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The Truth About Transvaginal Mesh

The FDA now warns that vaginal mesh complications are not rare events

You had the surgery because you simply couldn’t lead the kind of life that you wanted to lead without medical help. Your pelvic organ prolapse or stress urinary incontinence caused you pain, embarrassment, or interfered with your daily life. Your doctor suggested a transvaginal mesh surgery and you agreed, but your quality of life may not have improved in the ways that you expected. Instead, you may be at risk of suffering serious side effects from your vaginal mesh surgery that further complicate your life and cause you pain.

Eight Risks of Transvaginal Mesh Surgery

Whether you have already had transvaginal mesh surgery or are considering the procedure, it is important to know the risks that you may face. Specific side effects may include:

  1. Infection.
  2. Bleeding.
  3. Scarring.
  4. Narrowing of the vaginal walls.
  5. Recurrence of the urinary incontinence or pelvic organ prolapse you were trying to treat.
  6. Painful intercourse.
  7. Pain.
  8. Other complications.

These side effects may occur if the mesh erodes through the vaginal wall, the mesh shrinks, or the mesh otherwise does not perform as expected. According to the FDA,  transvaginal mesh complications are not considered to be rare and each woman considering such an operation should have a conversation with her doctor about the specific need for surgical mesh to treat her condition, as opposed to other treatment options.

Symptoms of a Transvaginal Mesh Problem

If you have a vaginal mesh implant then it is important to be aware of potential signs of a serious side effect. Those signs include:

  • Mesh erosion through the vaginal wall, urethra, bladder, or bowel.
  • Bleeding.
  • Urinary tract infections.
  • Swelling.
  • Itching.
  • Clear, slimy discharge.
  • Internal and external abscesses.
  • Pain in lower back.
  • Scar tissue.

If you experience any of these symptoms, it is important to speak with your doctor as soon as possible. Failing to do so may result in further complications. Your doctor will be able to tell you the next steps to take to protect your health.

FDA Action on Transvaginal Mesh

The FDA issued its first safety update about transvaginal mesh in 2008 when it identified potential dangers associated with these medical devices. Since then, the FDA has taken the following actions:

  • In 2011 the U.S. Food and Drug Administration’s Obstetrics and Gynecological Devices Panel recommended that transvaginal mesh products be reclassified from moderate-risk to high-risk products. The panel also recommended that transvaginal mesh manufacturers be required to submit premarket approval applications so that the safety and effectiveness of these medical devices could be evaluated before the products were sold.
     
  • In July 2011, the FDA issued a safety update about transvaginal mesh. In this update the FDA acknowledged that complications were not rare As part of that update, the FDA recommended that women who have had surgery do the following: have regular checkups, notify their doctors of any complications, let all healthcare providers know about their surgical mesh implants, and talk to their doctors about concerns.
     
  • In April 2014, the FDA issued a press release claiming that it has identified clear risks associated with transvaginal mesh and is proposing to address those risks.
     
  • In January 2016, the FDA issued two orders. The first reclassified transvaginal mesh used to repair pelvic organ prolapse from a class II medical device (used for moderate-risk devices) to a class III medical device (which includes high-risk devices). The second order required transvaginal mesh manufacturers to submit premarket approval applications regarding the safety and effectiveness of using mesh to treat pelvic organ prolapse.

Despite these FDA actions, women have continued to be hurt by transvaginal mesh products.

If You Were Hurt, Then Doctors and Class Action Lawyers May Help Your Recovery

You are likely to need medical help in order to recover from your transvaginal mesh complications. An experienced doctor can evaluate your specific case and make recommendations about your care. Surgery may be required to remove the mesh and repair your injury.

An experienced medical device injury attorney may also be able to help you if you have been hurt by fighting to get you the financial recovery that you deserve.

You shouldn’t have to suffer through the pain of a complication and the expense of another surgery without help. You have suffered enough. Now it is time to let someone help you recover so that you can get back to leading the kind of life that you want to lead.

Please call our class action law firm today at 1-800-800-5678 for more information about your rights and your potential recovery.

Jason F. Abraham
Managing Partner, Hupy and Abraham

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