Preview Newsletter
Ethicon Media Monitoring 10/05/16
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Boston Scientific loses bid to toss $19m pelvic mesh loss
Oct 4, 2016 | Mass Device
By Brad Perriello
Boston Scientific (NYSE:BSX) yesterday lost its bid to overturn an $18.5 million loss in a product liability lawsuit brought by a quartet of women alleging that its Obtryx pelvic mesh caused their injuries. -
SUBROGATION & MESH– What it means and why you must understand it
Oct 4, 2016 | Mesh Medical Device Newsdesk
By Aaron Leigh Horton
According Dr. Shlomo Raz at UCLA, the leading expert for 100% removal of transvaginal mesh from the body, “I think that more than1 million patients [have polypropylene mesh implanted]! The companies have reported insertion of 250,000 implants per year! This number is an estimate of the worldwide use of mesh.” -
AUGS: Mesh Procedures Left After Litigation
Oct 4, 2016 | Mesh Medical Device Newsdesk
The American Urogynecologic Society’s 2016 PFDWeek (pelvic floor disorders) featured pre-conference workshops about the procedures still on the market to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), but the undercurrent of pelvic mesh litigation was still on the minds of many. -
AUGS – Patient Presence Missing from Urogyn Society Meeting
Oct 5, 2016 | Mesh Medical Device Newsdesk
With an emphasis on innovation and advancement in the practice of urogynecology, at the AUGS annual conference of specialists, there were few reminders about the outcomes of, what’s been described as the darkest chapter in women’s health history, that is, the patient presence. -
ProteGen – The First Mesh, a 20 Year History
Oct 3, 2016 | Mesh Medical Device Newsdesk
Of the sixty or so pelvic meshes that were or currently are on the market in the United States you may not have heard of the ProteGen mesh, a model designed and manufactured by Boston Scientific. The ProteGen was the first transvaginal mesh approved in the U.S. in November 1996.
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Boston Scientific loses bid to toss $19m pelvic mesh loss
Oct 4, 2016 | Mass Device
By Brad Perriello
Boston Scientific (NYSE:BSX) yesterday lost its bid to overturn an $18.5 million loss in a product liability lawsuit brought by a quartet of women alleging that its Obtryx pelvic mesh caused their injuries.
A jury in West Virginia federal court in November 2014 found Boston Scientific liable to 4 women following a 10-day trial; the trial judge later ordered the Marlborough, Mass.-based company to pay each of the 4 women damages ranging from $3.25 million to $4.25 million (the 4th plaintiff later settled her case out of court and it was dismissed).
Boston Scientific last year asked Judge Joseph Goodwin, of the U.S. District Court for Southern West Virginia, to overturn the verdict, arguing that the plaintiffs failed to show that Obtryx is not reasonably safe because it’s within the standard of care for stress urinary incontinence. The plaintiffs also failed to link any of their injuries to specific design flaws, the company argued, and likewise didn’t prove their failure to warn claims. Boston Scientific also argued that the punitive damage awards were excessive and caused a miscarriage of justice.
Goodwin disagreed, declining to disturb the jury verdict because “there was more than sufficient evidence from which a reasonable jury could find in favor of the plaintiffs on each of their claims,” according to court documents.
“[Boston Scientific] 1st argues that the plaintiffs failed to establish that the Obtryx is ‘not reasonably safe’ because it is within the standard of care for the treatment of SUI. BSC conflates the standard for medical malpractice with that used for strict liability,” Goodwin wrote. “Here, the question is whether the manufacturer used reasonable care in designing the Obtryx.
“Accordingly, despite expert testimony indicating that use of the Obtryx is within the standard of care in the medical community, a reasonable jury could balance the risks and benefits based on the significant evidence the plaintiffs produced at trial on the Obtryx’s risks,” the judge wrote. “From this evidence, a reasonable jury could conclude that the risks associated with the Obtryx are not justified by its benefits and, as a result, the product is not reasonably safe.”
On the design defect claims, Goodwin found that “a reasonable jury could conclude that the Obtryx is not reasonably safe based on evidence of the specific defects discussed above (e.g. difficulty of removal; contraction, shrinkage, and banding; degradation; scarring).”
“Because I find that the plaintiffs’ experts specifically connected at least 1 of the above defects to each plaintiff’s injuries, a reasonable jury would have no need to ‘infer the existence of a defect by circumstantial evidence,'” he wrote. “The design defects discussed above, which were specifically linked to the plaintiffs’ injuries through expert testimony, likewise could have been revealed through clinical testing of the Obtryx. Therefore, a reasonable jury could find that BSC’s failure to conduct clinical trials before marketing the Obtryx proximately caused the plaintiffs’ injuries.
“In sum, BSC knew that safety issues can arise when a product does not undergo clinical testing, failed to respond to explicit warnings from the manufacturer that polypropylene should never be used permanently in the human body, and suggested hiding negative studies to physicians considering using the Obtryx. Drawing all inferences in the light most favorable to the plaintiffs, I find that a reasonable jury could use this evidence to conclude that BSC’s conduct justified an award of punitive damages,” Goodwin wrote.
Boston Scientific alone is facing some 19,000 individual cases in the multi-district litigation over its pelvic mesh products, out of the more than 70,000 cases pending in MDLs against that company and other pelvic mesh makers including C.R. Bard (NYSE:BCR) and Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon, according to the documents.
http://www.massdevice.com/boston-scientific-loses-bid-toss-19m-pelvic-mesh-loss/
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SUBROGATION & MESH– What it means and why you must understand it
Oct 4, 2016 | Mesh Medical Device Newsdesk
By Aaron Leigh Horton
This story first appeared in October 2016 but deserves to be revived as many are currently in the process of receiving settlement in their mesh injury case. Thank you Aaron!
According Dr. Shlomo Raz at UCLA, the leading expert for 100% removal of transvaginal mesh from the body, “I think that more than1 million patients [have polypropylene mesh implanted]! The companies have reported insertion of 250,000 implants per year! This number is an estimate of the worldwide use of mesh.”
Obviously, that is an enormous number, and when broken down to a daily figure, it represents at least 685 patients worldwide, per day that are still receiving this highly-injurious medical device. As a result, many victims (more than 50,000 in the U.S. and growing) have filed suit against the six manufacturers of this mesh, most often used in women for pelvic organ prolapse (POP), stress urinary incontinence (SUI) and more and more for hernia repair, performed on both men and women.
So as some of the earlier cases near settlement talks and bellwether trials are underway, claimants will be wise to understand the components that make up a jury-awarded damage or a settlement figure, negotiated without a jury between the plaintiff and defendants lawyers and clients.
Subrogation is an important term that plaintiffs will want to discuss with their legal representation. Subrogation is a legal term that refers specifically to a third party’s right to recover damages out of a victim’s possible award and/or settlement.
According to Mr. Doug A. Daniels, attorney/partner and a specialist in mesh cases:
“Subrogation refers to the principle that someone who pays another person for damage caused by a third person, has a right to recover those payments from that third person who caused the damage; if the victim recovers an amount from the third person, the party who paid for the damage has a right to be paid back out of that recovery. Subrogation would apply in the mesh cases as in any other case: Third-party payers (Medicare, Medicaid, or private insurers) have and will assert a right to be reimbursed out of the victims’ recovery against the defendants. That right to reimbursement is limited to amounts they paid on behalf of the victims for treatments related to injuries caused by the mesh. That is, they are not entitled to by repaid amounts out of mesh lawsuit settlements that they paid for treatments unrelated to the mesh injuries.”
In plain English, subrogation means that a health insurer has the legal right to a portion of a mesh-injured patient’s financial settlement. Understanding the realities of the cash disbursement you may receive is very important. Several entities have legal right to claim a portion of financial damages a plaintiff is awarded, including:Your lawyer, depending on the language in your contract, even if you do not go to trial but instead settle, with no trial required.A portion of your cash award will also be subject to subrogation as described above, and insurance companies have the right to place liens on your personal property until they have received their negotiated portion of the award. Often, your attorney will handle this process with companies who specialize in the negotiation of subrogation.Tort reform law is different per state. As a plaintiff, it’s important to know how tort reform law has affected your state’s practice. For example, in Texas, there is an automatic cap on compensatory damages of $250,000 and punitive damages cannot exceed 3x the economic value lost, due to the injury/illness. As another example, in Georgia, compensatory damages are also capped at $250,000, but punitive damages are immediately subject to a 75% fee, assessed by the State of Georgia.
According the Mr. Daniels, it’s also imperative for plaintiffs to know that, “Medicare and Medicaid don’t even have to demand to be paid back; the law mandates it.” He’s also not aware of any private insurer that does not pursue their legal right to subrogation.
How does our payment of health care premiums factor in to the equation of what will be recouped by third parties through subrogation? According to Mr. Daniels, “Premiums are not part of the subrogation analysis since [the injured patient] also buys coverage for other medical treatment unrelated to whatever injury gives rise to the settlement.”
Daniels concedes there is a bit of a flaw in that logic since the recoup of financial damages represents the victim’s recovery for more than just medical expenses. Recovered damages also include lost earnings, pain and suffering, loss of enjoyment of life, etc. Who’s to say what part of a given settlement represents medical expenses only as compared to other more subjective damages, like loss of future earnings/productivity, loss of consortium, loss of intimacy and the many other harms we know are not primarily medical in nature, but are a by-product of the physical injuries for which the mesh is responsible? It’s in this area that lien resolution companies step in to work with a plaintiff’s lawyer to negotiate a reasonable recovery to the third-party payer (your insurer) while still reserving a reasonable net recovery for you, the victim.
Aaron Leigh Horton is a regular contributor to Mesh News Desk. This article is not intended to be a substitute for legal advice from your own law firm. Please confer with them about this important topic.
http://www.meshmedicaldevicenewsdesk.com/subrogation-mesh-what-it-means-and-why-you-must-understand-it/
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AUGS: Mesh Procedures Left After Litigation
Oct 4, 2016 | Mesh Medical Device Newsdesk
The American Urogynecologic Society’s 2016 PFDWeek (pelvic floor disorders) featured pre-conference workshops about the procedures still on the market to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), but the undercurrent of pelvic mesh litigation was still on the minds of many.
he ethical considerations behind exploring new technology in minimally invasive surgery brought my husband and I to a Tuesday morning session, September 27, Advances in Laparoscopy and Robotic Reconstructive Pelvic Surgery.The course faculty was Kevin J. Stepp, MD, of the Carolinas Healthcare System in Charlotte, Andrew Sokol, MD of George Washington University Hospital and John Miklos, an Atlanta area urogynecologist were on the panel.
Up for discussion was abdominal sacral colpopexy (ASC), considered the Gold Standard of pelvic surgery, now that most of the major pelvic organ prolapse (POP) meshes have been taken off the market.
Does robotic surgery offer a novel improvement to traditional surgery? What are the responsible and ethical consideration for exploring a new technologies in minimally invasive surgery, especially considering 100,000 lawsuits that have been filed against polypropylene pelvic mesh?
A sacral colpopexy is prolapse of the top of the vagina downward, not uncommon after a hysterectomy. The procedure can use mesh, porcine (pig), cadaver fascia or tissue from the patient. The goal of the abdominal surgery, which can be done laparoscopically, is to replicate the natural anatomic support normally presented by the uterosacral and cardinal ligaments.
The panelists agreed – they are getting more requests to do the procedure without mesh but biologic products, the data shows, doesn’t work as well, said one. Then there is the concern about intestinal and urinary tract injuries from trocars, used during the procedure, as seen in the Baggish report, said another.
The sacrospinous ligament fixation is surgery that restores the uterus or vaginal vault to its natural position in a woman who has had a hysterectomy. The stitches can be permanent or absorbed over time.
An estimated 11 percent of women will require one of these surgeries in her lifetime says the IUGA, International Urogynecological Association.
EARLY ADAPTERS
Robotics promise the latest and greatest technology that some doctors will turn to but each machine costs roughly $2 million plus annual maintenance. Many will jump on the technology bandwagon like driverless cars, but even with robotics, not everyone is of the same skill set, warned Dr. Miklos.
In a power point presentation, Miklos said early adapters are driven by image, ego, the institutional culture, a risk taker personality and the promise of financial gain. Later adapters are generally more conservative, risk adverse, and have less financial reason to adopt a new process or product.
Dr. Miklos was an early adaptor and the first to bring the TVT (tension-free vaginal tape) to the U.S. from Sweden. Even though today he has misgivings, he still supports the use of TVT mesh for incontinence, but many who followed were challenged by the steep learning curve.
“It’s important you identify your forte and extrapolate and utilize to the best of your ability to meet the needs of your patients.” Patient first and your reputation follows, he said.
Later in the day another discussion, Mesh Graft Use in Pelvic Reconstructive Surgery, led by Drs. Lucente and Cassidenti, was supposed to focus on surgical options.
Instead, a defense lawyer was present. Lisa Floro is the Associate General Counsel for Urology Care for Coloplast, a manufacturer based in Denmark that makes healthcare products and is one of seven mesh manufacturers facing 2,550 product liability lawsuits in federal court in Charleston, WV.
It was her job to describe the “Cycle of a Mass Tort” to the doctors present. There were no plaintiffs’ attorneys to lend balance to what she claimed. And the two doctors on the panel are currently consultants to Coloplast, among other mesh makers.
In the changing litigation landscape, both panelists had lost lucrative consulting dollars. According to trial testimony, Dr. Lucente was a preceptor for many doctors in training, including Ethicon, maker of the Prolift mesh for POP which is no longer on the market.
Dr. Cassidenti was working with American Medical Systems as a consultant and trial expert, but AMS was sold to ENDO International, which decided to close down its mesh division, Astora Women’s Health and with it, his preceptorship. See a background story here.
On more than one occasion, Dr. Cassidenti blamed pressure from plaintiffs’ attorneys for closing AMS.
“What can we do to keep products that are very helpful to our patients?” he asked. Currently only Restorelle by Coloplast and Uphold by Boston Scientific remain on the market as a treatment for POP.
“He is loose on his rulings,” said Coloplast’s Floro, referring to federal Judge Joseph Goodwin who is overseeing the MDL in West Virginia. She was referring to some rulings that had gone in the favor of the defense, and some that had not. Of the 20 trials so far over pelvic mesh, defense has won six after juries looked at both sides.
Dr. Cheryl Iglesia from Washington D.C., said she is getting questions from her patients who want to sue and ask who to go to. “What do I say to that patient?” she asked Ms. Floro. “I don’t know what to say. I didn’t know if there was a website that was reputable,” she asked.
Another women in the audience chimed in, “Are any reputable?”
“We do see a decrease in advertising in pelvic mesh litigation. The plaintiffs’ bar has move on to other litigation, Xarelto, talc, Volkswagen,” said Floro, who cynically compared pelvic mesh litigation to consumer fraud class action lawsuits filed over products such as Nutella where claimants can get a coupon for $5 for their trouble since the product was falsely marketed as healthy.
One doctor suggested women were “looking for a payout,” as a reason for the 100,000 plus lawsuits against seven mesh manufacturers. Another doctor said women are coming into her office proudly displaying a check they were awarded as part of mesh litigation.
Cassidenti asked “Do you think when the industry gravy train is over, with they come after the physicians?”
Women who fly across the country to have their mesh removed return to their primary physician and that is a problem, opined another urogynecologist. AUGS is working on removal guidelines so that women no longer have to seek removal experts who live long distance.
Dr. Lucente suggested a woman came to him with pain after a cross country mesh removal odyssey, only to receive a shot and then she was okay.
Dr. Donald Ostergard, one of the founders of AUGS, who was first to suggest to the early adapters that “mesh is not inert,”stood up and asked if anyone know about Boston Scientific and allegations is smuggled counterfeit mesh resin into the U.S. from China when it could no longer buy resin domestically.
The doctors hadn’t hear anything.
“Tell us about it, Don.”
Dr. Ostergard suggested that Boston Science mesh made after 20112 might contain a substandard mesh and that Scotland had stopped selling it, all of it.
“Emotion, Fear and an alarming reaction gets way in front of the facts of science,” suggested Dr. Lucente, comparing mesh to the morcellator medical device that grinds up the uterus and sometimes fibroids masking deadly and aggressive uterine cancers. ###
http://www.meshmedicaldevicenewsdesk.com/augs-mesh-procedures-left-litigation/
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AUGS – Patient Presence Missing from Urogyn Society Meeting
Oct 5, 2016 | Mesh Medical Device Newsdesk
With an emphasis on innovation and advancement in the practice of urogynecology, at the AUGS annual conference of specialists, there were few reminders about the outcomes of, what’s been described as the darkest chapter in women’s health history, that is, the patient presence.
The iconic giant blue bear peering into the Denver Colorado Convention Center was the most photographed image from day one of the annual American Urogynecologic Society (AUGS)Pelvic Floors Disorders Week. (Tweet #PFDWeek)
Tweets were aflutter from the 1,300 in attendance, whether urologists, gynecologists, fellows, surgeons or urogynecologists, a relatively new field combining female pelvic medicine and reconstructive surgery with gynecology to treat pelvic floor disorders in women.
This was the 37th time the society had met to listen, share and learn. Residents, doctors in training, were there to grab a fellowship in this specialty, and young, attractive women in stilettos and young men in neat, new suits, were being interviewed in the lounge areas with hopes of joining the lucrative field of corporate sales or marketing.
Also in attendance were the key opinion leaders (KOL) of AUGS. These are some of the most experienced doctors in this subspecialty, according to the society, and those who shape the face of AUGS. Industry-sponsored education was led by the KOLs who trained other doctors, hoping to bring more into the corporate tent of the largest medical device makers.
Here is the final program.
Monday night the exhibit hall was yet to be set up, but boxes from major medical device manufacturers were waiting to go on display.
CORPORATE SPONSORS
Coloplast room key, Hyatt Regency
At least half of the expenses of this convention were covered by industry, according to AUGS leadership
Sponsorship at the Platinum Level of $75,000 included Allergan, Boston Scientific, Coloplast and Medtronic, Inc.
That premium price would buy you a booth or two in the exhibit hall, premium placement of your company logo and banners.
Available for a price were glossy brochures left on tables in the exhibit hall where you’d eat your industry-supplied lunch, a draped back wall, a coffee cart, water bottles, an aisle sign and charging station. The Wi-Fi access was provided courtesy of Allergan, which was the login password.
Your sponsorship included a logo labeled hotel key card at the nearby Hyatt Regency.
Here are the PFDWeek costs. See the AUGS Exhibitor and Sponsor Guide, and an example of a ceiling banner from Boston Scientific.
Dr. Peter Rosenblatt for BSC
Gold level sponsors paid $50,000 and included Astellas, while the Bronze level sponsors at $10,000 were Caldera Medical, Cogentix Medical, CooperSurgical, Neomedic International and The Prometheus Group.
The $5,000 Copper Level sponsors included Pelvalon, Syneron Caldela and Universal Triumph.
KEY OPINION LEADERS
Not surprisingly, the key opinion leader’s names appear among the top donors to AUGS and include Drs. Andrew Cassidenti and Vincent Lucente.
The generosity is reciprocal – Cassidenti lists Boston Scientific, Consultant; Coloplast, Consultant; as well as a Defense expert witness vaginal mesh litigation.
Dr. Lucente lists Allergan, Speaker and Grant/Research Support; American Medical Systems, Consultant; Coloplast, Consultant; and Medtronic, Consultant. At trial, he’s cited as the $1.7 million consultant for Ethicon.
Ethicon table
Ethicon, a division of Johnson & Johnson has the most defective product lawsuits filed in the U.S., in excess of 45,000, yet its presence here was minimal.
The company has taken off the market its larger TVM (transvaginal mesh) kits for pelvic organ prolapse.
Also missing was the presence of any patient advocates or patients to engage and share with those present. Note* as editor of a website read by many mesh injured, I intentionally kept a low profile, sensing my presence would not be welcome. That theory was later proven true.
Even the few doctors I spoke with, who treat mesh-injured, kept their sentiments to themselves, acknowledging they were in the vast minority.
AUGS generated $5 million in revenue in 2015 and has plans for a new building in Silver Springs, Maryland, and has since 2007 seen an incremental expansion of membership and revenue, up 30% and 38% respectively.
TOPICS
Discussions to be had during the four-day event included a return to native tissue repairs; evaluating common female urological concerns; bladder injuries; advances in laparoscopy and robotic reconstructive pelvic surgery; coding and ultrasound; as well as the coming changes with federal Medicare reimbursement for physicians known as MACRA.
The Best Paper Award went to Dr. Pamela Moalli, MD of the University of Pittsburgh for Regeneration of Vaginal Support Utilizing an ECM Bioscaffold, a discussion of alternatives to polypropylene to support a vaginal floor prolapse. The patented MatriStem ECM by ACell is an extracellular matrix product to repair damaged tissues.
Science of mesh products is ever evolving. Expect robotics to grow and alternatives to polypropylene for implants. Doctors are returning to sacrocolpopexy and native tissue repairs.
An estimated 3.5 million mesh slings have been implanted and approximately one million transvaginal mesh kits. The litigation that’s has emerged as mesh-injuries evolved mean that next to asbestos, this is now the leading mass tort ever filed in this country.
Women report constant and chronic pain and infection, mesh erosion, mesh shrinkage, scar formation, pudendal nerve damage, and autoimmune responses to mesh, among other post-surgical outcomes. One wouldn’t know that because these minimally-invasive procedures have had minimal media coverage.
With all the emphasis on innovation, one could only wonder what influence mesh litigation has had on these doctors individually and the society as a whole.
With more than 100,000 lawsuits filed in the U.S. alone alleging polypropylene mesh is a defective product, what was the current thinking among AUGS members and leadership?
Were the corporate mesh makers – Boston Scientific, Ethicon/ Johnson & Johnson, Caldera Medical, Coloplast among them, still able to cultivate relationships with doctors despite the fact that of the 20 trials conducted so far, the defense had won just six.
Of the 14 mesh-injured women who proved their case at trial, all were awarded compensatory damages and in some cases punitive damages intended to punish a company.
Jurors made those decisions, presumably after listening to evidence from both sides.
What did the doctors here know about that and how would the society address those women with life-altering mesh complications?
I assumed most physicians are intelligent, thoughtful people who entered medicine to help others.
I was there with opened eyes and ears to take the temperate of the society as a whole and to learn what was on the horizon for the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP), considering all that has recently transpired and continues to evolve. ###
http://www.meshmedicaldevicenewsdesk.com/augs-patient-presence-missing-urogyn-society-meeting/
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ProteGen – The First Mesh, a 20 Year History
Oct 3, 2016 | Mesh Medical Device Newsdesk
Of the sixty or so pelvic meshes that were or currently are on the market in the United States you may not have heard of the ProteGen mesh, a model designed and manufactured by Boston Scientific. The ProteGen was the first transvaginal mesh approved in the U.S. in November 1996.
It has the distinction of being the “grandmother” or prototype that served as a model for most of the permanently implanted pelvic meshes that followed.
Boston Scientific had beat their competitors in terms of marketing efforts, which were put into play shortly after forecasters predicted the aging baby boomers would be in need of pelvic mesh support to treat prolapse and incontinence post surgery.
In 1996, ProteGen began marketing after being cleared through the Food and Drug Administration’s (FDA) 510(k) premarket notification process as manufacturers file to seek an approval to market and sell, not based on safety or efficacy. The clearance number is#K963226.
The “K” in the clearance number stands for the K in the 510K FDA code that allows for clearance without clinical trials after an exchange of paperwork, the naming of a “predicate device” that is the “substantial equivalent” of the new device, a few thousand dollars and a wait of about 90 days.
The entire process is a significant gesture of the device industry and relies on its honesty and integrity. From what we’ve learned about the thinking of device manufacturers and their rush to get the product on the market, the confidence in the quality of their product is not necessarily warranted.
After November 1996, a flood of new competitor devices made it to market. Ethicon’s Tension Free Transvaginal Tape (TVT) was cleared by the FDA in January 1998 naming ProteGen as a predicate device. The TVT-O (obturator) was also cleared for market based on the ProteGen model.
Altogether dozens of devices named the ProteGen as a predicate. If they were not directly linked, they were predicated on some other devices that were based on ProteGen. Mentor, Ethicon,American Medical Systems, Gyne Ideas, Tyco, Caldera all either named ProteGen as their direct or indirect predicate (substantial equivalent).
All of these pelvic mesh implants were approved through the fast-track 510(k) process with the knowledge that “No performance standards applicable to surgical mesh have been established by the FDA,” as was stated in the 510(k) Summary for the In-Sling. As is the lack of a standardized process for approval isn’t concerning enough, the ProteGen sling, was recalled from the market by Boston Scientific on March 17, 1999 for some troublesome complications.
The reason stated – “The use of the ProteGen in the treatment of female urinary incontinence is associated with a higher rate than expected of vaginal erosion and dehiscence and does not appear to function as intended.” Dehiscence is a wound rupture at a surgical incision. In short, the mesh was recalled after proving to be defective in ways that were harmful to patients.
This recall should have been a huge red flag for the FDA, who’s job through their approval process is keeping Americans safe by ensuring that the process. If a predicate device is defective, those that follow should be carefully inspected for the same issues.
Sort of like the 1977 recall of the Ford Pinto because of its tendency to erupt into fuel-tank fires in rear end collisions. Imagine if there was a family of automobiles based on the Pinto design? Would they be subject to a recall or at least a review to see if they share the same safety deficiencies as the Pinto?
But ProteGen did not set off a different review process for pelvic mesh devices. Even though it was recalled due to it’s harmful effects, there is was no effort within the FDA to more thoroughly inspect the medical devices that were developed based as “substantial equivalents” to the ProteGen.
Even though the ProteGen is history, most of its entire family of successor meshes remain on the market and we know from more than 100-thousand lawsuits what has happened.
For the same reasons that mesh manufacturers are being shunned for discreditable marketing and manufacturing practices, the FDA needs to share in some of the blame.
In 2011, the Institute of Medicine said the now 40-year- old 510(k) approval process is obsolete and needs to be revised in order to provide the assurance of safety and effectiveness of medical devices before they are approved to be used by the public. The Protogen is a perfect example of the need for change.
http://www.meshmedicaldevicenewsdesk.com/protegen-first-mesh-20-year-history/
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