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Surgically implanted hernia mesh devices have been plagued by defects and higher-than-expected side effects.
Hernia mesh is not the silver bullet for hernias that patients and doctors once believed it to be. In the last few decades, it has emerged that these synthetic devices create many medical problems and complications for patients ranging from bleeding to internal organ perforations over time.
Hernia treatment has become an increasingly common surgery in the United States over the years. Nowadays over a million individual hernia repair surgeries occur within the U.S. Around 800,000 of these surgeries repair inguinal hernias while the remainder repair other kinds of hernias.
Many surgeons will advise first engaging in what they call "watchful waiting." This treatment that is not a treatment involves watching the hernia closely to ensure it is not growing larger or creating problems for the patient. The fact is that surgery remains the only form of effective treatment that repairs hernias. This choice allows patients who do not complain from hernia-related symptoms or complications to see if the hernia condition is stable so that surgery is not necessary.
Two primary forms of surgical treatment exist for hernias. These areLaparoscopicandOpen Repair. With Laparoscopic, surgeons start by creating a few tiny incisions in the patient's abdomen, allowing the surgeon's tools to reach inside the incisions so that he can repair the hernia in question. Laparoscopic surgery does not require the use of surgical mesh to perform it, though it can be utilized if so desired.
With Open Repair surgery, the doctor creates an incision close to the hernia. He then repairs the weakened muscle areas. Such Open Repair can also be performed either with or without using surgical mesh. Some Open Repair makes use of sutures but no mesh. They call this primary closure. For infants, people with smaller hernias, infected hernias, or strangulated hernias, this method of primary closure is preferred.
Such hernias commonly recur. Because of this, surgeons will often elect to employ surgical mesh to strengthen this hernia repair so they can decrease the chances of them recurring. From the 1980s, a marked increase in mesh-based repair of hernias because noted. By the year 2000, non-mesh surgeries made up fewer than 10 percent of all groin hernia repairs.
Besides the stronger repairs, such surgical mesh will also boost the patient results with shorter operating time and more comfortable recovery times. Patients should be aware though that recovery is also a function of the kind of hernia, the condition of the patient before and following the surgery, and the surgical approach employed.
Medical literature information conclusively finds that hernia recurrence through the use of surgical mesh is significantly reduced versus such repair that does not employ surgical mesh. As an example, inguinal hernia recurrence becomes higher following open repair utilizing sutures in primary closure than that repaired with mesh.
Some situations arise where using mesh for hernia repair is not recommended. It is always wise to discuss the best techniques with the surgeon regarding the patient's circumstances and particular hernia situation.
The surgical mesh itself is a medical device. The mesh has become popular in giving greater support to damaged and weakened tissue. Most of these devices on the market today were built from either animal tissues or synthetic materials.
Synthetically engineered mesh comes in two forms. These are knitted mesh and non-knitted sheet-like structures. The synthetic materials have the advantages of being available with a variety of properties. These can be absorbable, non-absorbable, or both types of materials.
For those mesh constructed from animal tissues, they generally come from skin or intestine. These will have been disinfected and processed, so they are suitable to be implanted in humans. The advantage to the animal-based mesh is that they are all absorbable. Most organic mesh comes from tissues of either cows or pigs as their source.
With mesh that is non-absorbable, it is intended and designed to stay within the human body forever as a permanent medical implant. This mesh effectively reinforces the repaired hernia permanently. Absorbable mesh, on the other hand, will gradually deteriorate and diminish in strength with time. That is why it is never intended to deliver longer-term reinforcement to the site of hernia repair. When the material naturally degrades, the body is supposed to produce new growth tissue to strengthen the repaired place naturally.
The FDA has done extensive analysis of medical hernia mesh devices to determine their safety for continuing use in humans. Their review of both scientific publications and adverse event reports have helped them to understand the complications of surgically repaired hernias. These include all of the following:
Some of these negative effects have proven to be more common and severe than others. The most common negative impacts of hernia repair surgery using mesh include the following:
Besides these, additional possibly severe events that happen after the hernia mesh repair surgery include mesh contraction (or shrinkage) and mesh migration.
A great number of these complications that result from surgical mesh hernia repair have been shared with the FDA. Many of them were connected with mesh products that were subsequently recalled and are no longer offered for sale. Recalled mesh device symptoms most commonly reported to the FDA include the following negative side effects:
In the analysis of negative reports made to the FDA, they found that such recalled hernia mesh products proved to be the primary contributor to bowel obstruction and perforation complications.
Hernia mesh lawsuits arose because of the adverse side effects that resulted from implanting them in unsuspecting patients. These surgical procedures were intended to stabilize abdominal tissues following hernia repair surgery. Since roughly 90 percent of all hernia repairs performed annually (800,00 per year in the U.S. alone), many thousands of hernia mesh patients have suffered terrible side effects and complications.
There are several major Hernia mesh manufacturers in the U.S. The three who are most facing lawsuits for the failure and complications caused by their hernia mesh products include Atrium Medical, C.R. Bard, and Ethicon (a division of Johnson and Johnson). The three companies now face a combined over 50,000 individual lawsuits for these medical devices which have caused severe internal injuries.
The source of these surgical hernia mesh medical devices is either synthetic polypropylene materials or natural ones derived from animals. The materials have much in common with other kinds of surgical repairing products like bladder sling devices and transvaginal mesh that have led to thousands of lawsuits for medical injuries over past years.
Lawsuits for hernia mesh devices center on sometimes severe side effects, including the following:
In a significant number of the hernia mesh implanted devices scenarios, such complications and adverse side effects have been severe enough to force patients to undergo more surgery to take out the medically defective devices, reconstruct damaged tissues, and repair the original hernia. Such extra operations involve pain and risk to the patients and all too often considerable recovery times as well.
The manufacturers of hernia mesh intended that it would decrease complications associated with hernia repair as well as improve the success rates for these repair surgeries. It was more than five decades ago that such synthetic surgical mesh first saw its use in medicine. It only became widespread back in the late 1980s and early 1990s.
But by the year 2000, a range of reports trickled in, with rumors emerging of severe complications with the devices and procedures. Despite this fact, the employment of such surgical mesh has only become more widespread and popular in thehernia revision surgery. Today sees approximately 90 percent of hernia repair surgeries completed with the use of a surgical mesh medical device implanted in the patient. The FDA continues to add to its own hernia mesh recall list and to issuedefective hernia mesh recallsfrom time to time.
Hernia mesh medical devices have easily caused as many problems as they have solved. They became heavily used from the late '80s through the early '90s and have only gained more significant market share since then. Thousands of cases of severe complications from the use of them in patients have led to as many as 50,000 individual lawsuits against the big three manufacturers of medical hernia mesh devices. The FDA created a hernia mesh recall list as reports of severe complications poured in over the years. Defective hernia mesh recalls have not stopped still more surgical complications and lawsuits though.