510K caused misery and suffering among mesh victims
Sadly, the utilization of the 510(k) process by hernia mesh manufacturers has caused misery and suffering among hernia mesh victims across the world. Some people in North America believe this is an American problem. To the contrary, defective hernia mesh affects victims in the United States, Canada and across the world. Many of these mesh devices have caused severe complications and even lead to death in some cases.
The FDA allows defective hernia mesh device manufacturers to evade clinical reviews using the controversial 510(k) process
Hernia mesh is a Class III high risk device pursuant to federal regulations
Unless the 510k fast track process is utilized, hernia mesh corporations must have new hernia mesh devices submitted to the FDA through the cumbersome Premarket approval (PMA) process. PMA requires clinical trials. Hernia mesh medical devices are considered Class III medical devices. These are: “High-Risk” Devices. These medical devices are designed to support or maintain life. They are critical in preventing impairment of human health. They present a high risk of injury or death if used improperly. These devices are designed to be implanted in the body for sustaining or saving lives. Artificial hearts and automated external defibrillators are prime examples of Class III medical devices.
Premarket approval of Class III device is required by the FDA unless a 510(k) submission gets clearance
The federal regulations that govern premarket approval (PMA) can be found in Title 21 Code of Federal Regulations (CFR) Part 814. “FDA regulations provide 180 days to review the PMA and make a determination. In reality, the review time is normally longer. Before approving or denying a PMA, the appropriate FDA advisory committee may review the PMA at a public meeting and provide FDA with the committee’s recommendation on whether FDA should approve the submission. After FDA notifies the applicant that the PMA has been approved or denied, a notice is published on the Internet (1) announcing the data on which the decision is based, and (2) providing interested persons an opportunity to petition FDA within 30 days for reconsideration of the decision.” FDA
What must be established to obtain a premarket approval of a class three medical device?
The high powered product liability lawyers at the hernia mesh medical device corporations are usually looking to cut corners utilizing the 501(k) process. The mesh attorneys seek to evade proper federal regulatory review so they can maximize profits for the company they are acting on behalf of. These hernia mesh attorneys are willing to put corporate gains over patient and consumer safety. These hernia mesh product liability attorneys do not care that these devices may be defective and cause the following symptoms: “pain, infection, hernia recurrence, scar-like tissue that sticks tissues together (adhesion), blockage of the large or small intestine (obstruction), bleeding, abnormal connection between organs, vessels, or intestines (fistula), fluid build-up at the surgical site (seroma), and a hole in neighboring tissues or organs (perforation). The most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, adhesion, and bowel obstruction. Some other potential adverse events that can occur following hernia repair with mesh are mesh migration and mesh shrinkage (contraction).” FDA Products and Medical Procedures
FDA Requirements to obtain a premarket approval
Below I have set forth some of the stringent regulatory requirements to submit a hernia mesh device for a premarket approval. Considering the overwhelming requirements to get a hernia medical device to the market, it is no wonder that corporate America seeks to fast track products using the “shady” 510k submission process. At the end of the day, the FDA’s primary motivation in the investigation process for premarket approval centers on:
- the structure of the medical device,
- any research on the risk of using the device,
- its benefits to the user and other data that would influence the approval process in order to decide whether or not to approve the device for specific uses.
Here are some of the information and data that must be included to get premarket approval of a hernia mesh medical device by the FDA.
- There must be a device description. This description must explain the functioning of the medical device as well as scientific concepts that underlie the hernia mesh device. The hernia mesh manufacturer and or the lawyers for the manufacturer need to provide its generic name. The device manufacturer must also set forth the proprietary name or the trade name as the case may be.
- The “the data and information in the application constitute valid scientific evidence “
- The applicant must set forth “any adverse effects of the device on health.”
- The applicant must prove that the hernia mesh is “safe and effective for its intended use”
- Pictorial representations as well as a description.
- The applicant must establish properties and principles of operation
- “(iii) Alternative practices and procedures. A description of existing alternative practices or procedures for diagnosing, treating, preventing, curing, or mitigating the disease or condition for which the device is intended.”
- The applicant must provide a short marketing history including a list of the countries such device has been marketed including the United States. Any recall or withdrawal history of the medical device must be included. Also if another person or Business marketed the device, this must be disclosed.
- Summary of studies The applicant must provide very detailed abstract as well as summarizing techical data. This summary must include “a description of the objective of the study, a description of the experimental design of the study, a brief description of how the data were collected and analyzed, and a brief description of the results, whether positive, negative, or inconclusive.”
- “A summary of the clinical investigations involving human subjects submitted in the application including a discussion of subject selection and exclusion criteria, study population, study period, safety and effectiveness data, adverse reactions and complications, patient discontinuation, patient complaints, device failures and replacements, results of statistical analyses of the clinical investigations, contraindications and precautions for use of the device, and other information from the clinical investigations as appropriate (any investigation conducted under an IDE shall be identified as such). TITLE 21–FOOD AND DRUGS CHAPTER I–FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H–MEDICAL DEVICES, PART 814 PREMARKET APPROVAL OF MEDICAL DEVICES [CITE: 21 CFR 814]
If a Premarket approval for a hernia mesh device is not granted by FDA- such mesh is adulterated!
It all makes sense now. The hernia mesh medical device manufacturer’s are afraid that their medical device will be determined to be adulterated by the FDA. As a result the hernia mesh manufacturers cowardly try to evade INTENSE FDA review through the 510(k) process.
If a class III medical device does not meet the requirements set forth in 510(f) of the Food Drug & Cosmetic act then the FDA considers such device adulterated and such medical device cannot be marketed. TITLE 21–FOOD AND DRUGS CHAPTER I–FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H–MEDICAL DEVICES https://www.fda.gov/ForPatients/Approvals/Devices/ucm405378.htm , Part 814 premarket approval of medical devices.
What is a 510 (k) premarket notification?
The official title of the document is an FDA 510(k) submission. In reality, the Federal Drug Administration (FDA) does not put its stamp of approval on any of these devices. Rather, if approved, it gives a legal “clearance” to the device to be sold within the US. In addition, manufacturers who wish to change the use of an approved device or want to change the technology that supports a previously cleared device must also submit a 510(k) request.
“Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, “new” devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected.” FDA, Device approvals and clearances, 510k
In order for a manufacturer to sell a Class II or III medical device or a vitro diagnostic device (IVD) for human use in the US, they must file a Premarket Notification with the FDA. (assuming a PMA is not required) “Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the Act)…” ” FDA premarket submission ,
In order to obtain Section 510(k) clearance a hernia mesh corporations must:
- file a Section 510(k) premarket notification of its intent to market
- “make and support” and demonstrate their equivalency claim that the medical device is at least as safe and effective as—that is, substantially equivalent to another medical device which had been previously cleared by FDA (clearance could be through previous devices’ 510 (K) premarket fda approval
What is the FDA 510(k) Approval Process?
- . File your 510(k) Premarket Notification (PMN) with the FDA.
- Wait at least 90 days.
- During this waiting period, the FDA with analyze the PMN and decide if your device falls in Class II and is “substantially similar” to any other item already on the market.
- If the device is similar, the FDA may go ahead and allow the item to be marketed without testing. With a 510(k) clearance, the can manufacturer begin the marketing process without passing the time-consuming Premarket Approval (PMA) process.
- Class I medical items do not need a 501(k) FDA clearance.
- All Class III medical devices must go through the complete Premarket Notification testing process and receive an official clearance before the devices may be brought to market.
What medical devices have been fast tracked using the 510k process?
It is apparent that the FDA 510(k) application process is the root of the problem for defective hernia mesh.
- Ethicon Physiomesh™- In May 2016, Ethicon addressed an urgent field safety notice to healthcare providers indicating that it was withdrawing physiomesh™ flexible composite mesh from the global market. This was after an analysis which suggested that the product was associated with high revision and recurrence rates in laparoscopic ventral hernia repair as compared to other meshes.
- Ethicon was marketed in 2010 into the mesh medical device market. Ethicon Corporation accelerated the hernia mesh known as Physiomesh™ utilizing the controversial FDA 510 (k) PMN process. Ethicon’s 510 (k) premarket approval application was filed on March 18, 2010 to the FDA. The hernia mesh medical device “Physiomesh™ was marketed after the FDA gave “clearance” in April 2010. Read Ethicon’s 510(K) SUMMARY. In that 510k process, Ethicon asserted that ETHICON Physiomesh™ is substantially equivalent to: PROCEED Mesh, ULTRAPRO® Hernia System and ULTRAPRO® Mesh. Id. Ethicon’s corporate lawyers, in United States Federal Court, gave a detailed account on how ETHICON Physiomesh™ was approved by the FDA. “In December 2009, Ethicon submitted to the United States Food and Drug Administration (“FDA”) a Section 510(k) premarket notification of its intent to market PHYSIOMESH. By a letter dated April 9, 2010, FDA cleared Physiomesh™ as a Class II prescription device on the basis that it was at least as safe and effective as—that is, substantially equivalent to—Ethicon’s PROCEED Mesh, ULTRAPRO Mesh, and ULTRAPRO Hernia System, all of which had been previously cleared by FDA under the 510(k) process. Thereafter, Ethicon began marketing Physiomesh™ to surgeons. Ethicon decided to withdraw Physiomesh™ from the global market in May 2016.” DEFENDANTS’ RESPONSE IN OPPOSITION TO PLAINTIFFS’ MOTION FOR TRANSFER PURSUANT TO 28 U.S.C. § 1407 The FDA determined that “ETHICON PHYSIOMESH, Flexible Composite Mesh met all testing criteria, demonstrated substantial equivalence to its predicate devices and did not raise any new questions of safety or effectiveness.” Approval letter from FDA to Ethicon dated April 9, 2010 “We have reviewed your Section 5 10(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce…” Id.
C.R. Bard, Inc and Davol Inc. 510(k) premarket hernia mesh and hernia patch submissions:
In case you were wondering about the extent to which hernia mesh manufacturers are reliant and dependent on 510(k) submissions below you will find a list of Mesh and patches in which Davol, Inc and C.R. Bard, Inc utilized the 510(k) notification process. This list does not indicate that these products are defective or were recalled or removed. This is very sad.
|Bard Ventralex Hernia Patch||C.R. Bard, Inc.||K132441||12/13/2013|
|Small Perfix Light Plug With 6 X 13.5 Cm||C.R. Bard, Inc.||K153236||05/13/2016|
We are reviewing potential claims of defective hernia mesh medical devices, made of non-absorbable polypropylene that may have caused injuries, including:
- Ethicon Physiomesh™
- Atrium C-QUR
- Composix® Kugel® mesh patches (manufactured by C.R. Bard subsidiary Davol)
- All C.R. Bard mesh patches made of Marlex polypropylene
- ventralight st mesh