Frequently Asked Hernia Mesh Questions
Hernia repairs are often done by implanting a mesh product in the body. Several specific products used in hernia repair surgeries are now under intense scrutiny due to side effects and complications occurring with patients.
There is a possibility that you or a loved one could be entitled to the recovery of damages if you or the loved one has experienced a failure or malfunctioning of the device, infections, damage to internal organs, or an allergic reaction after having a hernia mesh product implanted. Contact one of our dedicated product liability lawyers at our experienced law firm to discuss your case and review whether you have the right to a claim. Do not hesitate to call us today. Contact Krause & Kinsman to begin the process by scheduling your free consultation.
If you have had a hernia repair surgery, you likely are well aware of the symptoms and description of a hernia; however, for those that may not be as well informed, a hernia happens when the lining or organ protrudes through the layer of muscles in the stomach creating a bulge. Several kinds of hernias exist:
- A hernia that occurs in the wall of the abdomen, known as a ventral or abdominal hernia
- A hernia that happens within a surgical incision site from a prior operation or injury, called an incisional hernia
- Hernias that happen around the area of the groin are known as inguinal hernias
- A hernia that happens at or in the surrounding area of the navel is known as an umbilical hernia
- A hernia that erupts where the stomach and esophagus meet is known as a hiatal hernia
There are multiple ways in which a hernia can be repaired surgically, for example, a biologic graft, sutures, or a synthetic mesh can be used. A variety of devices have come on the scene over the past few years. Manufacturing companies like Gore Medical, Ethicon, and Davol have all produced variation of devices intended for the repair of hernias.
Typically, there are two groups, biologic and synthetic, that divide repair products used for hernias. Biologics are implants made from human tissue, skin from cadavers, pig skin. Synthetic refers to implants that are made for man-made substances, like composites, polyester filaments, polyprolylene, or ePTFE membrane.
Just like any other surgical procedure, a hernia surgery is not guaranteed to repair the problem; however, if the device implanted within you has malfunctioned and resulted in an injury, you could potentially have a claim for product liability against the manufacturer.
Like with any medical procedure, it is imperative to understand what exact device was implanted in you during your surgery, especially which specific device was used in your hernia repair while examining whether you have a case. Call the office of the physician that did your surgery or the hospital where your procedure was performed to obtain documentation from the medical records department. Be sure to obtain and record the documentation of the product number identifying your specific mesh or patch. The reason you will need the product identification number is to identify the product and to be aware of whether the Food and Drug Administration has issued or recalled your product as being defective. You will need to know which product you have so as to know whether it has been recalled or labeled as defective.
After establishing which device was implanted within you, it is critical to have a physician examine your injuries and determine them to be injuries caused by the defect. It will be an important part of the claim process to have your injuries documented and recorded with by a doctor. The most important phase in the determination of whether you have a claim is to show conclusive evidence that the injuries from which you are suffering were caused directly or indirectly by the defective product.
The following problems have been reported by patients with hernia mesh implants:
- Abdominal ulcers
- Obstruction of the bowels
- Perforation of internal organs
- Renal failure
- Failure and/or erosion of the product
- Allergic reactions; and
- Fistulas in the intestines
Several types of mesh products are manufactured for the purpose of hernia repair; however, there are specific mesh products that create serious hazards for patients, like the following:
- Atrium C-Qur™
The manufacturing of this device was stopped permanently shortly after the FDA delivered a ruling that demanded the halting of production.
- Bard Ventralex™ ST
C.R. Bard, Inc. has had reports of several side effects and problematic reactions with the polyprylene mesh product produced for hernia repair. The transvaginal mesh had FDA issued warnings attached, yet the hernia repair product has none at this time.
- Ethicon Physiomesh®
After several studies produced results showing that the use of Physiomesh had a higher than average percentage of the reoccurrence of hernias, the product was voluntarily removed from the consumer market.
Lawsuits involving Physiomesh
Currently, there exists three different cases against Physiomesh in the U.S. Federal Court. The product produced by Ethicon, Physiomesh, has been taken off the market. Ethicon claims that they did not have the product recalled, but rather that in May, 2016, the polypropylene mesh device was withdrawn. Studies done independently produced results verifying that there were a higher than normal rate of complications with the Physiomesh implants. Physicians and consumers had similarly spoken out against the poor quality of the Ethicon-produced device; however, this did not provide enough for Ethicon to determine they had manufactured a poor product design. The reason that most likely explains this is that Ethicon was unwilling to affect the profits derived from the sale of the product. Before the removal of Physiomesh from the market, Physiomesh Open was produced. The 510(k) application was completed in the middle of the year, 2014, and got approved later the same year.
Ethicon, a subsidiary company of the larger, Johnson & Johnson, was hit with multiple lawsuits for Physiomesh, which was intended to be for the repairing of hernias. Physiomesh is manufactured from the very material compound utilized in the transvaginal mesh, another product surrounded by claims and lawsuits. The material, polypropylene, has had multiple complaints as being a hazardous product; however, Ethicon denied this adamantly. That being said, Ethicon still allegedly decided to take the product off the consumer market in the Spring of 2016.
Physiomesh and the FDA
In the Spring of 2010, the FDA provided the initial approval, which was done by Ethicon filing within the 501(k) process for approval. By using this process for approval, Ethicon pushed the product through without the rigorous studies that would typically be used on a product before making its way to the consumer market. Physiomesh was claimed by Ethicon to be a mirror product to their previous product, Proceed. By the June of 2014, a variation of Physiomesh was handed to the FDA via the filing or the product through the 501(k) approval process. Given FDA approval to the variation of Physiomesh in October of the same year. The FDA did express that this shorten approval process meant that the product had not necessarily followed the Federal guidelines and rules.
Hernia Mesh Statistics
Components of Physiomesh
Polypropylene is one of the components that makes up the base layer of the Physiomesh product, the same compound in the bladder slings and the transvaginal meshes that Ethicon also produces. Several thousand claims and lawsuits surrounded both products made with the polypropylene compound. A slim layer of film was placed on either side of the polypropylene to create the Physiomesh product. These slim layers were added to so as to avert the destruction of the polypropylene when it comes in contact with human tissue, which is the scientifically known result of the two meeting.
Physiomesh Withdrawal from the Market
A field safety announcement was made by Ethicon, which expressed that Physiomesh should be immediately withdrawn from use in surgeries for hernia repair; however, denial was perpetually issued by Ethicon and the parent company, Johnson & Johnson, regarding the pulling of Physiomesh from the consumer market. The likelihood of the Physiomesh compounds being the reason for the removing of the device because of the side effects is high. Although, it was stated by Ethicon that the removing of the product from the market concerned the compounds in the polypropylene was addressed in the notice given at withdrawal directly before the pull was made from the consumer market; however, Ethicon said that there were no problems discovered with the product at that time. Ethicon did proclaim that they did not know how to stop the chance of reoccurring hernias, nor could they prevent the complications doctors had seen with the product thus far.
Atrium Medical Corporation, subsidiary of the larger company, The Getinge Group, attempted to improve sales of their product, the C-Qur hernia meshes, by reaching out to surgeons and physicians to communicate encouragement for the using of the product Atrium manufactures called C-Qur. Although, at the juncture this encouragement came, the Food and Drug Administration had already filed several lawsuits surrounding the complications with their product.
Design Defects with Physiomesh
When Physiomesh was discovered to be hazardous to patients, which was since its inception, Ethicon was informed immediately of the dangers. The coatings added to the sides of the polypropylene compound of Physiomesh was intended to protect the patient by keeping the polypropylene from sticking to the tissue of the bowels; however, a serious problem is that if no polypropylene is left exposed, the mesh will not adhere in the correct way to the wall of the abdomen. Not having a clean attachment to the abdominal wall leaves the mesh without stability, meaning that it is possible for the mesh to move freely throughout the body.
A product made of a relatively lower weight was implemented in the designing Physiomesh, as opposed to the earlier model manufactured by Ethicon. The lessened amount was implemented to reduce the risks and side effects seen by the physicians and consumers; although, due to the design, Physiomesh had a far weaker constitution. Due to this weaker design, the product would tear after being implanted in the patient.
There is a direct link with Physiomesh and a multitude of serious complications, including the obstruction of the bowels, seromas, which are fluid pockets that can develop in the body after a surgical procedure, and other failure of the device that can result in severe injury or even death.
Due to the weakened constitution, additional surgical procedures are often required after the implantation of the Physiomesh device, such as the repairing of tears or stabilizing of the mesh after it moved loose. Also, the rate of a reoccurring hernia is significantly higher will patient that have had the Physiomesh implant.
Hernia Mesh Claims and Lawsuits
If it is the case that you or a loved one have had side effects or complications after an implant was placed within the body to repair a hernia, you could be entitled to compensation and we want to help your recovery the compensation you deserve. An experienced product liability lawyer from our firm will help you sort through the damages done to you and get you what you need to get back on your feet. Let us protect your rights to recovery today. Do not hesitate or wait to get your claim filed. Contact Krause & Kinsman immediately to review your case by scheduling a free consultation.
C-Qur™ is a trademark of Atrium Medical Corporation and only written within this article to assist in identify the products. Ventralex® is a registered trademark of C.R. Bard, Inc., and only written within this article to assist in identify the products. Physiomesh® is a registered trademark of Ethicon, Inc., and only written within this article to assist in identify the products.
Our firm is in no way affiliated with, given sponsorship from, legislated by, or associated with Atrium Medical Corporation; C.R. Bard, Inc.; Ethicon, Inc.; or the U.S. Food and Drug Administration.