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TransVaginal Mesh Recall FAQs

transvaginal mesh recall FAQ

TransVaginal Mesh is a medical implant made of synthetic material, such as plastic, that resembles a fine net. The name “TransVaginal” derives from a method used to place the mesh between the bladder and the vaginal wall by surgically inserting it through the vagina.

The use of TransVaginal mesh promised relief for female conditions such as Stress Urinary Incontinence, Pelvic Organ Prolapse, Uterine Prolapse, Bladder Prolapse, Rectal Prolapse, Vaginal Vault Prolapse and Small Bowel Prolapse.

Mesh Products Are Available In both Biologic and Synthetic Form:

  • Vaginal mesh products on the market fall into the following four categories
  • non-absorbable synthetic (e.g., polypropylene or polyester);
  • absorbable synthetic (e.g., poly(lactic-co-glycolic acid) or poly(caprolactone) ;
  • biologic (e.g., acellular collagen derived from bovine or porcine sources) , and
  • composite (i.e., a combination of any of the previous three categories.

What is TransVaginal Mesh used for?

TransVaginal Mesh is often used to treat certain medical conditions that affect women. The most common use for TransVaginal mesh is to treat Pelvic Organ Prolapse (POP). This is a condition in which the muscles that hold a woman’s pelvic organs – such as her uterus and bladder – become weakened, causing the organs to bulge into the vaginal canal. POP can be brought on by childbirth, menopause, or surgery, such as a hysterectomy. TransVaginal Mesh can help prevent POP by supporting the pelvic muscles.

Another common condition TV mesh is used to treat is Stress Urinary Incontinence (SUI). SUI occurs when urine is involuntarily released due to weakened pelvic muscles. In patients with SUI, even everyday activities like coughing, sneezing, and laughing can cause the bladder to release urine. TransVaginal Mesh is used to support the pelvic muscles and alleviate pressure on the bladder.

What are the problems associated with TransVaginal Mesh implants?

TransVaginal Mesh was approved for use by the United States Food and Drug Administration (FDA) in 1996, but problems with the implants were quickly apparent. One of the most common issues is that the mesh eventually erodes and disintegrates. This erosion leaves behind sharp mesh fragments that can damage the nearby tissue and even perforate vital organs.

Because the eroded mesh often becomes entwined in the surrounding soft body tissue, it’s extremely difficult to surgically remove the mesh, making treatment a lengthy and painful process.

What types of injuries are caused by TransVaginal Mesh?

Common injuries associated with TransVaginal Mesh include:

  • Pain
  • Infection
  • Bleeding
  • Painful sexual intercourse
  • Vaginal scarring

Another common complication caused by eroded meshes is organ perforation. This happens when tiny pieces of the mesh break off and puncture a patient’s organs, causing internal injuries.

What are the dangers of TransVaginal Mesh devices?

Since TransVaginal Mesh devices were approved by the FDA in 1996, thousands of lawsuits have been brought forth against the manufacturers of these devices. The FDA has estimated that as many as 20 percent of all patients who received these implants have suffered from serious complications, and has since issued several reports addressing these issues while they investigate further.

Among the most serious complications arising from faulty TransVaginal mesh itself, faulty TransVaginal mesh surgery, and/or a combination of both are:

  • TransVaginal Mesh Organ Perforation: This occurs when the sharp edges of the mesh cuts through the vaginal wall and damages other internal organs. Surgery is required to rectify the problem.
  • TransVaginal Mesh Erosion: This condition occurs when the mesh degrades and/or passes through the vaginal wall of the woman resulting in significant pain, internal bleeding, nerve damage, and/or infection.

Additional complications concerning TransVaginal mesh are emotional problems, vaginal shrinkage and recurrence of prolapse or incontinence.

Has there been a TransVaginal Mesh recall?

In 2011, the FDA issued a warning that serious complications with the TransVaginal Mesh used for POP were more common than previously thought. The FDA also found that treating POP with the mesh was no more effective than other treatment and may even expose patients to more risk of injury. In addition, several manufacturers of the implants have recalled their TransVaginal Mesh products, the first being Boston Scientific which withdrew its mesh implants in 1999. Other companies that have voluntarily issued a mesh recall include Mentor Corporation, C.R. Bard, and Ethicon – a subsidiary of Johnson & Johnson.

Is the TransVaginal Mesh manufacturer liable for a patient’s injuries?

Manufacturers have a duty to ensure that their products are safe for consumers. If a patient is injured by a dangerously defective medical device, she may be able to recover damages for medical bills related to additional treatment, lost wages, and pain and suffering that resulted from the injury. Even if the mesh you received wasn’t part of a TransVaginal Mesh recall, the manufacturer may still be liable for your injuries.

Are there any lawsuits related to TransVaginal Mesh injuries?

Currently, there are lawsuits pending against six manufacturers of TransVaginal Mesh implants:

The cases against each of these companies have been consolidated in a process called multidistrict litigation, or MDL. This means that no matter where a case against a TransVaginal Mesh manufacturer was filed it will be heard first in one location by a single federal judge.

What TransVaginal Mesh symptoms should I be on the lookout for?

There are two primary symptoms that you should be aware of: vaginal pain and pelvic pain. Other symptoms include, but are not limited to:

  • Mesh erosion into the vaginal canal, bladder or bowel
  • Urinary problems including increased incontinence or difficulty voiding
  • Mesh infection
  • Patch bleeding, bleeding
  • Inability to have and severe pain during sexual intercourse
  • Lower back pain, pain on one side of the body
  • Potential for severing the bladder or bowel
  • Recurrence of prolapse or incontinence
  • Bladder, bowel and blood vessel perforations
  • Discomfort and pain (including pain during sex)
  • Vaginal scarring
  • Neurological problems
  • Abdominal discomfort
  • Difficulty standing for long periods
  • Depression and psychological reactions
  • Bowel problems

If you experience any of these symptoms, contact your physician right away.

What can I do if I’ve been injured by a TransVaginal Mesh implant?

If you’ve been injured by a TransVaginal Mesh implant you may be able to receive compensation. A product liability lawyer can inform you about your legal options. However, a law called a statute of limitations will limit the time period you have to file a lawsuit. You should also periodically check the FDA’s website to determine whether your implant has been part of a TV mesh recall.

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