The Mn Criminal Defense, Personal Injury & Family Law Blog
FDA Approves Hernia Mesh Fix
April 2, 2019
The team behind Amarim’s FasTouch absorbable fixation system hope that this product improvement will make hernia mesh victims a thing of the past. That’s good news for people who undergo this procedure in the future, but it doesn’t help the thousands who have already been injured.
Doctors can use the updated mesh in many procedures. Company CEO Ofek Levin says the new device eliminates the soft tissue fixation problem. “Our data clearly demonstrate that a lockable solution is more reliable in such a dynamic environment and minimizes the risk of tack migration or dislodgement that may lead to complications and hernia recurrences,” he added.
The Hernia Mesh Story
Dangerous hernia meshes have adversely affected tens of thousands of people. These victims must deal with the serious injuries outlined below. Perhaps the real tragedy in all this is that the hernia mesh addresses conditions which are painful, but not very serious and certainly not life-threatening.
When women undergo abdominal or stomach surgery, side effects often include pelvic organ prolapse and stress urinary incontinence. These issues are especially common in older women who have had children. If the patient has POP, the bladder, rectum, uterus and other pelvic organ sag and bulge outside of the vagina. SUI is a similar condition. The increased abdominal pressure causes urine to leak when women laugh, cough, exercise, or otherwise use their abdomens.
Surgical meshes are supposed to fix these problems by supporting pelvic organs. But they often create more problems than they solve. That’s when Brainerd personal injury lawyers step in.
Infection is a serious problem. Typically, antibiotics do not cure these deep infections. Doctors must surgically remove the mesh, which is a very complex process. The mesh material fuses with organic material. Some surgeons say hernia mesh revision surgery is like trying to pull hair out of chewed bubblegum.
Hernia mesh infection is not like other hospital or wound infections. Biofilms, which are some of the stoutest bacteria colonies known to medical science, form around the incision site. Antibiotics ease the symptoms but do not eradicate the infection. Signs of infection include:
Slow incision healing,
Warmth around the incision site, and
If you suffer from these symptoms, contact a Brainerd personal injury lawyer. The problem may be an infected hernia mesh, which means you need specialized treatment and care.
In other cases, your hernia mesh could be defective. If the mesh erodes into body tissues, as outlined above, the victim could develop side-effects like excessive scar tissue, another hernia, or even a dangerous abscess.
Your Claim for Compensation
Legally, manufacturers are strictly liable for the injuries which their defective products cause. Amount of care is irrelevant. So, victim-plaintiffs need only prove causation. There are basically two types of product defects:
Design Defect: Some hernia meshes were defectively designed. The mesh was dense enough to support organs if the patient basically laid in bed, but once the patient resumed limited activities, like walking to the bathroom or enjoying a dinner with family, the mesh was not strong enough.
Manufacturing Defect: In other cases, the surgical mesh may have looked fine on the drawing board. But the manufacturer replaced quality ingredients with cheap substitutes that could not do the job. Generally, the manufacturer is responsible for any defects that occur until the time the mesh is sold.
Brainerd personal injury lawyers can usually obtain significant compensation in these cases. That compensation includes money for economic damages, such as medical bills, and noneconomic damages, such as pain and suffering. Additionally, many jurors award significant punitive damages in defective product cases. Typically, the company intentionally disregarded a known risk.
Procedurally, most hernia mesh and other defective medical device claims go through Multi-District Litigation. MDL is designed for mass tort cases, like defective hernia mesh claims, which would be hard to hear individually but do not have enough in common to qualify as class actions.
Typically, courts consolidate these claims for pretrial purposes. That consolidation gives Brainerd personal injury attorneys the chance to combine their resources with other victims from other parts of the country. Additionally, once one case settles, the dominoes usually keep falling, so a favorable out-of-court settlement is a real possibility. The case usually goes back to its home jurisdiction for trial, if necessary.
What the Product Update Means to Brainerd Personal Injury Lawyers
Product updates are a thorny issue in defective product claims. They often convince jurors that the underlying product was defective, but their admissibility is limited under Federal Rule 407. To get around this limitation, most Brainerd personal injury lawyers argue that the subsequent remedial measure just establishes a product improvement. A 2020 Toyota is an improvement over a 2010 Toyota, but the 2010 Toyota was not defective.
On a somewhat related note, the short two-year statute of limitations may be a problem as well. Sometimes, hernia mesh injuries are invisible for quite some time, and when things like pain appear, doctors explain it away as something else. If the statute of limitation has already expired, you could still file a claim for damages. An experienced Brainerd personal injury lawyer can fill you in on the details.