Although Covidien hernia mesh products have been approved by the U.S. Food & Drug Administration (FDA) for use in hernia repair procedures, the FDA has noted hernia surgical mesh devices may be linked with the development of complications.(1)
FDA Notes Hernia Mesh Complications
Covidien hernia mesh complications can be similar to the complications for other FDA-approved hernia mesh devices. According to the FDA, some common complications that can occur with the use of hernia mesh include:
- Hernia recurrence
- Adhesions forming — scar-like tissues that stick tissues together
- Bowel obstruction — blockage of parts of the intestines
Other potential problems that can occur with the use of hernia mesh are:
- Mesh migration
- Mesh shrinkage(2)
Hernia Mesh Events Reported to FDA May Lead to Recalls
When manufacturers of medical devices learn their products may have led or contributed to an adverse event, or may have malfunctioned, they are required by law to report these adverse events to the FDA.(3)
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The FDA also encourages patients, physicians, and others who encounter or experience an adverse event occurring with the use of a particular medical device to report that adverse event to the FDA’s MedWatch.(4) (5)
Sometimes, as the number of adverse events linked to a particular medical device mounts, manufacturers or the FDA may recall that product.(6)
Certain Covidien Parietex Hernia Mesh Devices Linked to Adverse Events
Currently, the FDA MAUDE database includes reports of adverse events for some Covidien Parietex mesh products, such as:
- Covidien Parietex Surgical Mesh
- Covidien Parietex Composite Mesh
- Covidien Parietex ProGrip Mesh
Some of the reports discuss patients who suffered pain, needed additional surgeries, or were hospitalized due to the hernia mesh used in their surgical hernia repair.
Covidien Parietex Surgical Mesh
According to one patient’s adverse event report, their Covidien Parietex surgical mesh failed altogether. That patient reported needing additional surgeries to locate the mesh, which had migrated. A CT scan finally found it at the bottom of the patient’s stomach.(7)
Covidien Parietex Composite Mesh
In another report made in May 2017, a patient needed to have a “panniculectomy because fat necrosis had grown onto the mesh and was hurting.” Not only was the patient hospitalized, it was reported this patient so far had undergone two hernia repair procedures. The adverse event type was “serious injury and the event outcome [was] hospitalization.”(8)
In a separate case, a patient reported they “had hernia repair surgery and [were] implanted with [Parietex] composite mesh.” After the mesh was implanted the patient reported they were “[h]ospitalized once for infection and then had to have the mesh surgically removed after another infection.” (9)
Covidien Parietex ProGrip Mesh
In one instance, an adverse event report discussed a patient who underwent a left inguinal hernia surgical procedure and received a Covidien Parietex ProGrip mesh. Afterward, “the patient experienced increased pain…” In an attempt to alleviate the pain, “the patient had cryo-ablation to [deaden] the nerves…The patient needed to continue to have injections…to help with the pain.”(10)
In another adverse event report, a patient stated they underwent surgery to repair an inguinal hernia. The surgeon used a Covidien Parietex ProGrip mesh. Just weeks after having the surgery, the patient reported they “developed extreme debilitating pain at the surgery site and into the groin area. After many attempts to relieve the pain through pain management, with little to no relief,” the patient “had a second surgery to remove the mesh.” (11)
In addition, in another report a patient underwent a bilateral laparoscopic inguinal hernia repair. According to the patient, “the mesh gave away causing swelling in [the] left groin, passing urine and other medical complications.” The patient underwent a revision surgery, and suffered complications.(12)
Covidien Hernia Mesh Recall
At this time, neither the FDA nor Covidien have issued any Covidien hernia mesh recalls for these models. According to the FDA, a recall is an action a manufacturer or firm takes “to remove a product from the market.” A recall can be handled in one of three ways:(13)
- The manufacturer or firm acts on its “own initiative” to recall a product.
- The FDA requests the manufacturer to recall a product.
- The FDA orders the manufacturer to recall a product “under statutory authority.”
The FDA has designated three classes of recalls based on a product’s potential danger to consumers:(14)
- Class I
- A Class I recall reflects the highest degree of concern for people’s safety. When the FDA designates a recall a Class I recall, “there is a reasonable probability that the use of or exposure to” a particular “product will cause serious adverse health consequences or death.”(15)
- Class II
- A Class II recall is one in which the FDA determines the “use of or exposure to” a particular “product may cause temporary or medically reversible adverse health consequences” or the likelihood of “serious adverse health consequences is remote.”(16)
- Class III
- The FDA classifies a recall a Class III recall when a particular product is “not likely to cause adverse health consequences.”(17)
Covidien Hernia Mesh Attorney
Although some degree of pain and discomfort following a hernia repair surgery is not unusual, severe pain and other disabling complications could be indications of defective surgical mesh.
Did you undergo a revision surgery to correct complications following your initial hernia repair procedure?
Or have you had a conversation with your physician in which he or she recommended a revision or corrective surgical procedure due to extreme complications following your hernia repair surgery?
In either of these instances, if you received a Covidien hernia mesh implant, you may be entitled to pursue compensation from Covidien.
If you are facing this difficult situation, we encourage you to contact an experienced Covidien hernia mesh attorney. A knowledgeable Weitz & Luxenberg attorney would be able to help you determine if you are eligible to pursue legal action.
For more information, we encourage you to contact us. One of our Covidien hernia mesh attorneys would be happy to arrange a free consultation.
With more than two decades of experience handling large-scale litigation involving defective medical devices and drugs, and serving as court appointed lead counsel in multiple medical device litigations, Ellen Relkin is the type of attorney you want working for you.
“Even though there is no official recall for a defective product, it continues to hurt some patients and cause suffering. Certain types of hernia mesh is one such product. If you’ve been harmed, you may have the right to take action against the companies that caused you to suffer that harm,” Relkin says.
She adds, “You need an attorney with significant experience with claims against the manufacturers of defective medical products due to the complexities involved in such cases.”
For decades, Relkin has been leading Weitz & Luxenberg’s Drug and Medical Device Litigation group of attorneys because she knows how to win the tough cases — cases affecting thousands of people harmed by defective drugs and medical devices. She has served as court appointed lead counsel in multiple orthopedic device litigations where she negotiated settlements exceeding five billion dollars.
She is noted for her roles in helping secure victories against the manufacturers of defective medications and devices.
“That’s where my heart is,” Relkin says, “helping our clients get their lives and dignity back. You have a right to be treated with respect and care. And when manufacturers don’t do that, they deserve to be held accountable. Doing my best to help each and every one of our clients is what lets me sleep at night.”
Covidien Hernia Mesh Lawsuit
Weitz & Luxenberg’s Drug and Medical Device Litigation team has begun the steps needed to take legal action against Covidien and other surgical mesh manufacturers. These hernia repair mesh products are linked to extreme medical complications in some cases.
Have you suffered any of the following complications that necessitated a corrective or revision surgery — or has your doctor recommended you undergo a revision surgery because your hernia repair mesh has resulted in any of these complications?
- Bowel obstruction
- Mesh failure
- Device migration
If you experienced complications resulting from your Covidien mesh implant, you may be able to seek compensation for not only your current but also future medical expenses related to the injuries you have suffered. This compensation could also potentially include lost earnings if you were not able to work, as well as other expenses you incurred due to your injuries.
Weitz & Luxenberg Is Here to Help
Our attorneys have prepared and filed lawsuits against a number of manufacturers of hernia mesh products, and anticipate filing Covidien hernia mesh lawsuits. We are representing clients who suffered significant complications, including corrective or revision surgical procedures, linked to certain Covidien hernia mesh implants.
In some instances, physicians have advised their patients to undergo revision surgeries and patients have not yet been able to get the recommended surgical procedure done.
For a free consultation, we invite you to contact us. For your convenience, you may reach us by phone at (833) 544-0604 or complete the form on this page. One of our representatives will contact you shortly.