How do medical device companies get FDA approval, yet still get recalled?

November 14, 2017 – San Diego, CA.  It’s important to realize that every single medical device that has been recalled by the FDA was once approved by the FDA.  Do we see a problem here?

How does this happen and what is the FDA process for approving these medical devices?  Should we trust the FDA or device manufacturer?  This is one reason why so many people take to the internet – searching and trying to find if the medical device they are thinking of is safe and effective in relieving their pain.

Many times when people do these searches they see the manufactures websites, where the companies offer compelling reasons (sales pitches) to choose their products over others.  Let’s remember that these mostly public companies are in the business of making money first, and second to offer people solutions to their medical problem.

Exasperating the problem is the fact that big pharmaceutical companies spend lots of money marketing to doctors with fancy lunches at high-end restaurants, “special events”, monetary reimbursements, and other forms of incentives so that the doctor will talk favorably about that product to the potential patients.

In our blog article last May, we looked at the money being spent on marketing money spent vs. money spent on research and development. It’s quite staggering.  Here are few examples:

Examples of Drug Marketing Cost versus Research and Development include:

  • Johnson & Johnson spent $17. 5 billion on marketing in 2013 versus $8.2 billion in R&D
  • Pfizer spent $11.4 billion versus $6.6 billion in R&D.
  • GlaxoSmithKline spent $9.9 billion versus $5.3 billion in R&D.

Most of these marketing dollars are directed at doctors, and not the general public. Read the entire blog post here:

What is the FDA Procedure for Approving Medical Devices?

We turned to the FDA’s website to see what medical companies have to do in order to get approved. FDA medical device approval

The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.

Medical Device Classifications, Class I, II, and III.

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. To search this database use this link:

Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval.

The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:

  • Establishment registration,
  • Medical Device Listing,
  • Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),
  • Investigational Device Exemption (IDE) for clinical studies
  • Quality System (QS) regulation,
  • Labeling requirements, and
  • Medical Device Reporting (MDR)

We won’t illustrate all of the bullet points above, but will look at the most important one, Premarket Approval (PMA). What is a PMA?

According to the site: “Product requiring PMAs are Class III devices are high risk devices that pose a significant risk of illness or injury, or devices found not substantially equivalent to Class I and II predicate through the 510(k) process. The PMA process is more involved and includes the submission of clinical data to support claims made for the device.”

It’s this bit of regulation that seems to have failed the public in many ways.  When medical devices are approved through the 510(k) PMA process, it means manufacturers can skip the rigorous premarket clinical tests required of other devices so long as there is a “substantially equivalent” product already on the market.

The PMA is also a barrier to lawsuits and makes it difficult for victims to sue a device manufacturer that has a PMA status on their medical device. Companies can say in court that they went through this PMA process and now can’t be held liable if the device fails.

Let’s examine some of the medical devices that have had serious side effects.

When it comes to medical device companies many times they create products that help people with various problems such as knees, shoulder and other joint issues caused by osteoarthritis, rheumatoid arthritis and post-traumatic arthritis. Other devices such as mesh products are used to contain tissue or internal organs that have moved, prolapsed or herniated.

List of known defective medical devices.

The following list is not inclusive of every known medical device, just a sampling from our own website. To learn more about each device and the known side effects or device failures, click each product name.

The bases of recalls can happen in two ways. One is that the manufacturer has issued a recall based on after market testing and found problems not known during device trials.  Or the recall is mandated by the FDA after they have received adverse reports from consumers or lawyers. Many times FDA recalls after a device has a “black box warning” applied to the devices packaging. A FDA black box warning is the highest consumer warning issued by the FDA.  However simply getting a black box warning doesn’t mean the company has to issue a recall, it’s up to the company.


Device:                                 Used for:                                            Side Effect or Malfunction:

Artelon CMS Spacer, treatment for osteoarthritis in thumbs.  Breakage of the device.

Atrium C-Qur Hernia Mesh, used to repair hernias.  Problems of inflammatory response.

Bard 3DMax Hernia Mesh, used to repair hernias.  Device migration and hematoma.

Bard Ventralex ST Hernia Patch, used to repair hernias.  Migration, infections, adhesions.

BHR Hip Implant, for primary hip resurfacing arthroplasty.  Metallosis or cobalt toxicity.

Biomet Shoulder Implant, used to relieve shoulder joint pain.  Recalled for high fracture rates.

DePuy ATTUNE knee System, used for total knee arthroplasty.  Problems of tibial loosening.

Essure Birth control coil implant, used for female sterilization.  Many problems, device migration.

Ethicon Physiomesh, used to repair hernias.  Recalled for recurrence and reoperation rates.

Hip Implants – various makers, used for degenerative hip conditions. Breakage, fails to fuse, other.

IVC Filters, used trap blood clots. Breakage, device migration, device perforated.

Medtronic Infuse Bone Graft, used in spinal cord fusion surgery.  Paralysis, numbness, sterility in males.

Mirena IUD, birth control device.  Possible link to pseudotumor cerebri (intracranial hypertension).

Stryker LFIT V40 Hip Replacement, used for total hip replacements. Corrosion leading to metallosis.

Textured Breast Implants, breast augmentation.  Risk of anaplastic large cell lymphoma cancer (BIA-ALCL)

Vaginal Mesh – various makers.  Used for women with pelvic organ prolapse.  Device protrusion, bleeding infections.

Watchman Stoke Device, used to prevent blood clots.  Recalled due to blood leakage could occur.

Wright Profemur Hip Replacement, for hip replacements. Loosening, severe pain in the hip area, fracturing of the device

Zimmer Persona Knee Implant, for total knee replacement.   Loosening, stiffness, pain, loss of motion.


What recourse do people have when hurt from a defective medical device?

When people are badly injured because of the faulty medical devices, they are often unsure of how they should proceed.medical device lawyers

Most people do not anticipate suffering in this manner and they are not prepared to act immediately if such a situation arises. This understandable lack of preparation is only exacerbated by the fact that people who are seriously injured are generally not in a position to handle preliminary legal work that is necessary in order to properly evaluate a potential claim against someone or something else.

That’s why the medical device injury lawyers at Hood National Law Group offers anyone who has been wrongfully injured the opportunity to contact us to schedule a free initial consultation.

We handle just about every type of medical device injury case that can arise, so you should not hesitate to contact us because you are unsure of whether or not we will be able to help you. You deserve the opportunity to decide how you should proceed with the benefit of honest legal feedback based on decades of experience.

If you have been wrongfully injured or you have lost someone you love from a medical device, all you need to do is complete the form that appears on this page.