Boston Scientific Mesh Lawsuits

Did your doctor diagnose you with mesh complications like bowel perforation, mesh erosion, or mesh failure from a Boston Scientific mesh implant?  Don’t suffer in silence. The attorneys at Baron & Budd are fierce advocates for victims injured from mesh complications. Call our law firm to discuss your case with a member of our team, and determine your eligibility to file a lawsuit for mesh problems against Boston Scientific.

Boston Scientific manufactures a large number of medical devices. On its website, it portrays its mission as being “dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.”

Nowhere on its website does it mention the thousands of lawsuits that have been filed against it by women who were injured by its Pinnacle Pelvic Floor Repair Kit (Pinnacle).

The company does not refer to the millions and millions of dollars it has paid to settle just a fraction of those lawsuits, nor does it mention that thousands are still pending resolution.

Also left out of Boston Scientific’s self-praise is the fact that despite its voluntary recall of the product in May 2011, and its massive payout to settle a few lawsuits in 2015, there are new lawsuits still being filed.

Boston Scientific was the first manufacturer of transvaginal mesh with its ProGen product, which it recalled in 1999. Even so, the ProGen was used as a model by other manufacturers before they, too, had to recall their vaginal mesh products.

In 2004, the company introduced to the worldwide market its Pinnacle Pelvic Floor Repair Kit. Thousands of women suffered from complications of the Pinnacle mesh implant, and it was finally recalled in 2011.

Pinnacle Mesh Recall, Pelvic Floor Repair Kit

In 2011, Boston Scientific voluntarily issued a Class II recall of its Pinnacle mesh.   A Class II recall means the use or exposure to the product “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

The thousands of women who were injured by the implant of the mesh would likely disagree with this recall definition since they suffered irreversible and serious adverse health consequences.

Serious Complications from Boston Scientific Brand Mesh

The most serious complications from Boston Scientific ProGen mesh and Pinnacle mesh models that were recalled are organ perforation and erosion. The most problematic vaginal mesh products manufactured by Boston Scientific and its subsidiaries include:

  •   Pinnacle Pelvic Floor Repair Kit
  •   Transobturator Tape (TOT)
  •   Transvaginal Tape (TVTO)
  •   Obtryx Transobtuator Urethral Sling System
  •   Prefyx PPS Sling System
  •   Uphold LITE Vaginal Support System Sling

What is Mesh Erosion?

Mesh erosion occurs when the mesh wears through the vaginal wall. It can even protrude through the vagina to a degree that it becomes  visible. This makes intercourse extremely painful and sometimes impossible. Erosion can lead to frequent urinary tract infections and to incontinence, a condition for which the mesh was installed in the first place. Often times removal is one’s best chance at eliminating the pain. Unfortunately,  mesh removal is not always successful, and can require several operations. The removal of an eroded mesh has been likened to “cutting gum out of hair.”

How Can Vaginal Mesh Perforate Organs?

The erosion of the vaginal mesh can lead to organ perforation when small pieces of eroded mesh break off and become lodged, puncturing surrounding organs. The organs most commonly penetrated by mesh migration are the bladder, bowel, rectum and urethra. A perforated bowel or bladder can leak contents into the bloodstream, causing serious infection, even sepsis. Sepsis is a serious infection of the blood that can be fatal.

There are also a number of other serious complications that can occur from mesh vaginal mesh implants.

  • Nerve damage.
  • Fistulas.
  • Sepsis.
  • Organ perforation.
  • Vaginal scarring.
  • Degradation of the mesh.
  • Painful mesh shrinkage.
  • Infections, most commonly of the urinary tract.
  • Autoimmune disorders leading to rejection of the mesh.
  • Recurrence of the prolapse which led to the original need for surgery.
  • Organ Removal.

Symptoms of a Serious Mesh Implant Complication

If a woman experiences any of these symptoms, she should consult her doctor to determine if she is suffering from a serious complication from her vaginal mesh implant.

  • Severe pain in the groin area.
  • Bleeding from the urinary tract.
  • Vaginal bleeding.
  • Blood in the stool.
  • Vaginal or abdominal pain.
  • Fever.
  • Mesh erosion or protrusion.
  • Mailaise.
  • Painful or impossible intercourse.

When the mesh has begun to protrude through the vagina, but is not yet visible, intercourse is painful for both the man and the woman.

Boston Scientific Mesh Settlements and Lawsuits

By March 2014, 16,700 transvaginal mesh lawsuits were pending against Boston Scientific. Allegations are that the company knew the product was defective but continued to market it anyway. It failed to warn about the dangers of the product.

In 2015, the company paid $119 million to settle approximately 3,000 of the lawsuits. Many more lawsuits have been filed since that time. As of June 2016, thousands of lawsuits were still unsettled.

Contact an Attorney Who is Experienced with Vaginal Mesh Litigation

If you had a transvaginal mesh implant and are experiencing any symptoms of serious complications, contact the attorneys at Baron & Budd. We have the experience and expertise you need on your side. We offer a free case evaluation so we can review your potential case and see if you’re eligible to file a claim. Call now to speak with a member of our firm about filing a vaginal mesh lawsuit.

Sources

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100416

http://www.fda.gov/downloads/Training/CDRHLearn/UCM2092 81.pdf

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/RecallsCorrectionsAndRemovals/