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Ethicon Media Monitoring 3/25/2019
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Phila. Judge Declines to Bounce Colleague From Pelvic Mesh Trials
Mar 22, 2019 | Legal Intelligencer
By Max Mitchell
Johnson & Johnson has lost its bid to have Philadelphia Judge Kenneth Powell removed from handling any future pelvic mesh trials in Philadelphia. -
Divvying the Dollars- Common Benefit Firm Winners and Objectors
Mar 23, 2019 | Mesh Medical Device Newsdesk
By Jane Akre
While billions of dollars have gone to settle pelvic mesh cases, some law firms are still wrangling over how the common benefit funds will be distributed. -
With imperfect data, FDA turns to panel for way forward on breast implants
Mar 22, 2019 | MedTech Dive
By Maria Rachal
FDA Thursday afternoon unveiled questions for its General and Plastic Surgery Devices Panel, covering broad categories including: how to best characterize and address breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and breast implant illness... -
FDA Flags Surgical Staplers after Reports of Medical Malfunctions
Mar 22, 2019 | Med News 365
By Vanessa Bremen
The U.S. Food and Drug Administration has just flagged a common medical device—surgical staplers and implantable staples—because of a heightened risk associated with their use in medical procedures.
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Phila. Judge Declines to Bounce Colleague From Pelvic Mesh Trials
Mar 22, 2019 | Legal Intelligencer
By Max Mitchell
Johnson & Johnson has lost its bid to have Philadelphia Judge Kenneth Powell removed from handling any future pelvic mesh trials in Philadelphia.
On Friday, the judge overseeing Philadelphia’s Complex Litigation Center declined to grant a motion by J&J subsidiary Ethicon, which had requested that Powell be barred from handling pelvic mesh trials because his mother is pursuing a lawsuit against another J&J subsidiary over the blood thinner Xarelto. The one-sentence order, entered by supervising Judge Arnold New, did not explain the reasoning behind the decision.
A spokeswoman for Ethicon, which is the primary defendant in nearly 100 pelvic mesh cases pending in Philadelphia, said in an emailed statement, “We’re disappointed by the decision, but we appreciate Judge New’s consideration of this matter.”
Kline & Specter attorney Shanin Specter, a lead attorney representing the plaintiffs in the consolidated pelvic mesh litigation, said in an emailed statement that the ruling was in line with decisions from other members of the judiciary, including the seven-member Pennsylvania Supreme Court, which denied a similar motion that Ethicon filed earlier in the month.
“That’s now 10 judges or justices who have refused Johnson & Johnson’s efforts to run the court system through their own brand of judicial selection,” he said. “But unfortunately I expect J&J to be undeterred and to foment more mischief. Meanwhile, we’ll just keep trying these important cases one at a time to whomever is assigned.”
Ethicon’s motions to have Powell removed come as juries in Philadelphia have repeatedly awarded plaintiffs multimillion-dollar verdicts over claims that the company failed to adequately warn about the dangers of pelvic mesh implants. Of those cases, Powell oversaw Emmett v. Ethicon, which ended in a $41 million verdict in January, and Carlino v. Ethicon, which resulted in a $13.5 million award in early 2016.
In its request to have Powell removed from hearing pelvic mesh cases, Ethicon contended that, not only was Powell’s mother pursuing a case against another J&J subsidiary, he also failed to properly disclose the lawsuit, or allow for full briefing on the issue. Citing the Pennsylvania Code of Judicial Conduct, Ethicon said that judges need to avoid conduct that “creates the appearance of impropriety,” and that there had been “a history of non-disclosure, of commentary and of rulings that create the appearance of bias and warrant recusal.”
The plaintiffs had responded by saying J&J was a “bully” and “a mass tortfeasor,” and the efforts to get Powell removed from cases “was beyond the bounds of fair advocacy.”
The dispute bares at least a passing resemblance to a situation that arose several years ago involving another judge who failed to disclose a close family member’s ties to a party in a case he oversaw. That judge was Allan Tereshko, and in 2011 he dismissed an insurance dispute without first disclosing to the parties that his wife was working in Post & Schell’s professional liability department at the time that Post & Schell was representing the defendant.
That situation resulted in a warning from a Superior Court majority, as well as a scorching concurring opinion from Superior Court Anne Lazarus, who said Tereshko not only prejudiced the parties but he also “failed in his professional responsibility as set forth in the Code of Judicial Conduct.” Tereshko resigned his position as a supervising judge a few days later.
Ethics attorneys who spoke with The Legal said there appeared to be possible similarities between the situations, but the issues surrounding when a judge needs to disclose or recuse are very fact-specific.
University of Pittsburgh School of Law professor Arthur Hellman said not immediately disclosing the lawsuit of a family member could be problematic.
“It’s not one of those things where I could say it’s too speculative, or too far from the realm of an arguable conflict,” he said.
Yale Law School lecturer Lawrence Fox, who said he could not comment about the specifics of the pelvic mesh situation without knowing all the details of the case, said that in general it is the judge’s responsibility to bring any potential issues to the parties’ attention.
“The emphasis is on disclosure,” Fox said. “Even if I think I shouldn’t recuse I should tell the parties what the issue is because they might come up with another argument.”
However, regarding the actual alleged conflict, Hellman said there appeared to be sufficient distance between the pelvic mesh cases Powell has tried and his mother’s lawsuit to make the recusal argument a “stretch.” He noted that even though both companies at issue are J&J subsidiaries there are corporate distinctions between the companies. He also said it did not appear that any of Powell’s rulings could affect either the Xarelto litigation broadly, or Powell’s mother’s case specifically.
“You would have to find some overlapping issues to say her interests would be affected to trigger an obligation to recuse,” Hellman said.
https://www.law.com/thelegalintelligencer/2019/03/22/phila-judge-declines-to-bounce-colleague-from-pelvic-mesh-trials/
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Divvying the Dollars- Common Benefit Firm Winners and Objectors
Mar 23, 2019 | Mesh Medical Device Newsdesk
By Jane Akre
While billions of dollars have gone to settle pelvic mesh cases, some law firms are still wrangling over how the common benefit funds will be distributed.
The answer can mean millions to an individual law firm.
There is no easy way to talk about money in litigation.
Plaintiffs feel they didn’t settle for enough. In the case of pelvic mesh, many did not. Sometimes lawyers cannot bring a case to a close and drop the client, losing out on any reimbursement of the firm’s costs and fees.
Then there is the other side of the coin – the millions of dollars in proceeds from pelvic mesh litigation and settlements waiting to be divided.
Common Benefit Fund
Lawyers spend years devoting themselves almost exclusively to an MDL. It is grueling, exhaustive work that requires years of dedication.
In the case of pelvic mesh, the multidistrict litigation (MDL) was formed in Charleston, West Virginia in early 2012 naming seven mesh manufacturers. It eventually grew to consolidate 104,836 plaintiffs. Over the last seven years, tens of thousands of cases have settled or been dropped.
Eventually settlements and verdicts would total $7 billion. That number is still growing.
The Common Benefit Fund (CBF) is pooled monies – representing 5% of any settlement or verdict – meant to compensate attorneys for the cost outlay and the work performed for the common benefit of all of the plaintiffs.
What is the work performed? In all, more than 199 million pages have been produced across the pelvic mesh MDL including more than 200 individual and 30 corporate depositions. Key opinion leader physicians were deposed as were medical, scientific and biomaterials experts. The theories related to defective design of the TVM (transvaginal mesh) devices required knowledge of anatomy, medicine, scientific principles, and literature surrounding synthetic and biologic surgical medical devices.
The plaintiffs’ lawyers had to describe had mesh eroded in the body and caused chronic and excessive foreign body reaction. The inadequate pore size had to be explained, as did mechanical instability, scar tissue formation, and the mesh arm “sawing” as the mesh contracted.
Many of the plaintiffs’ experts were in Europe necessitating travel and expenses there. Costs also including the housing of discovery to make it searchable and accessible. Plaintiffs’ firms had to prepare bellwether and other cases for trial and see them through to a verdict.
There were 52 general plaintiffs’ experts. Plaintiffs’s firms handled post-verdict motions, directed verdicts and appeals.
In the case of pelvic mesh, in all, 94 law firms submitted more than 900,000 hours of time for common benefit consideration along with their hourly rate, to bring their compensation/reimbursements into the millions.
The Deciders
In January 2016, the pretrial order establishing the criteria for applying to the MDL fund was established. The order appointed nine individuals as the Common Benefit Fee and Cost Committee. The Honorable Daniel J. Stack, retired, was appointed as the External Review specialist.
The party of nine includes Renee Baggett, Henry Garrard- Chair, Yvonne Flaherty, Riley Burnett, Carl Frankovitch, Thomas Cartmell, Clayton Clark, Joseph Rice, and William Mckee.
Sixty-one attorneys from law firms across the country make up the Plaintiffs’ Steering Committee (PSC) who worked to develop litigation strategy and theories of liability, depose experts and “absorb massive litigation costs.”
Those in leadership positions also find themselves on the receiving end of some of the largest dollar distributions.
So far the defendants have made approximately $7 billion in payments to settle cases or the result of verdicts, that has resulted in $366.5 million in payments into the CBF. That number ultimately may exceed $550 million.
Distributing the Dollars
PreTrial Order #332 issued March 12, outlines how the money will be distributed.
Of the 94 firms who submitted more than 900,000 hours of time for common benefit consideration, the FCC has reduced the recognized hours to 679,191.20. The FCC has communicated to each applicant firm whether their hours will be recognized or reduced.
Eight firms presented an argument to the FCC’s final Written Recommendation while 24 firms objected the FCC’s Preliminary Written Recommendation. Twenty-seven firms met with the FCC in-person to further discuss their hours.
Of the eight firms, many did work primarily in the State court of New Jersey and based their objection in part on an agreement entered between MDL leadership and certain New Jersey counsel.
The objectors wanted all of their time to be considered common benefit because they felt the FCC was not accurately reflecting the value of their work, especially considering the successful court outcomes in Ethicon litigation.
The Objectors
Among the four firms that continue to object to the FCC’s Final Written Recommendation include firms that did not have members on the executive committees of the MDL. They include:
Anderson Law Offices – Ben Anderson was in the courtroom in Budke v Ethicon, Bellew v Ethicon, Lewis v. Ethicon, in Charleston, WV. Judge Daniel Stack did agree to increase of 0.1142858%
Bernstein Liebhard – Judge Stack agreed to an increase of 0.1285715%.
Kline & Specter – The Philadelphia firm has had a series of successful outcomes for its plaintiffs in Ethicon litigation of more than $140 million. Judge Stack recommended no changes in the amount allocated for common benefit fees.
Adam Slater, Mazie Slater Katz Freeman
Mazie Slater Katz & Freeman – This New Jersey firm has also conducted a series of plaintiff won chases against Ethicon. They argue the early cases tried in New Jersey (Linda Gross v. Ethicon), as well as one expert developed by Mr. Slater (Anne Weber) were almost solely responsible for the success of all of the MDLs. Yet Judge Stack recommended no change to the amount allocated for common benefit fees.
The Honorable Judge Stack writes that not all hours are equal, and that time to review a document should be compensated at a different rate than a deposition. He adds citing Diet Drugs, 2003 WL 2003 WL 21641958 at *10-*11.
“with so much money at stake and so much time invested by skilled attorneys on valuable common benefit work, it is not surprising that disputes exist concerning the proper method and dollar amount of the individual allocations. We emphasize, however, that the allocation of fees is not an exact science.”
Henry Garrard had criticized Kline & Specters’ noting the settlements were “puny.” The Philadelphia law firm argued that the 5% common benefit fund should be partially returned to plaintiffs. Garrard called Kline & Specter’s criticisms “blatant hypocrisy,” reports The Legal Intelligencer.
Those At The Top
Again those in executive and fee committees appear to be the rainmakers for their law firms. They include:
Blasingame, Burch, Garrard & Ashley – Henry Garrard, firm partner helped start the pelvic mesh litigation and secured high ranking spots in the Plaintiffs’ Steering Committee for all TVM MDLs. He heads the fee committee that recommends an allocation of $56.6 million plus reimbursement of the $350,000 in assessments and $9.5 million in expenses.
Motley Rice – was very active in the committee appointments from the beginning with patner Fred Thompson on the Steering and Executive Committees. The Fee Committee recommends an allocation of $49 million, plus reimbursement of the firms $350,000 and expenses in the $2.9 range.
Clark, Love Hutson – Clayton Clark was co-lead counsel for Boston scientific and is a member of the executive committee and the Plaintiffs’ Steering Committee. The Fee Committee recommends an allocation of $45.5 million, plus reimbursement of $350,000 in assessments and reimbursement of $4.2 in expenses.
Wagstaff & Cartmell – Early on the firm worked in all TVM litigation with Tom Cartmell on the Executive, and Plaintiffs’ Steering Committees. The Fee Committee recommends an allocation of $38.5 million plus reimbursement of the firms $350,000 and $1.6 million in expenses reimbursed.
Aylstock, Witkin, Kries & Overholtz – the fee committee recommends an allocation of $27million plus reimbursement ($350,000 assessment) and $1.1 million in expenses.
While the objectors were reimbursed:
Kline & Specter – Partner Lee Balefsky is a member of the Plaintiffs’ Steering committee. The firm tried most of its cases in Pennsylvania State Court and won in excess of $140 million for the plaintiffs. The Fee Committee recognized an allocation of $3.7 million, plus reimbursement of the firms $350,000 in assessments and reimbursement of $667 thousand in expenses.
Mazie Slater Katz & Freeman – In 2013, the New Jersey firm broke new ground by successfully trying Linda Gross v. Ethicon with an $11.1 million verdict. It has had a series of successful verdicts in New Jersey since then. The fee committee recommends an allocation of $6 millionand reimbursement of $1.8 million in expenses.
Anderson Law – $7.2 million in fees plus reimbursement of assessments ($350k) and expenses of $666,993.
Judge Daniel Stack writes, “Arguments that there were different “rules” for the FCC members and other applicant firms are simply without merit and factually incorrect.”
According to PTO #332, all objections need to be filed before March 26.
https://www.meshmedicaldevicenewsdesk.com/divvying-the-dollars-common-benefit-firm-winners-and-objectors/
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With imperfect data, FDA turns to panel for way forward on breast implants
Mar 22, 2019 | MedTech Dive
By Maria Rachal
Dive Brief:
· FDA Thursday afternoon unveiled questions for its General and Plastic Surgery Devices Panel, covering broad categories including: how to best characterize and address breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and breast implant illness; how to leverage registries and communicate risks to patients; and the benefits and risks of incorporating mesh for breast reconstruction and MRI screens to catch implant rupture.
· The agency also shed light on methods and findings from data collected by the four approved manufacturers, adding depth to BIA-ALCL medical device report data FDA teased last month and context to the warning letters issued this week to Mentor and Sientra. The FDA repeatedly noted shortcomings of the MDR system and manufacturer study inconsistencies have hindered the ability to draw conclusions. It said that calculating the percentage of breast implant recipients who develop BIA-ALCL would be "impossible" because there is no definitive accounting of breast implant sales worldwide.
· Building on its pledge last week to better scrutinize device materials' biocompatibility, FDA presented evidence on delayed onset symptoms that it says may be tied to silicone implants. While FDA has not asserted a clear link between breast implants and reported adverse events, the agency did seem receptive to formally acknowledging and defining breast implant illness, a term it says originated within patient communities, particularly on social media.
Dive Insight:
As it aims to get a handle on illnesses tied to breast implants, FDA acknowledged the limitations of its own adverse event reporting system.
"MDR is a method of passive surveillance, because it accepts reports, but does not actively interview every patient and manufacturer for information," the agency noted.
Still, the agency indicated mounting evidence of adverse events among breast implant recipients.
"At the present time, there is not sufficient evidence to show an association between breast implants and rheumatologic or connective tissue disease diagnoses," the briefing said. "However, there are numerous breast implant patients convening on social media to discuss a wide variety of symptoms that they are experiencing —symptoms which may or may not meet the diagnostic criteria to be categorized as a disease."
Citing the ASIA theory ("Autoimmune/Autoinflammatory Syndrome Induced by Adjuvants"), wherein substances like aluminum salts, mineral oils and metals can enhance antigen-specific immune responses, FDA also talked about possible complications stemming from the implants' silicone material, for which some patients may be pre-disposed to allergic reaction. The agency added that the average time for these symptoms to present is between four and 10 years after implantation.
"Despite overlap in clinical manifestations, conflicting research outcomes have failed to provide definitive evidence that silicone breast implants are associated with the development of a defined autoimmune or connective tissue disease," FDA wrote, with emphasis on 'defined.'
In its two-day meeting at its Silver Spring, Maryland headquarters March 25-26, FDA is looking for guidance in the following categories:
Best use of registries. FDA wants to make the most of its registries, which include the BIA-ALCL-specific PROFILE registry, as well as the newer National Breast Implant Registry (NBIR), which tracks other adverse outcomes. The agency wants the panel to prioritize the most important types of data to collect, which in turn can guide the types of doctors tapped to enter data. FDA acknowledged critics of the registries, who say that access to data entry for certain physicians, and to data analysis by the public, is too limited. But FDA said it hopes the panel will weigh these concerns against the benefits of consistency and quality that may come from narrowing access. The agency also opened the possibility for mandating stricter registry engagement, asking the panel whether mandatory reporting to registries could be a positive.
Characterizing BIA-ALCL incidence and risk factors. FDA was clear throughout its briefing documents that its MDR data is incomplete and imperfect, making it challenging for the agency to pointedly characterize risk of BIA-ALCL development to patients. MDRs sometimes note implants surface and fill and time from implant to diagnosis, but reports are inconsistent.
To improve in that realm, FDA wants the panel to specify what data manufacturers should be required to report on breast implant placements so it can better track how certain breast implant characteristics impact rate of BIA-ALCL.
Regulators also want the panel of experts to consider whether the benefit/risk profile of breast implants differs by texture. FDA noted that of the 457 unique BIA-ALCL MDRs it reported receiving as of Sept. 30, 2018, 334 noted surface type, with 310 characterized as textured and 24 as smooth.
Addressing breast implant illness. FDA notes that the concept and naming of breast implant illness (BII) originated not from the agency nor from the scientific community, but from patient communities and voluntary reporters. Similar to the communities of women who received Essure or transvaginal mesh, FDA acknowledged that breast implant patients who have experienced adverse outcomes have built networks online, particularly using social media.
Now, the agency is looking to more formally define the term. FDA laid out more than 80 medical outcomes that have been associated with breast implant illness MDRs, with the top five being fatigue, brain fog, rash, joint pain and memory loss.
FDA's more specific questions include how to characterize relative risk of developing BII symptoms compared to the general population, what research questions should be explored, how symptom-presenting patients should be evaluated and how that information should be shared, and what post-operative data should be collected on patients who have implants removed as a result of BII.
FDA also wants to consider how it can use social media, as well as "artificial intelligence, text mining, mobile apps, and digital health," to collect and analyze data on BII symptoms.
Using surgical mesh for breast reconstruction. Among FDA's list of things that women may not know about breast implants, it notes many patients may not be aware that the majority of breast reconstructions involve the use of a surgical mesh device in conjunction with the breast implant itself. The use of hernia mesh or transvaginal mesh for pelvic organ prolapse or stress urinary incontinence has been a separate controversy FDA has addressed this year.
The American Society of Plastic Surgeons reports about 175,000 patients each year undergo reduction mammaplasty and mastopexy each year, otherwise known as breast reduction and breast lift, and that while FDA has not indicated synthetic and biological mesh products for use in these procedures, the agency has noticed "emerging use" of the devices in medical literature.
FDA said that a number of factors can affect the outcomes of mesh in breast reconstruction, like implant type, whether the mastectomy was skin-sparing or nipple-sparing, whether the reconstruction was immediate or delayed, whether a tissue expander is used prior to an implant, and where and how the implant is placed.
"Designing a clinical trial in support of a potential marketing application may require identifying specific patient populations and surgical procedures that demonstrate an appropriate balance of safety and effectiveness," FDA said of future incorporation of mesh in breast procedures.
FDA is asking the panel to help characterize how benefits and risks of mesh ought to be weighed, and whether a registry is needed for breast implant patients who also receive mesh.
Recommendations for MRI screening for implant rupture. FDA said that while mammography, ultrasonography and computed tomography have all been used in attempts to detect silent rupture of silicone gel-filled breast implants, MRI has proved the most effective. A 2006 advisory committee recommended an MRI screen at three years and biennially thereafter for all approved breast implants. FDA said it has tried to track whether that labeling is worthwhile by analyzing rupture detection rates in post-approval study data, but that differences in data collection methods across manufacturers makes meaningful conclusions difficult. FDA also acknowledged it must consider concerns raised surrounding cost and reimbursement of MRI screens.
American College of Radiology guidelines on breast implant imaging, updated in 2018, said that given a lack of consensus on whether ruptured silicone implants require surgery in asymptomatic patients, breast MRI ought not be indicated for implant evaluation in asymptomatic women at any age.
"Due to the differences in the methods in which ruptures were detected and confirmed, the types of data that were collected, length and frequency of patient follow-up, and the methods for analyzing and presenting the data greatly limited the comparisons that can be made between manufacturers," the briefing document said.
Ultimately, FDA wants to know whether it should continue to recommend MRI screening, and if so, what evidence supports its benefit/risk profile. It also wants to know if alternative screening methods can or should be used.
Communicating risks and benefits to patients. FDA acknowledged patients may not know breast implants are not intended to be lifetime devices, and that over time, risk of local complications and adverse events rises, which could lead to implant removal. Rupture rates have been shown to increase four to six years after implant placement, FDA said. Other possible complications to be aware of include capsular contracture, re-operation, removal, and implant rupture, as well as breast pain, wrinkling, asymmetry, scarring and infection.
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FDA Flags Surgical Staplers after Reports of Medical Malfunctions
Mar 22, 2019 | Med News 365
By Vanessa Bremen
The U.S. Food and Drug Administration has just flagged a common medical device—surgical staplers and implantable staples—because of a heightened risk associated with their use in medical procedures.
The FDA issued its warning in a “Letter to Health Care Providers.” In it, the federal agency is alerting doctors and health care providers of an alarming increase in reports of malfunction when using surgical staplers and implantable surgical staplers. In its warning, the FDA also published recommendations for how manufacturers can improve the labeling of surgical staples and stapler devices to help health care providers use the devices more properly and effectively, such as choosing the correct size of staple for the type of procedure and patient tissue. The labeling recommendations also suggest that health care providers consider alternative options to surgical stapling in cases where the patient has a predisposition of bleeding or if the patient has swollen tissues.
The FDA also highlighted its own recommendations to help reduce the risks of these devices, and they outline the agency’s plans to address the safety of the devices over the coming months. These plans include creating a public advisory committee to analyze the path for medical device manufacturers to bring their surgical staples and staplers to market, and whether this current pathway has the appropriate safety and review checks.
Thousands of Reports of Device Malfunction.
The FDA’s warning reports that it has received more than 41,000 risk reports for surgical staplers and implantable staples since January 2011. These complaints, called “medical device reports,” include more than 90,000 serious injuries, more than 32,000 reports of device malfunction, and 366 patient deaths from using these devices.
The agency outlined the types of problems reported from surgical staplers and staples. The most common issues reported range from staplers misfiring and difficulty of firing staples, to malformation of staples and opening of the suture line after implantation. The complaints reported also included an issue with the staples being misapplied, or when the health care professional implants the staples into the incorrect tissue, as well as cases of using the wrong size of staple for the patient’s tissue.
The FDA states that these problems with the devices can have significant impacts on the health and safety of patients. Health risks include prolonged surgical procedures and risk of tearing of internal organs and tissues. The malfunction of surgical staplers and implantable staples have, in some cases, required additional, unplanned medical procedures; these, in turn, could lead to other medical complications including bleeding, tissue and organ tearing, increased risk of cancer, and even death.
And this is not the first time that the FDA has warned about the risks associated with surgical staplers and implantable staples. The FDA has been reviewing the risks of these devices for years and has issued previous communications about the potential risks of their use.
Prevalent Use of Surgical Staplers and Implantable Staples.
Surgical staplers and staples are widely used across many types of surgeries and medical procedures. These procedures range from gynecologic and gastrointestinal procedures, to procedures creating connections between organs and body tissues. Implantable staples and surgical staplers also facilitate resection procedures, or when surgeons remove part of a patient’s organ.
One benefit of surgical staplers and staples is a quicker operating time or the patient: the devices help make surgical procedure time quicker than it would be with traditional manual suturing. Implantable staples also have a lower risk of infection and maintain a strong wound closure to help support the patient’s recovery.
Quick Market Access for Device Manufacturers.
This warning letter from the FDA has highlighted the quick and easy access to the market that manufacturers of surgical staplers enjoy. Because these devices are categorized as only “Class I” medical devices, they do not require any regulatory submissions to the FDA before they can be sold on the market to health care professionals. This means that there is no mandatory FDA review and approval before these surgical staplers are used in medical procedures. (On the other hand, surgical staples are classified under the higher “Class II” of medical devices, and therefore they do require the FDA’s review before they can go to market.)
The Investigation is Ongoing.
In response to its new warning, the FDA emphasized that reporting potential health risks to the pubic is essential to the agency’s public health mission. The chief medical officer of the FDA Center for Devices and Radiological Health said that the agency also plans to make its own process of addressing medical device risks more efficient, modernizing its procedures so that it can address device safety issues more quickly. This includes sharing information and analysis of medical device benefits and risks to both the public and to health care providers.
The FDA also emphasized that it is a top priority of the agency to improve the safety of surgical staplers and implantable staples. Meanwhile, its investigation into surgical staplers and staples is ongoing.
https://mednews365.com/fda-flags-surgical-staplers-after-reports-of-medical-malfunctions/
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