In the last few years, there has been much controversy surrounding the FDA and its approval process of medical devices. Until several products began causing serious problems in patients, the public wasn’t aware that these medical devices most often go through the most minimal, lax approval process. Transvaginal Mesh is one of those devices. Marketed to doctors and women as a safe alternative to stitches, TVM was inserted in thousands of women who are now suffering life-altering complications from it.
A Nurse’s Experience with Mesh
Recently, PBS aired a special bringing attention to one particularly sad case of medical devices gone completely wrong: transvaginal mesh. The show featured a nurse, Linda Gross, who received the implant and then had to have 22 subsequent surgeries to deal with her constant pain. She suffered excruciating pain that began immediately after the surgery and only worsened. Before the surgery, she had been told by the doctor that if the surgical mesh did not do well in her body, they could surely remove it without incident. The literature she received from the manufacturer (Johnson & Johnson subsidiary Ethicon) stated the same. There was not a single statement that transvaginal mesh was a permanent implant.
Five months after the implant was inserted, Linda was unable to sit without pain, nor was she able to work or perform the most basic tasks at home. Completely disabled, she decided to have the mesh removed. If only it were that simple. Twenty-two surgeries later, her family’s life savings were depleted, and she had to quit her job, unable to work.
After the manufacturer was no help in trying to remedy the situation, Linda filed a lawsuit against Ethicon and Johnson & Johnson. She was awarded $11.1 million dollars in compensatory and punitive damages for fraudulent misrepresentation and failure to provide adequate warning.
There are thousands of other women who have had the misfortune of suffering similar fates as Linda’s. They suffer constant pain, bleeding, and the inability to engage in sexual intercourse. What makes this situation even more upsetting is that there is no evidence that Johnson & Johnson knew that there were real risks to this product, but sent it to market anyway. They ignored evidence that women with surgically implanted mesh had high chances of complications and pain while having sex. Instead, of trying to beat another manufacturer to market with their product, they thought that they’d deal with it later. And dealing with it they are. From 2005 to 2012, Johnson & Johnson made over $108 million off of mesh, but now they are facing thousands of lawsuits from women like Linda Gross. Women who trusted that they were being implanted with a legitimate device, only to end up with crippling, unending pain.
The FDA Approval Process that brought Mesh to Market
How did this happen? Much of the public might think that this is the very reason that the FDA exists: to protect the public from drugs and devices gone wrong. What many people don’t know is that every drug and device does not receive thorough consideration, reviewing, and testing before hitting the market and becoming available to the public. In fact, many devices don’t even receive the most minimal testing.
Through what is called the 510(k) Approval Process for low to moderate risk devices, a manufacturer can submit that their new device is substantially similar to an old device that was approved and on the market. Through a few questions, the FDA can decide if it agrees. If it does agree, these products can end up on the market with zero independent testings. Essentially, the manufacturer piggy-backs off of other products on the market.
Pros and Cons
The problems with the availability of this approval process are obvious. Even if these devices are considered to pose low to moderate risk, when the device goes wrong inside of someone’s body and can not be removed, the effect of this on a patient’s life is huge. It is not just transvaginal mesh that has affected so many people, it is also metal on metal hip implants and defibrillators that have gone through similar approval processes and have similarly devastating effects on patients.
Advocates of the process say that without such expedited approval processes available to manufacturers of medical devices, there would be no innovation, leading to limited growth and availability to consumers in need of medical devices. Allowing manufacturers to build upon the advancements of products that have come before is reasonable. These advocates say that if such products got stuck in the FDA pipeline, it would add over 4000 applications into the already slow FDA approval process. This, they say, isn’t in the public’s best interests.
In theory, this makes sense. In practice, however, the picture is less rosy. Innovation is wonderful, but it should not come at the price of safety. While consumers do benefit from new products coming onto the market quickly, these products are of no use if they put a patient’s well-being at risk. While every drug or device has some risk, it is unacceptable for manufacturers to ignore known risks in order to bring a device to market quickly.
Though the manufacturers would like to claim innovation as their prime motivator, it is easy to see that it is actually profit that is the real motivator. Especially in the case of transvaginal mesh, the market was not in desperate need of such a product. Stitches were a perfectly acceptable solution to many of the problems mesh was designed to address, without the awful side effects. The real reason that Ethicon used the 510(k) approval process was to start making money as quickly as possible.
The FDA assembled an independent board of medical experts to review the FDA’s expedited approval process. The board concluded that the process is very flawed and that the FDA needs an “entirely new framework”. However, the FDA is still reluctant to do away with the process, likely because it would create so much more work and backlog.
How to Make the Process Better
The abbreviated approval process undoubtedly has benefits, as explained above. But too often speedy approval is coming at the price of safety. What can be done to find a middle ground? On the PBS show, Dr. Joshua Rising explained one way that the FDA might keep the 510(k) approval process while improving safety statistics.
If a registry of implant recipients was kept, with follow-up information to track how each device was doing after implantation, trends in problems with devices would come to light much quicker than they do now. In Australia, a registry like this is in place, and problems with metal on metal hip implants came to light much quicker in that country than they did in the U.S. The FDA is in the process of trying to create such a process in the United States.
What You Can Do to Protect Yourself Now
Until the FDA works these issues out, patients need to be more aware and take better steps to ensure their own safety. It is dangerous to rely on manufacturers or the FDA to safeguard your health.
Your best defense is to take thoroughly about any proposed medical devices with your doctor before agreeing to any procedure. Though you might be in pain and it may be tempting to believe a proposed procedure will bring you relief, first try to gather as much information about the device as possible.
Ask your doctor how many procedures he has performed. The most important question to ask your doctor is how the follow-ups have been with patients who have received the medical device. Have there been complications that have shown up often? How are these complications addressed? What alternatives are there to this device? Discussing thoroughly how other patients have fared is the best way to decide whether or not this device is right for you. Your doctor should be open and willing to discuss these matters with you. If she is not, consult another doctor.
Contact the Transvaginal Mesh Attorneys at Kirkendall Dwyer LLP for Help.
Have you received a transvaginal mesh implant? If you or a loved one have had complications, our Transvaginal Mesh Attorneys are here to help you. We have helped many women receive the medical and legal attention that they need in order to deal with their pain and complications. You don’t need to suffer alone. Call us today to begin the process of recovery. Thousands of women have gotten medical help and gone on to seek compensation for their injuries. Let us help you. Call us or fill out a form to begin your free case review.