Articles Posted in Transvaginal Mesh

Surgical hernia mesh is a medical implement commonly used to support the body during and after a surgery performed to fix a hernia – which is a tearing or protrusion of an internal organ or muscle. Hernia mesh has been utilized for many years, but can cause serious harm to patients, either due to medical malpractice or faulty mesh products. If you or a loved one suffered additional injury from the use of surgical hernia mesh, contact the personal injury attorneys at Altman & Altman LLP today.

Many hernia mesh products have been recalled or withdrawn from the market by the Food and Drug Administration (FDA) due to their high failure rates and high occurrence of painful side effects, such as:

• Damage caused by shrinking, degrading (oxidizing) or migrating mesh products
• Blockages to intestines
• Autoimmune reactions or total rejection of the mesh by the body
• Failure to prevent reoccurrence of the hernia
• Development of fistulas – which are irregular connections made between organs that are intended to stay separated
• Further organ tears or perforations as a result of the mesh

If you or a loved one experienced any of these types of incidents, you may be entitled to financial compensation, which can help offset the costs of resulting medical expenses, make up for lost wages due to being unable to work during extended recovery times, or to simply keep your mind at ease about not making money while you get back to normal.

What exactly is hernia mesh?

Hernia mesh is most often made from synthetic material – most commonly polypropylene – which is manmade material that, for decades, has been marketed as a safe choice that will not degrade or otherwise cause harm once it is inside the body. However, scientific studies have begun to show evidence on the contrary and Physiomesh, one of the leading brands of polypropylene mesh – made by Johnson & Johnson subsidiary Ethicon – was withdrawn from the market in 2016 for this reason.

Hernia mesh is intended to reduce the frequency of reoccurrence of a hernia – which occur most often following an injury involving high levels of strain on the body. Hernias can happen to anybody, and for a number of reasons, including:

• Advancing age causing weakness in organs and muscles
• Lifting of heavy objects
• Intense coughing or sneezing fits
• Pregnancy
• Complications related to obesity
• Poor nutritional health
• Pre-existing connective tissue disorders

Corrective hernia surgeries can be accomplished with or without the use of hernia surgical mesh, but utilization of the mesh is supposed to reduce the frequency in which a hernia could be reaggravated by holding the repair in place and giving it time to adequately heal. Unfortunately, the mesh comes with its own risks attached – and those risks can be amplified if a doctor exercises negligent medical malpractice in its application or if the mesh isn’t properly treated before being placed, which can result in oxidation and degradation of the material, causing issues like those mentioned earlier. Continue reading

In November 2014, four women were awarded $18.5 million in damages for serious complications they suffered due to dangerous transvaginal mesh devices. A jury found that Boston Scientific Corp.’s Obtryx Transobturator mesh device was defectively designed. Boston Scientific appealed the verdict, claiming that the consolidated nature of the four cases resulted in juror confusion and prejudice.

Earlier this month, a federal appeals court upheld the verdict, citing Boston Scientific’s failure to provide evidence of confusion or prejudice.

“Here, there is little reason to be suspicious of the verdicts given that BSC had a chance to fully develop its defenses and that the judge properly instructed the jury throughout the trial to keep the cases separate,” wrote the Court. “What is more, the four plaintiffs did not receive identical damage awards, but instead received damages that varied by $1 million across plaintiffs. That the total damages awards were of the same order of magnitude appears to reflect the very similarities between the cases that justified consolidation in the first place.” A Boston defective medical products attorney can help you determine how to proceed if you’ve been harmed.

Sadly, Boston Scientific is far from the only company accused of manufacturing and marketing dangerous transvaginal and pelvic mesh. These devices are typically used to treat stress urinary incontinence and pelvic organ prolapse, two painful and embarrassing conditions that affect nearly 50 percent of post-menopausal women. But Boston Scientific is among the worst offenders, admitting that it is facing more than 48,000 liability claims due to the defective implants. In 2015, Boston Scientific agreed to settle nearly 3,000 cases to the tune of about $119 million.

Why is Transvaginal Mesh So Dangerous?

Transvaginal mesh has been linked to serious complications in tens of thousands of women. The complications range from severe pain and vaginal scarring to nerve damage and organ perforation. The most common serious complications include:

• Pain
• Infection
• Pain during intercourse
• Organ perforation
• Erosion
• Urinary problems
• Scarring
• Nerve damage
• Fistulas
• Autoimmune problems
• The need for revision surgery

In 2008, the FDA began investigating the growing list of adverse event reports. In 2011, the agency issued a warning that complications associated with mesh devices were not rare, as previously thought. And in 2016, transvaginal mesh devices were reclassified as Class III (high risk) by the FDA. A MA injury lawyer can help you recover damages if you’ve been injured by a transvaginal mesh device.

Hope for the Future

Scientists from the University of Sheffield have developed an alternative to the dangerous mesh products on the market today. There is mounting evidence that softer, more elastic materials are better for use in the pelvic area. Further, a device that releases estrogen can help the body to heal more effectively. As such, scientists at the university’s Material Science and Engineering department have developed a polyurethane-based device, which is more elastic than its polypropylene predecessor. Continue reading

Women may develop medical conditions such as urinary incontinence or pelvic organ prolapse due to age, childbirth, or after having a hysterectomy. These conditions may cause the pelvic organs to slip into the vaginal canal, resulting in discomfort and other medical complications. Many of these women will undergo a surgical procedure using transvaginal mesh to correct the problem. Unfortunately, transvaginal mesh is linked to serious pain and a long list of medical complications.

What is Transvaginal Mesh?

Made from a synthetic substance called polypropylene, transvaginal mesh is a small, net-like device that is surgically implanted into the vagina to hold pelvic organs in place. This type of mesh was first used to treat hernias, beginning in the 1950s. It was approved by the FDA to treat pelvic organ prolapse and urinary incontinence in 1996. However, the FDA did not require that manufacturers conduct safety studies on humans prior to the device’s release. Further, many transvaginal mesh products were modeled after a device called the ProtoGen Sling, which  was recalled due to high erosion rates in 1999.

Transvaginal Mesh Complications

In 2011, the FDA reported that it had received 4,000 adverse event reports linked to transvaginal mesh products. Despite the many complications, surgeries to implant transvaginal mesh continue with shocking frequency. The following complications are associated with mesh products:

• Erosion of the mesh itself
• Erosion of surrounding vaginal tissue
• Severe pain in the pelvic area
• Pain during intercourse
• Bleeding
• Infection
• Urinary incontinence
• Perforation of surrounding organs, including the bladder and bowel
• Perforation of blood vessels
• Scarring
• Fistulas
• The need for revision surgery

Transvaginal mesh is intended to remain in the body permanently. As such, revision surgeries can be exceptionally difficult. In layman’s terms, they can be costly and quite painful. In many cases, the mesh has to be removed in pieces, and the revision surgery often has to be performed by a specialized doctor. A Boston defective medical products attorney can help you determine how to proceed if you’ve been injured by transvaginal mesh or a similar device.

Transvaginal Mesh Implants “Cannot be Recommended”

According to a report published in the Journal of Obstetrics and Gynecology, more than 15 percent of patients who have been implanted with transvaginal mesh have suffered from severe pain and infections due to tissue erosion. The article’s authors write that: “Surgeons should be aware of the potential complications of synthetic meshes. Until data on the safety and efficacy of the intravaginal slingplasties are available, these procedures cannot be recommended.”

Talk to Your Doctor

If you are considering getting a transvaginal mesh implant, it is in your best interest to speak with your health care provider about the risks. If you currently have a transvaginal mesh implant and are experiencing side effects, such as bleeding or pain, seek immediate medical attention. A MA defective medical device attorney can help you recover damages if you’ve been injured by any type of mesh device. Continue reading

Women diagnosed with pelvic organ prolapse or stress urinary incontinence may have transvaginal mesh devices implanted during surgery to repair the damage. This plastic, net-like material made of polypropylene, also known as urogynecologic surgical mesh, has caused health issues in thousands of patients. These health problems typically occur because of faulty product design or improper surgical implantation technique. While the mesh can be implanted via abdominal surgery, vaginal implantation is the more common route for women suffering from pelvic floor disorders. Vaginal implantation is far less invasive than traditional surgery, with less time spent in the operating room. Contact a Boston Defective Medical Device Lawyer Today.

Pelvic Floor Disorders

Pelvic floor disorders generally occur after childbirth or hysterectomy, or in postmenopausal women. Prolapse is usually due to weakening of the pelvic muscles, which allows the uterus, bladder or rectum to enter the vagina. Surgeons use prepackaged transvaginal mesh kits to repair the prolapse. The problems experienced by women undergoing these procedures are directly linked to certain manufacturers. Currently, C.R. Bard, Ethicon, and Boston Scientific are facing the majority of injury lawsuits for mesh devices.

Johnson & Johnson, the parent company of transvaginal mesh manufacturer Ethicon, has agreed to settle four mesh implant injury lawsuits. These are the first of many settlements filed against the J & J unit involving claims alleging that its mesh medical device caused injury to thousands of women. There are about 23,000 transvaginal mesh cases pending against the company right now.

The terms of the settlements reached are confidential. However, J & J was clear to note that the resolutions are not an admission of wrongdoing related to the making or marketing of the mesh implant devices.

Tens of thousands of women have filed transvaginal mesh cases claiming the devices caused them serious injuries. The devices are designed to treat pelvic organ prolapse and stress urinary incontinence, which are known to especially affect women after childbirth or a hysterectomy or during menopause. The device is surgically implanted abdominally or transvaginally.

Jurors have ordered Boston Scientific Corp. to pay Martha Salazar $73 million for injuries she sustained from the Obtryx sling, which is a vaginal mesh implant. This is the first defective medical device award against the company over its incontinence slings. (The Massachusetts-based device maker won the first two cases to go to trial over the Obtryx sling.) It is facing over 23,000 more transvaginal mesh implant lawsuits.

Salazar, 42, was implanted with the Obtryx sling in 2010 after she began to experience urinary leakage. She claims the medical device eroded in her body and that this has left her with constant pelvic pain and permanent nerve damage. Salazar also says that she cannot exercise, walk, or sit normally.

In her Obtryx sling lawsuit, Salazar accused Boston Scientific of designing and promoting a product that it was aware was flawed. The company has denied the allegations.

A federal judge has issued a ruling in a pelvic mesh injury case against manufacturer C.R. Bard from a plaintiff whose injuries occurred nearly two decades ago. Judge Joel H. Slomsky upheld the woman’s negligent manufacturing and failure to warn claims while dismissing other allegations, including those contending that the medical device had a manufacturing defect. Slomsky said that even if certain products cannot be made safe, this does not automatically mean they were made defective. C.R. Bard had sought to have the entire products liability case dismissed.

The plaintiff underwent surgery in 1996 for bilateral ventral hernias. C.R. Bard’s Marlex mesh was used in the procedure. During the surgery, she contends, she experienced abdominal pain. The following year, the woman went to an E.R. because she was experiencing severe diarrhea, vaginal bleeding, abdominal pain, and dizziness. She says that doctor there was unable to diagnose her symptoms and that she continued to experience symptoms because of the mesh product for years.

Abdominal abscesses were found in her body in 2011. During exploratory surgery, the surgeon discovered that the mesh product had perforated internal structures in the woman’s body. Some of the mesh was removed but not everything. Instead, the plaintiffs’ appendix had to be taken out and she also underwent bowel resection surgery.

Endo Health Solutions says it will pay approximately $830 million (pretax) to resolve about 20,000 vaginal mesh complaints against it. The manufacturer acquired American Medical Systems Holding Inc., which makes the mesh implants, in 2011.

As of late February both companies were contending with about 22,000 defective medical device cases over the transvaginal products. Among the Endo devices included in the settlement are the Elevate, Apogee, and Perigee implants.

The implanting transvaginal mesh devices was initially seen as an enhanced alternative to tradition surgery to repair POP (pelvic organ prolapse.) However, the US Food and Drug Administration began to take notice a few years ago that there were a lot of women complaining that the mesh devices had caused them serious complications.

With the number of transvaginal mesh cases continuing to grow-some believe that the quantity of claimants could reach over 100,000. Currently, there are over 40,000 defective medical device claims in federal and state courts involving plaintiffs seeking compensation against American Medical Systems Inc., Johnson & Johnson Inc., Ethicon Inc., American Medical Systems, CR Bard Inc., Gynecare, Tyco, Covidien, Mentor, Sofradim, and others.

Vaginal mesh devices are used to treat Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP) in women. In 2008, the Food and Drug Administration put out a Public Health Notification letting the public know that using this type of mesh product in medical procedures could cause injuries, including bleeding, infection, pain, recurring incontinence/prolapse, and other complications. The FDA followed up with another update in 2011 stating that “serious complications” from transvaginal mesh are not rare and the device does not enhance the chances of a successful outcome more than traditional procedures that don’t use mesh devices.

In other recent transvaginal mesh injury news, a judge says that Johnson & Johnson destroyed thousands of files about vaginal mesh implants. In West Virginia, U.S. magistrate judge Cheryl Eifert, where vaginal mesh lawsuits have been consolidated for pre-trial hearings, found that the manufacturer’s Ethicon unit, which manufactures TVT Retropubic and Gynecare Prolift meshes, destroyed or lost thousands of computer files and documents about the devices going back as far as 2007.

The Massachusetts Appeals Court says that the vaginal mesh lawsuit that was dismissed by the Suffolk County Superior Court can proceed. The lower court had said that the plaintiff failed to satisfy pleading standards. However, the appeals court disagrees.

The plaintiff, Billie Allen, is seeking damages from Boston Scientific and American Medical System (Endo Health Solutions). She claims that she experienced the side effects of pain, mesh erosion, and vaginal scarring after she was implanted with their devices.

Vaginal Mesh Cases