addition, individuals who have questions about transvaginal mesh and health complications can pose those questions to our on-staff medical experts. Our team is here to support you with expert legal and medical advice.

 

Share you transvaginal mesh story with Carey Danis & Lowe by calling 800.721.2519, or by completing a confidential personal injury claim form.