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If you have undergone any type of mesh surgical treatment in the last few years, you may be a qualified candidate to undergo lawsuits that are filed against the maker of the product. In this article, we look deeper into the mesh device, how the mesh has wronged patients who have it implanted, symptoms common to the failed medical device, what options are available to victims who are suffering from the mesh implant, as well as how an attorney may be able to help with this frustrating situation.
The said mesh is used as an adhesive to patients who have a hernia poking out of their normal tissue walls. A medical device company called Atrium Medical is the manufacturer of such. These products were developed for use in repair of hernia and similar soft tissues during surgery. Among these other surgical uses for the mesh are surgical wounds, chest wall reconstruction, as well as for traumatic wounds. Atrium's meshes prove to be permanent implants in a patient’s body.
The medical company originally designed these mesh for repairs of inguinal hernias through a medical process known as the IPOM surgical procedure. In this technique, the surgeon places the mesh between the intestine and the hernia wound. Unfortunately, this process often causes risk of an adhesion. Adhesions are known as scar-like tissues. These connect other tissues together, when in fact such tissues should not be connected at all.
Naturally, the medical device company claims that it had no idea that such adhesions would occur within the patients. The company utilizes a fish-oil derivative as a coating for the devices. In addition, Atrium further believed that this fishy oil serves to stop any adhesion and inflammation in the patient.
Keep in mind that this is not a new product, as it now has more than a decade of medical and procedural history behind it. The FDA approved Atrium's mesh back in March of 2006. They fast tracked it along the 510k approval regimen. Moreover, this means that the mesh itself was not made to go through human clinical trials before the maker could sell it.
In such a way, the developer of the mesh saved years of time and expense for such exhaustive clinical trials. The company achieved this by working to the satisfaction of the FDA, given that the mesh possessed a substantial equivalency to other forms of surgical mesh that had already undergone these clinical trials. This means there were not adequate enough procedures done in advance to prove the product was both effective and safe for use in repairing hernias, surgical wounds, traumatic wounds, or chest wall reconstruction. One may argue that this was a disaster waiting to happen, a ticking time bomb for the unfortunate patients who were promised that this was the answer to their issues in the surgery.
The medical company, Atrium, originally intended for their widely used product to be primarily used in surgical hernia repair. Although, in subsequent years the medical industry found other uses for it in repairing similar soft tissues that were badly damaged and required surgery. This included the chest wall reconstruction surgeries, traumatic wound surgeries, as well as surgical wound repair. The mesh either was produced using fibers, or in some instances, using animal flesh (primarily from pigs).
There have been a number of studies performed on the mesh since it appeared on the market more than ten years ago. Some of these studies have suggested that it possesses a greater rate of infection than competing meshes on the market. Patients have pressed the U.S. FDA with reports of complications.
Patients often complained about complications including:
Besides these patient complaints, a large number of doctors have also reported their issues with Atrium's mesh. These medical professionals have insisted that the mesh sticks to the bowels, as well as other places within the human body. Implants of this mesh has increased the dangers of incurring severe internal injuries like gastric ulcers and organ perforation.
A 2009 study first published within the British Journal of Surgery revealed that this particular mesh design (as well as those of competing meshes which were similar in nature and design) did successfully prevent initial adhesion at first. However, this success did not last long at all. Following the first few months of success, the adhesion measures of prevention began to degrade with time.
Another case study from 2016 evaluated a patient, a 61-year old woman. The woman received the mesh implant due to a hernia repair surgery done by incision. In only ten months, she began to complain about severe upper abdomen discomfort and pain. The doctors conducting the study put her through a revision surgery and discovered oozing and thick adhesions surrounding the mesh in her body. As a result of this, the doctors found it necessary to take out both the mesh as well as a portion of her stomach. She suffered from an inflammation because of the mesh with its fish oil coating.
In 2013, the company recalled 145,000 mesh units because of problems with the packaging. The FDA had also issued several warnings about their mesh, as well as a federal injunction against the medical company.
Today, there are more than 21 hernia mesh lawsuits against Atrium's mesh which are pending in the courts of New Hampshire alone. These lawsuits were filed in a few different courts. By 2016, lawyers began a multiple district lawsuit against the company for the mesh cases. As of May 2018, there have been over 471 different mesh lawsuits pending in the multi-district litigation. The original suit will be tried starting February 19th of 2020. The most telling charge in this lawsuit is that the developer and maker were fully aware of the design defects in their mesh products. The parties involved state that they willfully hid such knowledge from the FDA, members of the medical community, as well as from the public. In addition, the medical company failed to deliver the necessary risk warnings to both patients and their doctors.
The easiest way to get involved in one of these lawsuits is to join an already existing class action lawsuit within the court system. If you, or someone you love, decides to file your own or join one of the pre-existing lawsuits, you must retain a highly experienced medical malpractice attorney to help support your unique case. This is more important than ever as such cases all too easily become bogged down under medical records, paperwork, contacts, as well as other obstacles in the legal system.
Attorneys who are knowledgeable in medical malpractice (such as the allegations imposed by Atrium) are passionate about working diligently to defend these severely mistreated and injured patients. The goal of these knowledgeable product liability attorneys is to gain proper compensation for the affected patient’s pain and suffering, all while punishing the company financially that engaged in such reckless, demeaning and profit-driven behavior. For any questions, comments, or concerns you may have regarding your unique situation, contact our firm immediately.
Jack Ter-Saakyan has been a member of the California State Bar since 2009. Mr. Ter-Saakyan strives to provide each client with an informed understanding of the client’s legal rights, obligations, and options. Mr. Ter-Saakyan zealously advocates on behalf of his clients during all stages of his client’s cases.
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