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Articles Posted in Transvaginal Mesh

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

With the two-year statute of limitations ending in a number of US states, plaintiffs of transvaginal mesh lawsuits are rushing to get their cases in on time. Already, manufacturers are facing thousands of lawsuits from victims seeking damages for serious complications sustained. Included among the defendants: Boston Scientific Corp, CR Bard Inc., Johnson & Johnson subsidiary Ethicon Inc., American Medical Systems Inc., Cook Medical Inc., and Coloplast Corp.

Transvaginal mesh injury litigation submitted in federal courts is being consolidated for discovery in the U.S. District Court in the Southern District of West Virginia for multi-district litigation. According to media, in that court, Boston Scientific alone has been hit with over 6,300 related defective medical device complaints, with over half of them filed this year alone.

In Massachusetts, please contact our Boston transvaginal mesh injury lawyers to request your free case evaluation.

According to a new study by Russian scientists, younger women with less serious cases of pelvic organ prolapse and those who had hysterectomies appear to be more at risk of experiencing post-surgical complications after they are implanted with a vaginal mesh device than other patients. The scientists presented their findings at the annual Congress of the European Association of Urology earlier this year.

At Altman & Altman, LLP our Boston vaginal mesh injury lawyers represent women who have suffered serious health complications from an implant device. You may have grounds for a Massachusetts transvaginal mesh lawsuit against one of these manufacturers-Avaulta, Bard, Tyco, Sofradim, Gynecare, American Medical Systems, Boston Scientific, Johnson & Johnson’s Ethicon, Mentor, Uretex, and others. Vaginal mesh devices are also used to treat stress urinary incontinence.

The study group was comprised of 677 patients who underwent vaginal implant mesh procedures between 2006 and 2010 as part of their treatment for POP. One month after their surgeries, the scientists conducted follow up evaluations, and then again three months later. They found that 17% of the participants experienced vaginal mesh complications:

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