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Apparently, the manufacturer of Gore Tex believes that it is a versatile product because it also uses the material to make an implantable hernia mesh. W.L. Gore & Associates has been selling products made out of the material since 1969. The product is made out of a material called polytetrafluoroethylene. We know this product by […] 
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Hernia repair is known to be one of the commonly practiced surgical methods. Even surgeons know well that this is one of the most common operations that occur in hospitals. Due to the commonness of the procedure, various types of operations have been offered in many hospitals around the world as long as hernia repair …
David Slepkow's insight:
Hernia repair is known to be one of the commonly practiced surgical methods. Even surgeons know well that this is one of the most common operations that occur in hospitals. Due to the commonness of the procedure, various types of operations have been offered in many hospitals around the world as long as hernia repair is concerned. There are procedures such as open and laparoscopic treatments for those who wish to undergo this type of surgery. However, the type of surgery that can be done to patients will depend on the recurrence rate after the said operation. The different causes of the recurrence can be identified by experts in order to find the best solutions needed to treat it. Prevention and elimination can be done for the sake of resolving hernia recurrence. Various studies and articles that are worth 40 years have been analyzed for the sake of improving the research when it comes to recurrence treatment to ensure a better condition on a patient’s hernia As a result, the causes of recurrence have been analyzed based on the results of the surgeries done for hernia mesh repair. The success rate of the hernia repair is often observed depending on the operation if it can provide a permanent result if complications will lessen, the timeframe needed for the patient to rest before they can resume their normal activities, as well as the minimal costs of the surgery. But despite all these factors, doctors often view the risk of recurrence as the primary factor when viewing the success rate of hernia repair. A 15% recurrence rate using primary hernia repair was often done before applying the hernia mesh. But despite the usage of the very versatile mesh implants, recurrence rates on the hernia still tend to exist. The main factors vary upon the type of repair done. Gladly, hernia mesh was used and being developed to ensure a better recurrence rate for patients and surgeons. These meshes are often made with a porous material that allows the growth of damaged tissues. The material is also known to be reactive in order to promote ingrowth within the tissue while preventing any type of negative reaction such as inflammation and allergies. The mesh is also known to be durable enough to provide full protection to the groin, and it lessens the risk of recurrence further. FACTORS IN HERNIA REPAIR THAT AFFECTS RECURRENCE RATESDuring an open repair, early recurrences occur due to the issues have done during the operational processes that are done to the patient. This also includes postoperative infections that are considered as the most common cause of the recurrence after operation. There are late recurrences that may occur to the patient such as the defect of the patient’s collagen. Age can also be a leading factor towards the recurrence of a hernia, wherein older patients may experience it often. Medical morbidities are also observed oftentimes in order to determine hernia recurrence as well. On the other hand, laparoscopic repair can decide the risk of hernia recurrence as well. But there are fewer factors that may cause the condition to happen. Mesh placement is the most common cause that may happen after the repair. Other problems include dissection and fixation, and these are often observed in order to view if it’s causing the hernia recurrence. These can also happen as either early or late recurrence to the patient. That’s why numerous researches in regards with hernia mesh usage for hernia recurrence were developed in a way where the researchers often base previous hernia repairs, as well as the numerous articles made by experts to ensure full knowledge and development over the surgery’s improvement. This is also done for the sake of understanding hernia surgery in all aspects, which also include the problems that it may cause. RECURRENCE STATISTICSAn article from Science Direct states that surveys were conducted for the sake of observing recurrence incidents following a hernia repair to a patient. The surveys showed that specialized hospitals and other centers tend to have a recurrence rate of 1%, while general hospitals got a result of 30%. This is great news to the field of medicine when it comes to the usage of mesh. The article also states that 10 – 30% recurrence rates are present during the time when mesh wasn’t introduced to hospitals. What’s alarming was the 35% recurrent hernia repairs to the patients as well. This just shows how extremely important a hernia mesh treatment is needed nowadays if a patient wishes to attain a higher success rate for their surgery. This is a right that all patients must have, and this must be promoted further in hospitals for the sake of decreasing recurrence rates, which can be a huge problem to most patients especially when it comes to their time and finances. REFERENCES: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1190751/ https://www.sciencedirect.com/science/article/pii/S1743919113000873
ALL RIGHTS RESERVED © 2018 · HERNIA MESH ATTORNEY · E&OE ATTORNEY DAVID SLEPKOW AT SLEPKOW SLEPKOW & ASSOCIATES INC., ESTABLISHED IN 1932, IS RESPONSIBLE FOR THE CONTENT OF THIS WEBSITE. SS &A’ S PRINCIPAL OFFICE IS LOCATED AT: 1481 WAMPANOAG TRAIL EAST PROVIDENCE RI. CLIENTS WILL BE NOT ACCEPTED IN THOSE STATES IN WHICH STATE BAR RULES DO NOT ALLOW. DAVID IS LICENSED TO PRACTICE LAW IN RHODE ISLAND AND PROVIDENCE PLANTATIONS, THE COMMONWEALTH OF MASSACHUSETTS AND THE UNITED STATES SUPREME COURT. DAVID SLEPKOW WAS A LONGTIME MEMBER OF THE FEDERAL COURT FIRST CIRCUIT DISTRICT OF RI. THE HIRING OF AN LICENSED ATTORNEY IS A VERY CRUCIAL DECISION FOR A CLIENT. THIS IMPORTANT DECISION SHOULD NOT BE SOLELY MADE BASED ON ADVERTISING OR ON A WEBSITE. THIS WEBSITE IS NOT INTENDED TO BE AN ADVERTISEMENT OR SOLICITATION. INFORMATION, ARTICLES, CONTENT AND OPINIONS ON THIS WEBSITE AND BLOG IS FOR GENERAL INFORMATION ONLY AND DOES NOT CONSTITUTE LEGAL ADVICE OR SOLICITATION OF LEGAL SERVICES. INFORMATION FROM THIS SITE OR IT’S TRANSMISSION IS NOT INTENDED TO CREATE AN ATTORNEY CLIENT RELATIONSHIP. THE RECEIPT OF SUCH HERNIA MESH INFORMATION DOES NOT CONSTITUTE, AN ATTORNEY-CLIENT RELATIONSHIP BETWEEN SLEPKOW SLEPKOW & ASSOCIATES INC. AND THE READER OR VISITOR. IN THE EVENT THAT ANY INFORMATION ON THIS WEBSITE DOES NOT FULLY CONFORM TO REGULATIONS, LAWS OR CASE LAW IN ANY JURISDICTION, THIS LAW FIRM WILL NOT ACCEPT SUCH CLIENTS.. IN CERTAIN STATES THIS HERNIA MESH ATTORNEY BLOG MAY BE DEEMED ATTORNEY ADVERTISING. WE AT SLEPKOW SLEPKOW ASSOCIATE’S INC..HAVE MADE EVERY EFFORT TO COMPLY WITH ALL ADVERTISING LAWS AND RULES. THE RHODE ISLAND SUPREME COURT LICENSES ALL LAWYERS AND ATTORNEYS IN THE GENERAL PRACTICE OF LAW, BUT DOES NOT LICENSE OR CERTIFY ANY LAWYER / ATTORNEY AS AN EXPERT OR SPECIALIST IN ANY FIELD OF PRACTICE. WHILE THIS FIRM MAINTAINS JOINT RESPONSIBILITY, MOST CASES OF THIS TYPE ARE REFERRED TO OTHER ATTORNEYS FOR PRINCIPLE RESPONSIBILITY
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Apparently, the manufacturer of Gore Tex believes that it is a versatile product because it also uses the material to make an implantable hernia mesh. W.L. Gore & Associates has been selling products made out of the material since 1969. The product is made out of a material called polytetrafluoroethylene. We know this product by its more well-known name of teflon.
Many people who have either served in the military or spend time outdoors have heard of the brand Gore-Tex. The company is famous for its waterproof and windproof clothing. The company even makes boots out of the material.
W.L. GORE’S LINE OF HERNIA MESH PRODUCTS
While it is seemingly inconceivable that a product that is used to make boots can be implanted inside the body. W.L. Gore has built an entire medical products division out of products made out of Gore-Tex. Not only does it sell hernia mesh, but it also makes various surgical patches. W.L. Gore sells products such as:
W.L. Gore hernia mesh products are dual surface products. The company claims to design the hernia mesh with two different surfaces. One side is to encourage tissue integration, while the surface of the other side is to minimize tissue attachment. In other words, the hernia mesh aims to repair the hernia without getting completely tangled up in the surrounding tissue.
GORE TEX HERNIA MESH
However, the design also may increase the likelihood that the mesh migrates out of place. The dual surface design could potentially cause the mesh to shift out of position and impact surrounding organs or the bowel. Many of the injuries reported to the FDA have been consistent with mesh migration.
W.L. Gore is not one of the three largest makers of hernia mesh. The company does not release its sales figures because it is a privately-held company. However, its sales are lower than Ethicon, Atrium C-Cor and C.R. Bard. W.L. Gore also entered the ill-fated pelvic organ prolapse mesh market, but its product, along with those from all other device makers, was pulled from the market after women suffered serious side effects. W.L. Gore has faced numerous lawsuits relating to its pelvic organ prolapse mesh.
THERE WAS NO FDA TESTING OF W.L. GORE HERNIA MESH
In 2017, W.L. Gore received FDA approval to sell a Biomaterial hernia repair device. While the name makes these products sound safer, the reality is that many of the reports of adverse events filed with the FDA have involved the Biomaterial hernia repair device.
BIO-A HERNIA MESH LAWSUIT
W.L. Gore’s hernia mesh was approved by the FDA without any testing whatsoever. The FDA allowed W.L. Gore to start selling hernia mesh through a process called the 510(k) process. When a product is substantially similar to another product that is already on the market and has been approved, the FDA allows a device maker to sell after they have notified the FDA. This is how many different hernia mesh products have been permitted to hit the market.
W.L. GORE HERNIA MESH ADVERSE EVENT REPORTS TO THE FDA
Patients are encouraged to report to the FDA when they have experienced an adverse event with a medical device. Their reports are found in the FDA’s MAUDE database and are publicly available. A recent search of the MAUDE database shows that adverse event reports are still coming in at a steady pace.
DUAL MESH
Many of the adverse event reports in MAUDE detail situations in which the Dual Pro mesh was explanted. This means that the patient needed surgery to remove the mesh because it was causing serious side effects. A review of the adverse event reports reveals that many of these patients were suffering life threatening complications that required one or more surgeries to address.
SIDE EFFECTS OF GORE-TEX HERNIA MESH
Some patients reported that the hernia mesh was causing bowel obstruction. This is when hernia mesh can turn fatal. Many patients reported that the Gore mesh was causing serious infections, while some patients suffered from a fistula. In all of these events, the patient was in significant discomfort and pain before the surgery with dramatic side effects. Specifically, these are the type of complications associated with Gore-Tex hernia mesh:
When a patient has these kinds of side effects, they often cannot receive a new hernia mesh. However, they are still left with a hernia that needs repair. Some patients are never able to get the hernia fixed. Not only do they have continued medical issues from the damage caused by the mesh, but they also have a hernia which may never be repaired. These patients will experience a lifetime of discomfort.
THE FDA HAS DONE NOTHING ABOUT THE REPORTS OF SIDE EFFECTS
However, even with the increasing number of adverse event reports, the FDA has not gotten involved and ordered the recall of any Gore products. The company still continues to sell its hernia mesh even though more patients are reporting serious injuries. The side effects from Gore hernia mesh are quite severe compared to the discomfort that many people suffer.
Some damages that people suffer when they sustain long-term injury from hernia meshes such as Gore include:
YOU CAN FILE A HERNIA MESH LAWSUIT FOR GORE-TEX HERNIA MESH
Hernia mesh makers such as W.L. Gore may be sued for manufacturing a defective product that causes injury to patients. You would need to file a product liability lawsuit against the company to allege that the product was defectively designed or manufactured or that the company knew of the dangers of the product and failed to warn you.
A hernia mesh lawyer could help you file your case. Hernia mesh makers have vigorously fought these cases in court and have not yet settled these claims. However, some of the first hernia mesh cases are set to go to trial in 2020, and it will give plaintiffs a picture as to the company’s liability.
If you have been harmed by Gore-Tex hernia mesh, you can schedule a free consultation to learn of your legal rights and your ability to file a lawsuit.