Boston Scientific, Coloplast Ordered to Stop Selling Surgical Mesh
Posted on Friday, December 6th, 2019
FDA Pulls Transvaginal Mesh Due to Safety Concerns
Friday, December 6, 2019 – Two of the most prominent companies in the transvaginal mesh industry, Boston Scientific and Coloplast, have been ordered by the US Food and Drug Administration to stop selling surgical mesh used to treat pelvic organ prolapse (POP), including posterior and anterior compartment prolapse. The move comes after years of reports that transvaginal mesh use has resulted in life-altering, painful complications.
A statement issued by the FDA earlier this year reads, “The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated reasonable assurance of safety and effectiveness for these devices, which is the premarket standard that now applies to them since the agency reclassified them into class III (high risk) in 2016.
“Since the FDA has not received sufficient evidence to assure that the probable benefits of these devices outweigh their probable risks, the agency has concluded that these products do not have reasonable assurance of safety and effectiveness. The companies will have 10 days to submit their plans to withdraw these products from the market.”
FDA Approved Transvaginal Mesh for Sale, Not for Safety
Surgical mesh has been used since the 1950s, when it began as a hernia repair solution. Twenty years later, in the 1970s, surgeons began to use it to reinforce pelvic muscles weakened by pregnancy, age, surgery, or other factors — a condition known as POP.
As transvaginal mesh rose in popularity, manufacturers developed mesh that could be inserted through the vagina. Boston Scientific was the first to market transvaginal mesh, called ProtoGen Sling, in 1996.
ProtoGen Sling gained approval by the FDA, not because it was determined safe and effective, but through the FDA’s fast-tracked 510(k) premarket notification process. Through this process, the FDA does not determine these medical devices to be safe; it determines that they can be sold.
The 510(k) process does not require clinical trials. It simply requires a “predicate device” (hernia mesh, in this case) believed to be the “substantial equivalent,” to be on the market. To gain approval, companies must file some paperwork, pay a few thousand dollars in fees, and wait for about 90 days.
Though transvaginal mesh was predicated on hernia mesh, it, too, has had its share of safety risks and complications that were ignored for years by the industry. In fact, thousands of lawsuits have now been filed due to many of the same types of complications that patients have experienced with transvaginal mesh.
In the next years, ProtoGen Sling and its successors became popular because they were less invasive, and the initial healing process appeared to be shorter and less difficult for patients compared to mesh that had previously been placed using abdominal surgery.
In the following months, several ideations of vaginal mesh were rushed through approval by a number of different companies, including CR Bard, American Medical Systems, Coloplast, Boston Scientific, Cook Medical, Caldera, and DIMA/Neomedic. Each of the new devices was approved for sale by the FDA through the 510(k) process because ProtoGen Sling was their predicate device.
Three years later, in 1999, safety concerns led to a recall of ProtoGen Sling. Even though other vaginal mesh products had been approved for sale based on the presumed safety and efficacy of ProtoGen Sling, the FDA did not raise a red flag for the other devices once those concerns were raised.
The companies selling these devices were not required to do further testing, and no consumer warnings were issued stating that other mesh products may also pose risks. The companies selling transvaginal mesh products continued to do so, at best avoiding the possibility that there may be problems, and at worst, willfully ignoring red flags for the sake of profits.
Complications of Transvaginal Mesh
By 2011, the FDA had accumulated a large number of reports that transvaginal mesh was linked to infection, pain, narrowing or perforation of the vaginal wall, and other serious problems that occurred both during surgery and afterward. Scarring, encapsulation, pain, nerve damage, and emotional problems were also linked to mesh.
The FDA also learned that the conditions vaginal mesh was being used to treat, such as prolapse and urinary incontinence, were recurring in some women who had transvaginal mesh implants.
In many cases, removal of transvaginal mesh was found to be the only solution, yet it proved to be a difficult process.
Transvaginal mesh is supposed to be permanent. It is designed with pores so that tissue can grow through and around it. Typically, surgeons must remove it in stages, which can require multiple painful surgeries. Women have also experienced hematomas, abscesses, blood loss during surgery and other potentially dangerous complications.
FDA Steps Up to Halt Sale of Transvaginal Mesh
In 2016, transvaginal mesh used for POP was reclassified by the FDA as a high-risk device. Companies that wished to market a transvaginal mesh products became required to submit premarket approval (PMA) applications, the FDA’s most stringent pathway for medical devices.
The FDA made a formal statement saying that mesh’s adverse effects were “not uncommon,” and that the surgical outcomes of women who have had mesh implants were not conclusively better than those who have relied on other methods.
The new approval process cut into profit margins for the companies involved, and every one of them stopped marketing surgical mesh for use in transvaginal repair of posterior compartment prolapse. Anterior compartment prolapse (cystocele) was still being treated with surgical mesh, and the problems persisted.
In April 2019, following mounting evidence that surgical mesh was linked to serious medical problems, the FDA determined that Boston Scientific and Coloplast “have not demonstrated reasonable assurance of safety and effectiveness for these devices.”
The FDA also ordered all companies marketing and selling mesh to be used for cystocele treatment to immediately remove their products from clinic and hospital shelves.
Transvaginal Mesh Lawsuits
In recent years, tens of thousands of women have come forward with claims that transvaginal mesh use resulted in often serious complications. OnderLaw, LLC in St. Louis, MO is handling hundreds of these cases, and litigation is ongoing.
Potentially, many women may be compensated for medical bills, lost wages, pain and suffering and other damages related to their transvaginal mesh.
Attorneys representing these cases believe that those who have suffered adverse effects of transvaginal mesh have done so needlessly. They say the companies that sold these devices did so despite knowing adverse effects, and despite bans on similar products. In short, they believe that these companies put profits over the safety and well-being of the people who used them.
What to Do if You Have Transvaginal Mesh
If your doctor has used transvaginal mesh to repair your POP and you have not had complications or symptoms, including pelvic or groin pain, persistent vaginal bleeding, pain during sex, or discharge, continue to visit your healthcare provider as scheduled. If he or she does not already know, be sure to tell your provider that you have had a transvaginal mesh implant.
Women who have received transvaginal mesh for the surgical repair of pelvic organ prolapse should continue their routine check-ups and follow-up care. There is no need to take additional action if you are satisfied with your surgery and are not having any complications or symptoms.
If you are experiencing symptoms or complications, it is important that you visit your healthcare provider. Also, contact an Onder Law attorney who specializes in transvaginal mesh lawsuits. We will guide you so that you are not left with medical expenses and other burdens. We stand up for your rights so that you can focus on healing.
Contact Onder Law, the transvaginal mesh lawyers in St. Louis. We don’t get paid until you do, and we will fight for you.