Caldera vaginal mesh, like other similar implantable mesh products, offered a minimally invasive way for doctors to perform pelvic organ prolapse repair and other similar procedures. However, it became apparent to many women that this type of transvaginal mesh might do more harm than good. In fact, when considered together, the lawsuits surrounding Caldera mesh and other similar polypropylene mesh products represent one of the largest mass torts in the history of the U.S. legal system.
If you believe you suffered complications or you required revision surgery following a procedure utilizing this transvaginal mesh, contact a Caldera Mesh lawsuit lawyer for help. You may be eligible to file a claim for compensation to cover your medical bills, lost wages, pain and suffering, and other damages.
Call the defective medical device team at Gacovino, Lake & Associates, P.C., today. We can evaluate your case, explain the viability of your claim, and help you understand your options for recovery. You can reach us at 800-550-0000 to schedule your complimentary case review.
What Complications Have Women Reported With Caldera Mesh?
Caldera manufactures a polypropylene mesh most commonly used to treat vaginal prolapse and stress urinary incontinence. Like other similar mesh products, though, evidence links transvaginal use to a number of serious complications. Some of these reports include adverse events and side effects, such as:
- Erosion of the mesh;
- Contraction or shrinking of the mesh;
- Infection around the mesh;
- Issues completely removing the mesh, even during surgery;
- Unusual pain or discomfort;
- Pain during vaginal intercourse;
- Scarring in the vagina;
- Recurrence of pelvic organ prolapse; and
- Issues with urination.
Many women who suffer a recurrence of their original symptoms, mesh failure, or serious side effects may require revision surgery to repair or remove the patch. This process is sometimes more difficult than it should be. That is because this mesh can embed itself in nearby tissues. If this occurs, it may take multiple excision surgeries to fully remove it. Occasionally, total removal is impossible.
If you have experienced adverse symptoms after undergoing Caldera mesh surgery, our attorneys can help. We will investigate your case to determine if the medical device manufacturer is to blame for your suffering. If so, we will hold the company accountable for your losses.
Is the Federal Government Concerned About Caldera Mesh or Other Transvaginal Mesh Products?
Prior to its first public health notification related to transvaginal mesh, the U.S. Food & Drug Administration (FDA) received thousands of reports of adverse events stemming from these products. It was, in part, these reports that led the organization to raise concerns about Caldera and other vaginal mesh products in 2008. This initial public health notification addressed the serious complications doctors and patients alike reported after placement of transvaginal surgical mesh during procedures to repair pelvic organ prolapse or stress urinary incontinence.
The FDA followed its initial warning with a 2011 communication, which also came with an in-depth white paper discussing the increased risk of complications associated with transvaginal mesh during pelvic organ prolapse repair procedures. In this white paper, the FDA suggested there is no benefit of using transvaginal mesh during this procedure, and that traditional repair methods offer the same results with fewer complications.
Their current stance on Caldera mesh and similar products is that most pelvic prolapse repair does not require mesh. Instead, doctors should perform a more traditional procedure.
What Is the Current Status of the Caldera Mesh Lawsuits?
Caldera reached a settlement with more than 2,700 women who filed lawsuits against the company in California State Court in Los Angeles. The company’s original offer of $11.75 million received objections from more than 35 of the claimants, but the court later approved a settlement offer of $12.25 million to resolve all pending lawsuits. The deadline to receive compensation from this settlement expired on May 2, 2016.
While Caldera was not a plaintiff in the large multidistrict litigation (MDL) related to transvaginal mesh, there is no doubt the company’s executives and the claimants who filed lawsuits both watched the proceedings closely. With more than 75,000 lawsuits, the U.S. District Court for the Southern District of West Virginia hosted this mass tort under the oversight of Judge Joseph R. Goodwin.
Goodwin presided over the pretrial proceedings and discovery process of the multidistrict litigation, as well as the bellwether trial. Before sending the individual cases back to their original jurisdictions, however, he took the unusual step of urging the seven defendants to settle as many claims as possible at this point. Because of the number of cases involved in the MDL, sending them all back to their jurisdictions for trial could cause a major issue in other courts.
For the most part, the companies involved took his urging seriously. Most of the defendants settled a large number of the pending cases at this juncture. Those awaiting a Caldera settlement or trial at the time no doubt took note of the large, multi-million dollar settlements these mesh manufacturers paid out.
Even though these cases reached a settlement, you may still be able to file a lawsuit or claim to recover compensation based on your experience with Caldera mesh or another transvaginal mesh product. We can help you understand if you have a viable case against one of these medical device manufacturers and we can explain how to pursue compensation. We handle all transvaginal mesh cases on a contingency fee basis, so you do not owe us anything until we recover a payout on your behalf.
Talk to a Caldera Mesh Lawsuit Lawyer at Gacovino, Lake & Associates, P.C., About Your Case Today
At Gacovino, Lake & Associates, P.C., our mass tort attorneys can help you file a claim based on your Caldera mesh complications. We are standing by to review your case, determine the viability of filing a suit, and explain your legal options. We offer free consultations and case evaluations. Call us today at 800-550-0000 to schedule a time to talk with a Caldera mesh lawsuit lawyer about your case.