Coloplast Mesh Lawsuit: Recalls, Complications, Erosion

Are you suffering the devastating consequences of mesh removal surgery, erosion, or organ perforation from a Coloplast mesh product? Baron & Budd is currently seeking victims injured from transvaginal mesh complications. Call 866-829-0176 now to see if you qualify for a Coloplast mesh lawsuit.

Coloplast is a manufacturer and supplier of many different products, including transvaginal mesh used in pelvic organ prolapse (POP) surgical repair. The company has world headquarters in Denmark with a U.S. headquarters in Minneapolis. Coloplast is just one of many manufacturers of mesh products used for POP and stress urinary incontinence (SUI) that were sued by women who suffered from serious complications from the use and exposure to the mesh products.

Serious Coloplast Mesh Complications

In 2008 the FDA issued its initial warning to healthcare providers and patients regarding rare but serious complications when surgical mesh is used to repair pelvic organ prolapse (POP) and urinary incontinence.  Complications reported by the FDA that were previously unknown include:

  •   Mesh Erosion
  •   Mesh Contraction
  •   Shrinkage
  •   Organ Perforation
  •   Bowel Perforation & Rupture
  •   Bladder Perforation & Rupture
  •   Infection
  •   Blood Vessel Perforation
  •   Sepsis
  •   Permanent Damage from Mesh Removal

In 2011 the FDA issued an updated warning that complications are NOT uncommon  when synthetic surgical mesh is implanted through the vagina. When surgical mesh is inserted through the vagina during POP repair surgery, it is called transvaginal mesh.

Coloplast Mesh Products with Known Problems

Problematic Coloplast mesh models with complaints of serious side effects include

  • Aris Sling System
  • ArisMD
  • Aris Transobturator Tape
  • Restorelle
  • Supris Suprapubic Urethral Sling
  • Novasilk

What is Mesh Erosion?

Mesh erosion, also called protrusion, extrusion or exposure, is the most common and most serious complication of transvaginal mesh used for POP and SOI repair. When mesh erodes, part of the implant can protrude through the vagina while the other side of the mesh is fused into your organ tissue. Mesh erosion is a very painful and dangerous complication.

Additionally, eroded mesh may break away and travel through the tissues. If this happens, the only solution is to remove the mesh, which may require several operations and, even then, it may be impossible to remove all of the mesh. Mesh removal typically requires several surgeries and is likely to result in organ removal, permanent damage, and will have devastating effects on the quality of the patient’s life.

How is Mesh Contraction and Shrinkage Dangerous?

When vaginal mesh contracts or shrinks, the patient usually experiences vaginal shortening or tightening, bleeding, and severe vaginal pain. The pain can be unbearable and compromise the quality of the patient’s life.

How Can Mesh Perforate Organs?

When a vaginal mesh implant erodes, the pieces of mesh that break away can travel to other organs and puncture them. Pieces of mesh can also impale blood vessels, causing internal bleeding.

Organs most often perforated by eroded mesh migration include the bladder, rectum, bowel or urethra. Punctures in any of these eliminatory organs can cause an internal infection.  An infection from a punctured bowel can rapidly transform into sepsis if waste from the bowels gets into the bloodstream. Sepsis can kill quickly.

Watch Out for Symptoms of Complications

Symptoms associated with Coloplast and other transvaginal mesh problems include, but of course are not limited to:

  • Fever and malaise indicating an infection. This needs to be checked out quickly. Sepsis, a life-threatening infection, begins with symptoms of an infection, including a fever. If not promptly treated, sepsis can lead quickly to death.
  • Severe pelvic pain.
  • Painful intercourse. If the mesh is eroding and exposed,  in addition to the woman suffering severe pain, a man’s penis may be painfully injured during intercourse.
  • Vaginal discharge.
  • Incontinence.
  • Nerve damage.
  • Autoimmune disorders.
  • Sepsis.
  • Death.

These are only a few of the symptoms associated with complications from mesh implants for POP treatment. If you have a transvaginal mesh implant and experience any or all of these symptoms, contact your doctor right away. These symptoms may signal one of the dangerous side effects that are not uncommon with several Coloplast mesh models.

Coloplast Mesh Settlements and Lawsuits

Hundreds of Coloplast mesh lawsuits have been filed against for its defective product design, failure to properly test mesh products before putting them on the market, and for failure to warn about the potential dangers of the use of its product.

In March 2014, Coloplast settled 400 lawsuits for $16 million. When divided, it came to about $40,000 for each plaintiff. The company made it clear that even though it had engaged in settlements, it was not willing to admit that the products were flawed or unsafe.  

The settlement agreement contained a very unusual provision prohibiting the plaintiffs from revealing any details about the settlement.

In addition to paying the $16 million, the company set aside another $186 million for future litigation in anticipation that more women would be filing lawsuits. In September 2015, Coloplast increased its set-aside amount to $457 million.

Coloplast issued a statement after the 2014 settlement that the company was not going to disclose any more details regarding the number of pending claims in the future. However, a publicly available transcription of a conversation between Lars Rasmussen, the CEO of Coloplast, and a mediator, it is clear that litigation is ongoing.

It is still known that Coloplast must deal with at least 1200 more lawsuits that have been filed in federal court and an unknown number in state courts. Plus, its woes are not over. Complications of mesh may not appear for several years after the implant, so it is almost inevitable that there are still more lawsuits yet to come.

Consult with an Experienced Attorney

If you suffer complications after a transvaginal Coloplast mesh implant, contact the mesh lawsuit attorneys at Baron & Budd for a free case evaluation.  A member of our team will discuss your case and determine whether you qualify to file a claim. There are strict time limits for filing a lawsuit and statute of limitations laws unique to product liability cases that vary by state. Don’t let time run and lose your opportunity to file a claim. Call 866-829-0176 today.

 

Sources

https://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf

https://www.coloplast.com/Documents/Provision%20and%20Financial%20Guidance_transcript.pdf