November 23, 2024

You are here: Home / Archives for health authorities

Health Fears Over Suspect French Breast Implants Spread Abroad

December 22, 2011 by Leave a Comment

It is unclear whether there are health risks posed by the substandard silicone used in the implants, and the French government is expected to decide soon whether to require as many as 30,000 women in France to have their implants removed.

If the government mandates the removals, it will also pay for the procedures, though not for replacements. Regulators will have to weigh whether the known risks associated with removing the implants outweigh the uncertain risks and anxieties associated with leaving them intact.

The British health authorities on Wednesday sought to calm women’s fears, saying that there was no evidence that the suspect implants, which were manufactured by Poly Implant Prothèse, a company known as PIP, had caused cancer. They urged women who had received them to take any concerns to their surgeons, but they also said, “There is currently no evidence to support routine removal” of the implants.

Britain’s surgical associations also tried Wednesday to soothe anxiety. “The message here is not to panic,” said a consultant plastic surgeon, Douglas McGeorge, who spoke for the British Association of Aesthetic Plastic Surgeons.

Silicone implants have had a contentious history, with the United States imposing a 14-year moratorium on their use that ended in 2006, after years of lawsuits contending that they had caused cancer. None of PIP’s implants appear to have been sold in the United States.

The Institute of Medicine and the Food and Drug Administration eventually determined that there was no evidence that silicone implants were harmful.

Concerns over the silicone in the suspect implants began to build last year, when PIP was shut down and prosecutors began investigating the company for possible fraud. The French authorities said the implants had been rupturing at a rate double the industry average, the French media reported.

But the concerns over the company’s implants caught the attention of European health officials after a woman whose implant had ruptured died last month from a rare cancer called anaplastic large-cell lymphoma.

The French media reported that she was the eighth woman with an implant manufactured by the company to have died of cancer, although the statistical significance of that is unclear.

French prosecutors have said that Poly Implant Prothèse substituted a cheap, industrial-grade silicone for medical-grade silicone that is the industry standard. The French authorities have said the substandard product causes inflammation to body tissues when implants are compromised. But so far, they have emphasized, there is no evidence linking it to cancer.

“In case of rupture, you’d have a dangerous quantity of silicone in your body,” said Laurent Lantieri, a plastic surgeon at a hospital near Paris.

Hélène Guillois, 29, a nutrition student who lives in northern France, said she had the company’s devices implanted seven years ago.

“I’m worried, because of the possible damage this could cause,” Ms. Guillois said. “No one is really capable of saying what will be the effects. Maybe we’ll see in 10 years or so. Like all the big French medical scandals.”

Breast implants, which are essentially small silicone rubber bags filled with a material, typically silicone or a saline solution, are used after breast cancer surgery or simply for cosmetic purposes.

More than 1,000 of the estimated 30,000 French women fitted with the devices have experienced ruptures or leakage. Tens of thousands more in other countries have had the company’s devices implanted, because PIP exported 80 percent of its products, many of them to Britain, Spain and Latin America.

More than 40,000 British women are estimated to have received the company’s implants.

The implants were also used in Brazil, Argentina, Chile, Colombia and Venezuela. In Brazil, the National Agency of Sanitary Vigilance prohibited the importation and use of the implants in April 2010, after concerns about their safety emerged in France.

Chile’s Public Health Institute asked the estimated 1,000 or so women thought to have implants from the French company to contact their doctors so the implants could be removed if ruptures occurred. Otherwise, Chilean officials asked women with the implants to undergo annual exams.

Sebastião Guerra, the director of the Brazilian Society of Plastic Surgery, said, “We do not have significant reports of either ruptures or rejections or even cancer associated with those PIP implants, and we don’t know why there is this difference with respect to the French news.”

Prosecutors in Marseille have been investigating the company for possible fraud and reckless endangerment. They say it cut costs over the last decade by using an industrial silicone gel that was not approved for medical use and that cost a fraction of the medical-grade material.

Several hundred thousand of the implants had been manufactured by the time issues were raised early last year about their quality.

Yves Haddad, a lawyer for the company’s founder and chairman, Jean-Claude Mas, said there was no evidence that the product, “even if it was unapproved, is dangerous for health.”

The Marseille prosecutor’s office declined to comment.

Reporting was contributed by Ravi Somaiya from London; Simon Romero from São Paulo, Brazil; Gardiner Harris from Washington; and Lis Moriconi from Rio de Janeiro.

Article source: http://www.nytimes.com/2011/12/22/health/health-fears-over-suspect-french-breast-implants-spread-abroad.html?partner=rss&emc=rss

Filed Under: Global Business Tagged With: , ,

Fair Game: A Fed Banker Wants to Break Up Some Banks

December 11, 2011 by Leave a Comment

Happily, though, reducing the perils of gargantuan institutions — and the threat to taxpayers — is an idea that seems to be taking hold in Washington. To be sure, the army arguing for change is far outgunned by the battalions of bankers and lobbyists working to maintain the status quo. But some combatants seeking reform believe they are making headway.

Richard W. Fisher, the president of the Federal Reserve Bank of Dallas, is one. In a speech last month he described, quite colorfully, the problems of these unwieldy institutions and the regulatory ethic “that coddles survival of the fattest rather than promoting survival of the fittest.” Bank regulators should follow the lead of the health authorities battling obesity rates among our population, he said, adding that he favored “an international accord that would break up these institutions into more manageable size.”

This is a banker talking, not a member of the Occupy Wall Street drum circle.

And yet, some have criticized Mr. Fisher for voicing these sensible views — a sign to him that the issue is gaining traction. In an interview last week, he said: “Judging from the anguished calls I received from lobbyists for the megabanks, the ‘attaboy’ calls I am getting from regional and community bankers and the requests for copies of the speech from senators on both sides of the aisle, it appears this is a hot topic.”

That Mr. Fisher has received encouragement from both conservatives and liberals on his views leads him to conclude that “this is an issue that can transcend bipartisan politics.”

Last week, Senator Sherrod Brown, the Ohio Democrat who leads the Senate Banking subcommittee on financial institutions and consumer protection, held a hearing on how to shield Main Street from what he calls megabank risk. In April 2010, he was a co-sponsor of the Safe Banking Act of 2010 with Ted Kaufman, the former Democratic senator from Delaware. The bill, which would break up some of the largest banks by requiring caps on institution size and leverage, ran into a buzz saw of opposition from the usual suspects.

But Mr. Brown soldiers on; he said in an interview on Thursday that he, too, believes the debate is changing. “We’re seeing sentiment grow on the Brown-Kaufman idea,” he said. “We are seeing some people who are pretty conservative here understanding the implicit subsidies these megabanks receive. Our goal is that senators understand this to the point of wanting to take action.”

He said he hoped his hearing would educate colleagues on the significant financial bounties received by big banks that are not allowed to fail, especially their lower borrowing costs — a result of investor belief that taxpayers will rescue them. This places these banks at an unfair advantage over their smaller competitors.

“Why should the Bank of America enjoy an advantage the Peoples Bank in Coldwater, Ohio, doesn’t get?” Mr. Brown asked. “The government’s got to pull away from this and level the playing field.”

Providing testimony at Mr. Brown’s hearing were Sheila Bair, former chairwoman of the Federal Deposit Insurance Corporation; Simon Johnson, a professor at the Sloan School of Management at M.I.T.; Philip L. Swagel, a professor of international economic policy at the University of Maryland School of Public Policy; and Arthur E. Wilmarth Jr., a law professor at George Washington University Law School.

Ms. Bair, one of the few regulators to have fought the anything-goes bailouts during the crisis, espoused her usual no-nonsense perspective on a variety of important topics. “I know that many members of this subcommittee heard the same arguments that I heard during the crisis — that bailouts were necessary or the ‘entire system’ would come down,” she said. “But we never really had good, detailed information about the derivatives counterparties, bond holders and others who we were ultimately benefiting from the bailouts and why they needed protecting.”

Such details are still kept under wraps. Ms. Bair urged the Fed and the F.D.I.C. to write rules requiring banks to report on their interrelationships. That way, distress at one institution can be recognized before it causes crippling losses at another.

In her testimony, Ms. Bair also urged regulators to write rules requiring executives and boards to be “personally accountable for monitoring and compliance” of the institutions they oversee.

When I asked her how this could be done, she said: “There should be personal certifications and, at a minimum, civil penalties assessed by the banking regulators against the boards and management, as well as compensation clawbacks if there are losses to the organization because of proprietary trading. Regulators can’t run these financial institutions for the management.

“What in the world are they being paid for?”

At the moment, they are being paid for taking risks that generate lush bonuses when things go well but that require taxpayer bailouts when the tide turns. Main Street understands that this is wrong and that allowing it to continue is dangerous. It’s past time that Washington did something about it.

Article source: http://feeds.nytimes.com/click.phdo?i=7e3b9f48d38830029ac1644657dd736b

Filed Under: Business News Tagged With: , ,

E. Coli Not Found in Initial Testing of Sprouts

June 6, 2011 by Leave a Comment

The announcement, made at a news conference Monday afternoon, came a day after officials had identified tainted sprouts from a farm in the Uelzen area in the north as the “most convincing” cause, and shut it down while it tested 18 sprout mixtures, including beans, broccoli, peas, chickpeas, garlic, lentils, mung beans and radishes. The sprouts are often used in mixed salads.

The results from the remaining 17 tests were expected within 24 hours.

The German authorities had acted prematurely once before in their investigation, blaming cucumbers grown in Spain for the outbreak after preliminary tests showed that they might have contained toxic E. coli bacteria. Further tests showed that the Spanish cucumbers did not contain the strain making people sick, and investigators then backtracked.

That episode infuriated Spanish farmers who lost tens of millions of dollars in sales and were forced to abandon ripe vegetables to rot in the fields, as demand collapsed.

The outbreak, which German health authorities first reported in late May, is caused by a rare strain of toxic E. coli that can cause bloody diarrhea. In extreme cases it can cause acute kidney failure and death. In previous outbreaks involving other strains of E. coli, kidney failure appeared most often among children. In this outbreak, most victims with kidney failure have been adults and more than two-thirds have been women. Cases have cropped up in at least 10 countries in Europe, but virtually all have been traced to northern Germany.

Sprouts had seemed like a likely source, and some experts were surprised that Germany had not focused on them earlier. Since 1996, sprouts have been linked to at least 30 illness outbreaks, according to a United States federal food safety Web site that warns that children, the elderly, pregnant women and people with weak immune systems should not eat uncooked sprouts.

Sprouts were found to be the cause of one of the most severe series of outbreaks of E. coli ever identified, in Japan in 1996. In those outbreaks about 10,000 people, many of them children, fell ill after eating food containing uncooked radish sprouts. That involved the common O157:H7 strain of E. coli. The current outbreak in Germany involves a rare strain known as O104:H4.

Bacteria can flourish in the warm, humid conditions in which sprouts are grown, according to a report by the Centers for Disease Control. Investigators have sometimes found that the seeds used to grow sprouts are contaminated with bad bacteria, like E. coli or salmonella. Once those seeds start growing, the bacteria can easily spread.

The Spanish government did not comment Sunday on the latest news in the German investigation. But mounting evidence that the problem should never have been linked to produce from Spanish farms is likely to raise pressure on Germany and the European Union to compensate Spanish farmers for estimated weekly losses of $286 million in revenue because of canceled shipments, as well as massive job cuts among seasonal growers in Andalusia.

That area, the Spanish agricultural heartland, was already suffering the worst unemployment problem in the country.

Article source: http://feeds.nytimes.com/click.phdo?i=4d9c39b84edb345551539c42e2377508

Filed Under: Business News Tagged With: , ,