Thousands of Reports of Breast Implant Illness Spur FDA Review

The New York Times

March 20, 2019

By Denise Grady and Roni Caryn Rabin


Reports from thousands of women that breast implants are causing problems like debilitating joint pain and fatigue, claims long dismissed by the medical profession, are receiving new attention from the Food and Drug Administration and researchers.


This may be a long-awaited moment of validation for tens of thousands of women who have been brushed off as neurotic, looking to cash in on lawsuits or just victims of chance who coincidentally became ill while having implants.


The FDA has begun to re-examine questions about implant safety that have long been disputed by doctors and implant manufacturers, and that most consumers thought had been resolved a decade or so ago.


Millions of women have implants, which are silicone sacs filled with either salt water or silicone gel, used to enlarge the breasts cosmetically or to rebuild them after a mastectomy for breast cancer.


On Tuesday, the agency warned two makers of breast implants that they had failed to conduct adequate long-term studies of the devices effects on womens health. Those studies were mandated as a condition of approving the implants, and the agency cautioned that the devices could be taken off the market if the research wasnt properly carried out.


The agency also issued a statement on Friday that applied to a broad array of medical devices, acknowledging that implanted devices may make some people sick. A growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices, the agency said. Those effects can include inflammatory reactions and tissue changes causing pain and other symptoms that may interfere with their quality of life.


The FDA said it was gathering information to fill information gaps in the science to further our understanding of medical device materials and improve the safety of devices for patients. Silicone, used in implants, is one of the materials under scrutiny.


And next week, the agency will hold a two-day meeting about breast implants, hearing from researchers, patient advocacy groups and manufacturers.


One problem to be discussed is an uncommon cancer of the immune system called anaplastic large cell lymphoma, which has been detected so far in 457 women with breast implants, according to the FDA Removing the implants usually eliminates the disease, but some women have also needed chemotherapy, and 17 deaths from the cancer have been reported worldwide.


Nearly all the lymphoma cases have occurred in women who had implants with a textured surface, rather than a smooth one. Textured implants made by Allergan, a major manufacturer, were taken off the market in Europe in December. Smooth implants are used more often than textured ones in the United States.


Another focus of the conference will be breast implant illness, which encompasses disorders that may involve the immune system and can cause muscle pain, fatigue, weakness, cognitive difficulties and other debilitating symptoms. Some ailments fall into a category called connective tissue disease, which includes lupus, rheumatoid arthritis and other serious autoimmune diseases.


The FDA website says the agency has not detected any association between silicone gel-filled breast implants and connective tissue disease. But it adds, In order to rule out these and other complications, studies would need to be larger and longer than these conducted so far.


The new warnings are of potential concern to millions of women with implants. About 400,000 women in the United States get breast implants every year, including 300,000 for cosmetic reasons and 100,000 for reconstruction after mastectomies performed to treat or prevent breast cancer. Worldwide, about 10 million women have breast implants.


The FDAs new focus on implants is a testament to the power of patient activism in the age of social media, as sick women frustrated by their doctors lack of answers sought information online, found other patients with similar complaints and banded together to demand regulatory action. One Facebook group has nearly 70,000 members, according to its founder, Nicole Daruda, a Vancouver Island woman who felt well when she got implants in 2005 for reconstruction after cancer surgery, but soon became so ill she had to stop working.


Ms. Daruda had them removed in 2013, and said most, but not all, of her symptoms have lessened.


Another patient activist, Jamee Cook, now 41, had implant surgery for cosmetic reasons when she was 21. Over the next few years she developed so many health problems, including fatigue, memory lapses, migraines and numbness in her hands, that she had to quit her job as a paramedic.


After having the implants removed in 2015, she said, her health has improved. Though she still has some bad days, Ms. Cook said, Its been like a 180.


Silicone-filled breast implants were first marketed in the United States in the 1960s. Over the next few decades, reports of illness emerged. In 1992, silicone implants were banned, except for reconstruction after mastectomy or to replace a previous implant, and then only in clinical trials.


A flood of lawsuits followed.


Studies conducted afterward generally found no link to connective tissue disease, but a few did suggest a connection. In 1999, the Institute of Medicine, then part of the National Academy of Sciences, concluded that overall, there was no evidence that breast implants caused connective tissue disease, cancer, immune disorders or other ailments.


In 2006, silicone implants came back on the market. But manufacturers were required to follow large numbers of women for seven to 10 years, as a condition for FDA approval. Deficiencies in the studies have now prompted the agency to send warning letters to two of the four companies approved to market breast implants in the United States.


One warning letter, sent to the manufacturer Sientra, of Santa Barbara, Calif. on Tuesday, said the company had not kept enough patients in its study of an implant approved in 2012, and warned that if the follow-up monitoring did not improve, the agency could withdraw approval of the implant, effectively taking it off the market.


Rosalyn dIncelli, vice president of clinical and medical affairs for Sientra, said the company tries to retain patients in follow-up studies by compensating them, contacting them several times a year through email, phone calls, letters and postcards, and transferring them to doctors in more convenient locations. But she said that patients work obligations, child care, lack of transportation and other issues often present obstacles.


We are aware of and take this matter seriously, Ms. DIncelli said, adding that the company will respond to the FDA about corrective measures it plans to take. Patient safety, ensuring long-term safety and effectiveness of our devices and complying with FDAs requirements are our highest priority.


Its stock price dropped a little more than 4% on the FDA news.


Last September, the Securities and Exchange Commission accused its former chief executive, Hani Zeini, of concealing damaging information about the manufacturer of its implants before closing a $60 million stock offering in 2015. The Brazilian manufacturer had had a certificate of compliance required for selling in the European Union suspended. Sientra said its issue with the SEC had been resolved.


The other letter went to Mentor Worldwide, owned by Johnson & Johnson and based in Irvine, Calif. The FDA said the company had not enrolled enough patients in a study of its MemoryShape implant, approved in 2013, and also threatened to rescind approval for the product. Withdrawing approval for a medical device is time-consuming and rarely occurs.


Mindy Tinsley, a spokeswoman for Mentor, said the company was disappointed by the FDAs decision to issue a warning letter despite our good faith efforts to address post-approval study requirements. She said Mentor notified the FDA last year that it would fall short of study enrollment targets because of changes in consumer preferences, but did not hear back. J&Js stock remained unaffected on Tuesday.


According to the FDA, the other two manufacturers whose breast implants are approved in the United States are Allergan and Ideal Implant, which did not receive warning letters on Tuesday. But their implants have also drawn some illness-related complaints from women.


Plastic surgeons and implant manufacturers often say breast implants are the most intensely studied of all medical devices. But critics and patient advocates say most studies done to date are flawed.


When plastic surgeons tell women that this is the most studied medical device in the world, women assume that means they are proven safe, said Diana Zuckerman, president of the National Center for Health Research in Washington, D.C., who has been advising advocates for patients with implant-related illness. But, we still dont know what percentage of women become seriously ill from their breast implants. We still dont know why some women get sick right away, some get sick years later and some never get sick.


Dr. Zuckerman, trained in psychology and epidemiology, will speak at the FDA meeting next week. She wrote a 40-page analysis of breast implant studies, and found that most had not tracked long-term outcomes, or had lost too many participants. In addition, she said, the studies focused only on diseases with specific diagnoses, while ignoring symptoms like joint pain and chronic fatigue. And they were generally too small to detect rare diseases, and were funded by implant manufacturers or plastic surgery associations that had a stake in the outcomes.


Newer studies looking at long-term outcomes have found disproportionately high rates of some uncommon chronic diseases among women with implants, though these studies show only associations and do not prove a cause-and-effect relationship.


Plastic surgeons at M.D. Anderson Cancer Center in Houston who looked at the long-term outcomes of 99,993 women with silicone implants reported finding they had six, seven and eight times the normal population rates of rheumatoid arthritis, scleroderma (a connective tissue disease) and Sjogren syndrome (an autoimmune disorder), all of which are relatively rare diseases.


An author of the study, Dr. Mark Clemens, cautioned that it did not prove cause and effect, and said in an interview, The overarching message is that breast implants are reasonably safe and have high patient satisfaction, but also have complications that patients should be made aware of.


Critics said the study, published in Annals of Surgery in September, did not adjust for underlying differences between women with and without implants, and that the data, drawn from the FDAs own database, was flawed because of high dropout rates.


All the evidence we have to date is that implants are safe, said Dr. Amy S. Colwell, a plastic surgeon at Massachusetts General Hospital in Boston who wrote an editorial criticizing the study, and who is a consultant for Allergan, an implant manufacturer.


An Israeli study published in December that was based on a health insurers medical records, compared 24,651 women with silicone breast implants to 98,602 similar women without implants, and found that those with implants had a 22% increase in the risk of having any auto-immune or rheumatic disorder. It also found higher rates of Sjogrens, scleroderma and rheumatoid arthritis, as well as other illnesses.


Implants are not so innocent as presented, said Dr. Howard Amital, a rheumatologist who was the studys senior author. Though he acknowledged the study does not prove a causal relationship, he said that the association between implants and the disorders is highly indicative.


There is a reason for concern, he added. There is something we cannot ignore.


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Supplier Innovations Keep Lifting Industry

Automotive News

March 20, 2019

Automotive technologies are reaching new heights, and innovations are coming from new corners of the industry.


As the Automotive News PACE Awards celebrate their 25th year of recognizing supplier achievement in bringing solutions to market, a new era is taking shape in the industry.


The emergence of more advanced sensors, breakthroughs in materials and the application of artificial intelligence in vehicle functions are converging to yield auto components that deliver greater safety, heightened performance, better fuel efficiency and improved flexibility in design and manufacturing.


From these innovations will come more profitable vehicles, more electrification and still more autonomous controlbut best of all, ever more appealing autos.


This year, 33 finalists are being considered for 2019 PACE Awards, in fields ranging from premium audio packaging to the advanced computing capability of a multidomain controller.


Plastic fuel tanks stand up to high pressure: Plastic Omnium

  • What: INWIN plastic fuel tank.
  • Innovation: To control vapor emission from fuel tanks under higher pressure, hybrid vehicles use sealed canisters typically made of steel. Plastic Omnium has developed a lighter-weight, blow-molded plastic version that can stand up to the same pressures while providing the advantages of plastic, including corrosion resistance, packaging flexibility and cost effectiveness.
  • First customer: Hyundai Ioniq.
  • Website: plasticomnium.com.


Smaller cars, premium sounds: Bose Corp.

  • What: Personal sound system.
  • Innovation: Bose has developed an audio system that makes high-energy sound performance possible in subcompact vehicles where little room is available for traditional sound components. The design uses six speakers, including two 2.5-inch UltraNearfield speakers in the drivers seat headrest.
  • First customer: Nissan Micra.
  • Website: automotive.bose.com.


Lighter tailpipe architecture: Faurecia

  • What: Resonance free pipe.
  • Innovation: Faurecia introduced microperforated patches on tailpipes that render a resonator unnecessary. The result: The exhaust systems architecture is more flexible for packaging, and weight is cut by as much as half without any loss in noise and vibration performance.
  • First customer: General Motors for Chevrolet Silverado and GMC Sierra.
  • Website: faurecia.com.


Wheel sensors measure road conditions: Hella

  • What: SHAKE sensors for road condition analysis.
  • Innovation: Hellas road condition sensorscalled SHAKE, for Structural Health and Knock Emissionenable a real-time measurement of water on pavement to reduce hydroplaning. The sensors, placed inside a vehicles front wheelhouses, measure tire friction with the road and use a proprietary algorithm to make braking decisions.
  • First customer: Porsche 911.
  • Website: hella.com.


More flexible approach to battery fastening: Yazaki Corp.

  • What: Multidirectional battery terminal.
  • Innovation: Yazaki has designed an alternative to decades-old traditional vertical battery terminal fastening, which can result in concentrated stress on the clamped area. The multidirectional innovation provides a low-cost, high-efficiency way to fasten from a horizontal direction, creating a more flexible battery installation during vehicle assembly.
  • First customer: Toyota Camry.
  • Website: yazaki.com.


Sensor improves rear and side views: Continental

  • What: Gen 3 radar sensor.
  • Innovation: Continentals 24-gigahertz short-range radar sensor enables a vehicle to detect objects to the rear and side, providing extended blind-spot detection and warning, rear cross-traffic alert with auto braking ability, parking spot detection and closing object detection warning. It also provides automatic recognition when a trailer is attached, measuring the trailers length and determining if there is enough space to change lanes.
  • First customer: Ford F-150.
  • Website: continental-corporation.com.


Automotive News.

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New Developments in Conducting Business in Mexico and the Impacts on Automotive Manufacturers

Mondaq Business Briefing

March 19, 2019

The global automotive industry is experiencing one of the most significant trade shifts in over two decades, specifically the new developments in conducting business in Mexico, including international trade and product safety.


In fall 2018, the United States, Canada, and Mexico reached an agreement to revise the 25-year-old North American Free Trade Agreement (NAFTA). The new agreement, now named the United States-Mexico-Canada Agreement (USMCA), is not expected to take effect until 2020 (at the earliest) as it needs to make its way through the legislative process in each country.


As it stands now, USMCA is expected to have a profound impact on the automotive industry, particularly due to a much stricter Rule of Originwhich says that 75% of a car or trucks components must be manufactured in North America, an appreciable uptick from the current 62.5% under NAFTA.


Rule of Origin: As per the former Mexican Minister of Economy, Ildefonso Guajardo Villarreal, 70% of current production in Mexico already complies with the USMCA. It is expected that due to the USMCA requirements, Mexico will receive greater investments as a result of production transferring from China, Korea, Japan, and other countries. Regardless of their placement in the North American automotive industry food chain, in the short term, all players need to evaluate how the USMCA will impact their current activities, possibly as early as 2020, and take concrete actions based on same; in the medium term, companies operating in the NAFTA/USMCA region need to be on the lookout for USMCAs intended renegotiation by the now Democrat-controlled U.S. Congress; and, in the long term, manufacturers should expect that Mexicos export orientation and openness will remain unmodified.


Ultimately, the USMCA will require the supplier-to-OEM relationship to be much stronger and closer than in the original NAFTA. Companies that understand and prepare for the new requirements in advance will find that they have a strategic advantage over companies that are not proactive in preparing for the new marketplace rules.


Market Intelligence


Cost Impact of USMCA: In a survey of 100 U.S.-based auto executives conducted by Propeller Insights on behalf of LevaData in December 2018, 63% of automotive executives believed that production costs would increase due to USMCA. Although survey respondents seemed to believe there would be cost issues in the short term, 78% of automotive executives felt that the changes required by USMCA would have a positive impact on their company in the long term. Fifty-three percent of those surveyed felt USMCA would ultimately increase North American vehicle manufacturing and provide a net improvement for workers and consumers.


The survey also found that auto executives are very aware they will need to find ways to save money in the supply chain to decrease costs: 36% plan to renegotiate part supply deals to pass costs on to suppliers and 35% will look for cost savings in the production process. This comes because the proposed USMCA document requires automakers to manufacture 40% of their motor vehicles in facilities where assembly workers earn at least $16 an hour. Though this is largely not a problem for U.S. and Canadian production facilities, where workers already make more than that on average, it is problematic for Mexico, where workers often make less, though up to 15% can be credited through expenditures in technology and assembly of specific parts (engine, transmission and advanced batteries). Making matters trickier, many U.S. automakers recently moved some of their production to Mexico for that very reasonthe work was cheaper than in the United States or Canada.


New Leadership in Mexico: NAFTA and USMCA updates are not the only developments those in the auto industry should be thinking about when it comes to trade with Mexico. Former Mexico City Mayor Andrs Manuel Lpez Obrador began his six-year term as president of Mexico in December 2018. U.S. and other foreign companies operating in the country should be aware of changes his presidency might bring. If the United States withdraws from NAFTA, we think that Mexico will strengthen its internal export promotion programs so that the near-shore advantage, and manufacturing experience in complex (i.e., aerospace and motor vehicles) chains of production, is not lost. In particular, we expect continued strong support for low tariffs on the Mexican side and continued support for their export-oriented programs (commonly referred to as maquiladora), which give advantages to U.S. companies that operate near the U.S.-Mexico border and bring in goods from the United States for further processing in their facilities.


Recent legal developments


Revisions to Product Safety Regulations in Mexico: Mexico has revamped its product safety regulatory framework to bring aspects into conformance with the United States. Compliance with product safety requirements in Mexico used to be relatively relaxed, but is now more stringent. For example, it is now necessary to notify the Mexican regulatory agency when a company identifies a risk.


Along with recent changes to product safety and corruption risks, a few years ago class actions were permitted in Mexico and are becoming more relevant in this new environment. Companies should also be aware of the mandatory recall requirements enforced by the Mexican consumer protection agency (PROFECO) and should get their compliance programs up to speed. In what was once a voluntary process, PROFECO can remove or require repair for defective products, open investigations regarding product safety concerns, and impose relevant sanctions on manufacturing companies in Mexico that are not complying with product safety standards or that could otherwise harm the life, safety, or health of consumers.


Navigating the road ahead


Foleys 2019 Automotive Industry Conference featured a panel of automotive executives and professionals from Mexico City who shared how they are Navigating the Road Ahead regarding the new developments in conducting business in Mexico, specifically international trade and product safety concerns. Bernardo Altamirano-Rodrguez, CEO of Mexicos Better Business Bureau, noted that there are three basic restraints to conducting business in Mexico:

  • Non-U.S. competitors that are conducting business in Mexico do not need to comply with the Foreign Corrupt Practices Act, which may put U.S. competitors at a disadvantage in Mexico. While most countries have anti-corruption laws, U.S. enforcement of its laws is by far the most stringent.
  • The USMCAs new framework for government procurement.
  • Political restrictions resulting from an ethical transformation away from corruption, which require a company to now construct a public relations narrative with clear goals, objectives, and societal benefits.


The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.


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Detroit Is Electric Motor City in a Frenzied Battle for Auto Engineering Talent

The Free Lance-Star

March 19, 2019

By Mark Phelan


After years when Detroit was Ground Zero for skepticism about electric vehicles, the traditional auto industrys hometown has become a hub of EV action.


The trend is attracting companies, cash and jobspotentially including jobs for engineers and executives displaced by restructuring at General Motors and Ford.


At the same time, established automakers and suppliers are boosting their work on EVs at their local engineering centers, making southeast Michigan one of the worlds centers of EV development.


Companies come for the regions talent, a bounty of engineers and executives who know how to turn ideas into vehicles that start every day, survive crashes and can be built by the million.


For more than a century, companies in and around Detroit have refined complex electromechanical devices to make them smaller, cheaper and more reliable for mass-market use in cars, said John Voelcker, former editor of Green Car Reports.


Thats what auto engineers do. And more of them do it around Detroit than anywhere else in North America.


Rivian Automotive, which got a major endorsement when Amazon recently invested $700 million, is a prime example. The developer of electric pickups and SUVs drew huge crowds when it showed its first two models at the Los Angeles auto show late last year. Rivian moved its headquarters to Plymouth, Mich., just west of Detroit, in 2015. More than 350 people work there in design and engineering. Rivian plans to build vehicles at a former Chrysler and Mitsubishi plant that it owns in Illinois.


Money talks


When somebody puts in $700 million, it gets your attention, said Glenn Stevens of MichAuto and the Detroit Regional Chamber, both of which work with companies that may invest and expand in the region.


Bollinger Motors last year relocated its headquarters, engineering and design from New York state to Ferndale, Mich., just north of Detroit. Employment is just a handful now as Bollinger completes prototypes for electric pickups and SUVs scheduled for production in small numbers starting in 2020. The company hopes to build the B1 SUV and B2 pickup in Southeast Michigan.


Everything we can, were going to do in Detroit, Bollinger brand director Mark Foster said. Like most people, executives considering investment and hiring in the region frequently use Detroit as a shorthand that encompasses much of southeast Michigan.


Detroit Custom Chassis plant on Detroits east side just began installing powertrains and controls from Motiv Power Systems in Ford F-59 truck frames for electric medium-duty vehicles such as delivery vans.


Companies come here for the talent, experience and because we have test facilities and a physical environment with extremes of hot and cold, snow and rain for testing, said Lou Donato of the Society of Automotive Engineers.


Town is swimming in talent


The giants are on board alongside the newcomers.


Fords high-profile plan to turn Detroits Corktown neighborhood into a center of electric and autonomous vehicle development added momentum.


More quietly, GM has reorganized its whole engineering structure to speed up development of a host of electric and autonomous vehicles.


Every automaker is terrified of being left behind, said Drew Winter, Wards Automotive content director. Even though they wont sell millions of EV in the immediate future, they have to gear up now.


Were seeing the beginnings of an industry thats changing.


Welcome to the Electric Motor City.


This town is swimming in talent, said Jim Taylor, a veteran auto executive and engineer who led several brands at GM and has worked with startup EV makers. The battle to develop these vehicles is a people war. To be a credible manufacturer, you need to fill 600-700 seats with the skills needed to take a vehicle from design to the dealership.


Draw a 30-mile circle around Detroit and you find more people with that skill set than anywhere else. Its the technology hub. Thats what draws these companies.


You win the battle resume by resume.


Help wanted


GMs recent white-collar layoffs could be a bonanza for EV companies, Taylor said. That many people with that kind of experience dont come on the market often. They may be available just when new EV companies need them.


And not just vehicle makers. Suppliers developing everything from electric fast-charge systems to roads that communicate with vehicles have also been drawn by southeast Michigans concentration of engineering talent, research facilities and places to test new technologies.


Karma Automotive, an electric luxury carmaker based in California and owned by Chinese auto supplier Wanxiang Group, realized it needed a Detroit engineering center to work with suppliers. It has about 50 engineers work at in Troy.


We have so many suppliers and key partners in southeast Michigan that its critical to have an office there, Karma spokesman Dave Barthmuss said. Were a California company, through and through, but you cant ignore the expertise available in Detroit.


At the same time, GM and Ford are ramping up EV development with the aim of launching high-profile new vehicles in the next two to three years. Fiat Chrysler recently joined the party, announcing its $4.5 billion investment in new local assembly plants and vehicles includes its first major move into EVs. At least 18 automakers have engineering center in the Detroit area. All of them are believed to be doing EV work, as are the many supplier tech centers around town.


The Detroit area has become a center of expertise for companies developing electric vehicles and infrastructure, said Jim Saber, president and CEO of NextEenrgy, a Detroit-based tech incubator. Start-ups and many established companies from outside the region are drawn to the area to and access the talent and partnerships to develop produce the vehicles and systems at scale.


Want a factory? Itll cost you.


Most tech centers employ dozens to hundreds of people. Detroits deep talent pool has proven irresistible for many companies looking for talent. Luring new manufacturing is different.


Vince Carioti, director of German supplier Phoenix Contact E-mobility North American operations was originally told to locate in Silicon Valley when the company needed a tech center to support its move into developing EV charging systems.


I felt that with our ties to the U.S.-based automotive in Detroit and all the focus on electrification and autonomy, we should be located here Carioti said.


This was a challenge. There is so much press and media promoting the Valley and the companies located there.


He persuaded Phoenixs CEO to come and see Detroit. In the end I was successful in convincing him to locate in Ann Arbor. We have one facility [there] and a presence at the Landing zone in downtown Detroit.


My goal is to eventually have some type of assembly of inlets and charging cables here in the U.S. maybe even Michigan.


Love em or hate em, government subsidies play a big role in where companies build vehicle assembly sites, which can employ thousands.


Celebrated auto designer Henrik Fiskers eponymous company recently hired veteran politician Richard Gephardt to select a site for a proposed plant to build around 100,000 electric SUVs a year. Fisker is open about the fact that incentives play a large role in the process. Hes narrowed choices to four states. Michigan isnt one of them.


Detroit Free Press.

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