Male Mesh Sling Recalls Prompts Question: Why Are So Many Faulty Medical Devices Approved by the FDA?
The United States Food and Drug Administration recently announced that two different types of male mesh sling have been recalled due to the risk of injury associated with them. These devices, which are primarily used to treat urinary incontinence, have been linked to claims of infections, persistent pain, and other complications. Some men have even suffered from the migration or erosion of the mesh sling. The device impacted the surrounding organs and tissue in these patients’ bodies.
The male mesh sling in question is made of polypropylene. Polypropylene is described by many scientists as being a cheap polymer that is not designed to last for the length of a patient’s life. If this is the case, then why was the mesh ever approved by the FDA?
Medical devices are not subjected to the same testing standards that medications are. In fact, it is much easier to obtain approval for a medical device than a medication.
The approval process for medications
Most medications take years to gain FDA approval. They must undergo a series of clinical trials. After the drug has made it through the pre-clinical trial process, the pharmaceutical company must test the drug in its first phase of clinical trials. Generally, fewer than 100 volunteers comprise the subject group for the first clinical trial. The first phase lasts about a year. The company evaluates the impact of the drug on the body, analyzes a proper dosage, and examines the group’s tolerance of the medication.
Next, in Phase II, between 100 and 300 volunteers take the drug for a couple of years. During this phase, the drug’s effectiveness is evaluated if the medication has been tolerated by the test group. The drug’s efficacy, as well as its short-term side effects, are evaluated in this phase.
In the third phase, somewhere between 1,000 and 3,000 patients are monitored while taking the medication. Phase III usually lasts about 3 years. During this phase, the medication’s efficacy and side effects are further examined. Once the results are published from this phase, the FDA approval process may begin. Approval may take another two years or so.
The approval process for medical devices
Medical devices usually take between 3 and 7 years to obtain FDA approval. In contrast, most medications take around 12 years.
Medical devices are split into three classes. Class I devices have a low risk of injury or illness, Class II devices present a moderate risk, and Class III devices “sustain or support human life” or pose an “unreasonable risk of illness or injury.”
Both Class I and Class II devices have more relaxed standards for approval as compared to Class III devices. However, if a Class III device is similar to devices that have already been approved by the FDA, they can actually be relabeled as Class I or Class II devices.
The majority—around 75 percent—of Class I devices are of “exempt” status, which means that clinical trials—or even proof of efficacy or safety—are not required. Some Class II devices are also exempt. Still, the majority of Class II devices do not need clinical trial data to obtain approval.
Therefore, human trials may not ever be conducted on a medical device before it hits the market.
Were you seriously injured by a medical device?
If you have been harmed by a male mesh sling, contact Parker Waichman LLP today. Our attorneys are experienced in medical device injury claims and will obtain the compensation you deserve. To schedule a free consultation, call 1-800-YOURLAWYER (1-800-968-7529).
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