Transvaginal Mesh Complications

Transvaginal Surgical Mesh | The Maher Law FirmThere may be a Transvaginal Mesh recall to prevent future damages

The FDA (Food and Drug Administration) is reviewing thousands of transvaginal mesh injury cases, including severe injury and death cases.

Doctors from across the country testified before the Food and Drug Administration’s Obstetrics and Gynecology Device Advisory Committee in September 2011 in regards to the POP (Pelvic Organ Prolapse) procedure, citing injury and even death from the procedure.

According to the FDA, issues arising due to transvaginal mesh complications are as high as 10% of patients who received the surgery within a one year period.  In fact, between 2005 and 2010 the FDA received almost 4,000 reports of complications and 3 deaths related to transvaginal mesh products.

Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group said, “Given the absence of evidence for clinically significant benefit and the overwhelming evidence of very serious, common risks, use of synthetic surgical mesh products for transvaginal repair of POP is not ethically justifiable.”

Transvaginal mesh products are currently classified as a Class III device, but the FDA may take a harder stance on the product due to the legal and governmental spotlight.

Today, Transvaginal Mesh Recalls Include:

  • Gynecare Prolift Kit
  • Gynecare Prolift + M Kit
  • Gynecare TVT Secure
  • Gynecare Prosima Pelvic Floor Repair System Kit

One Women’s Transvaginal Mesh Story:

In an article by Jane Akre, a writer for –  Mesh Medical Device News Desk, regarding a patient by the name of Hope Pagano – a mortgage broker from Long Island;  Jane Akre documents the life altering trauma Mrs. Pagano went through after her Gynecare surgical procedure in which Mrs. Pagano said  ”I got what I thought was the flu three weeks after my surgery and it never seemed to go away.”  Later, she was diagnosed with having Systemic Lupus Erythematosus (SLE), which is a long term autoimmune disease that usually takes years to manifest. Mrs. Pagano said, “All I can tell you and other doctors have said if I didn’t have lupus before the mesh surgery and I got it afterward the mesh had to be implicated.  I have a thyroid issue so every six months my blood was tested.  No one ever found lupus.”

Mrs. Pagano said that “Hopefully telling my story, describing my symptoms, and sharing my progress will help other people suffering to be diagnosed sooner rather than later.  It seems the medical community loves to tell sick people they are crazy!”

To read the full article click here.

Contact a Transvaginal Mesh Attorney

As a consumer and a patient, you have the right to trust your medication is safe. All too often, this is not the case. If you  have suffered a personal injury as a result of a dangerous or defective medical device, you may have grounds for a product liability lawsuit.

At, we are well versed in the product liability laws that protect consumers. Our transvaginal mesh attorneys have handled countless lawsuits involving dangerous medical devices and harmful pharmaceuticals. If you have experienced transvaginal mesh side effects, contact us today and discuss your potential lawsuit with an experienced trial lawyer.


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