An interview with Ann Becker Schutte, Ph.D Last year, for the first time, I attended Stanford...READ MORE
What Are They Selling? How and Why Transvaginal Mesh Devices Were Marketed to an Unsuspecting Public
Our country has many systems in place that help keep us safe. From what we eat, to car airbags, to what medicines we take — we assume we are being protected. If a product is not up to safety standards we assume that the manufacturer will take the product off the market until the issue is resolved. And we put a lot of confidence in the Food and Drug Administration (FDA) to step in when necessary, issuing product recalls or safety warnings – especially when it comes to pharmaceuticals.
But real life doesn’t always work like that. Instead, the FDA often relies heavily on the manufacturers of products to provide objective information about the product’s risks and benefits.
Sadly, these companies sometimes fail to recognize or raise important safety considerations.
Pharmaceutical companies are mostly huge, global, corporations that earn billions of dollars a year. As much as we hope that their first goal is to protect and remedy patients’ illnesses, the truth is, the financial bottom line is foremost in importance for pharmaceutical companies.
Thanks to the way generic medicine is made and sold, pharmaceutical companies have a limited amount of time to turn a profit on their original formulas before the generic product enters the field and swamps "the competition," i.e., the original corporation that spent millions investing in the product in the first place.
What this means is that in order to stay competitive and ensure a favorable bottom line, pharmaceutical companies have to rely on big ticket winners, so to speak, to make enough money to offset loses involved with generics and drugs that just don’t make it.
One way they do this is by promoting medical drugs and devices to as many people as they can. This way, pharmaceutical companies — who think in terms of short-term gains — are able to reap as many sales as possible, quickly. Just as it is common for generic products to enter the market and flood "the competition," it is also rather common for drugs to have "a short shelf life" and be taken off the market because of safety concerns, for instance. What this means is: Sell as much as possible. The faster, the better.
The companies who made transvaginal mesh did a wonderful marketing those products to doctors. They said their transvaginal mesh devices could cure some of the most common complaints of many women [FYI: our youngest client was born in 1972]. They said there was minimal upkeep — just an easy surgery and you won’t have to think about it again! They even manufactured the transvaginal mesh devices in "kit forms" so the insertion surgery was easier for surgeons. From a marketing standpoint, they did everything right.
But as many women can attest, transvaginal mesh is definitely not always an easy solution to bladder incontinence or pelvic organ prolapse, and it is definitely not as safe as the manufacturers of these products claimed they were.
If you have encountered a problem with a TVM implant, please alert the FDA through their notification process. The FDA cannot start to see patterns emerge or discover problems that are not reported. You can alert the FDA to particular issues you may be dealing with at https://www.accessdata.fda.gov/scripts/medwatch/