Tag Archives: medical devices

Metal hip patients ‘need annual checks’

Patients with a common type of metal hip implant should have annual health checks for as long as they have the implant, according to the UK body for regulating medical devices. the all-metal devices have been found to wear down at an accelerated rate in some patients, potentially causing damage and deterioration in the bone and tissue around the hip. there are also concerns that they could leak traces of metal into the bloodstream, which the annual medical checks will monitor.

Hours before critical coverage from the British Medical Journal and the BBC, the Medicines and Healthcare products Regulatory Agency (MHRA) issued new guidelines on larger forms of ‘metal-on-metal’ (MoM) hip implants. Advice on smaller metal devices or those featuring a ceramic head has not changed. Previously, guidelines suggested larger MoM implants should only be checked annually for five years after surgery. the agency now says the annual check-ups should be continued for the life of the implant. Check-ups, they say, are a precautionary measure to reduce the “small risk” of complications and the need for further surgery.

Together with the recent controversy over PIP breast implants, the news has caused the media and patient groups to call for tighter regulation of medical devices, perhaps bringing the approval process into line with that of medicines. Before they can be approved for wider use drugs must undergo several years of laboratory, animal and human testing .

There are numerous designs and materials used to make hip implants. in recent days the MHRA has issued major updates to its advice on a type of metal-on-metal (MoM) hip replacement. as the name implies, MoM implants feature a joint made of two metal surfaces – a metal ‘ball’ that replaces the ball found at the top of the thigh bone (femur) and a metal ‘cup’ that acts like the socket found in the pelvis.

What should I do if I have a hip implant?

Consult your doctor if you do not know which type of implant you have or if you have any concerns about your hip replacement. the new guidance only applies to large head metal-on-metal implants, which have been used in only a minority of hip replacements. Patients who have MoM implants should ensure they attend any follow-up appointments as usual, and can consult the hip implant pages on NHS Choices for any further updates.

Consult your doctor if you have any of the following symptoms:

  • pain in the groin, hip or leg
  • swelling at or near the hip joint
  • a limp or problems walking

These symptoms do not necessarily mean that your device is failing, but they do need investigating.

Any changes in general health should also be reported, including:

  • chest pain or shortness of breath
  • numbness or weakness
  • changes in vision or hearing
  • fatigue
  • feeling cold
  • weight gain
  • change in urination habits

The MHRA’s updated advice concerns the type of MoM implant in which the head of the femur is 36mm or greater. This is often referred to as a ‘large head’ implant. the agency now says that patients fitted with this type of implant should be monitored annually for the life of the implant, and that they should also have tests to measure levels of metal particles (ions) in their blood. Patients with these implants who have symptoms should also have MRI or ultrasound scans, and patients without symptoms should have a scan if their blood levels of metal ions are rising. the previous guidance on this type of hip implant, issued in April 2010, advised that patients should be monitored annually for no fewer than five years.

Advice on monitoring patients with other types of hip implants remains the same, and guidance has not changed on:

  • MoM hip resurfacing implants – where the socket and ball of the hip bone has a metal surface applied to it rather than being totally replaced.
  • Total MoM implants where the replacement ball is less than 36mm wide.
  • A particular range of hip replacements called DePuy ASR – these hip replacements were recalled by their manufacturer, DePuy, in 2010 because of high failure rates. the company made three types of ASR implant.
  • Implants featuring ceramic heads.

It is estimated that, in total, 49,000 people in the UK have been given metal-on-metal implants with a width of 36mm or above. This represents a minority of the patients given hip replacements, who mostly have devices featuring plastic, ceramics or smaller metal heads.

In 2010 there were 68,907 new hip replacements fitted, and approximately 1,300 of these surgeries used an MoM implant sized 36mm or above – a rate of around 2%.

All hip implants will wear down over time as the ball and cup slide against each other during walking and running. although many people live the rest of their lives without needing their implant to be replaced, any implant may eventually need surgery to remove or replace its components. Surgery to remove or replace part of the implant is known as ‘revision’ and, of the 76,759 procedures performed in 2010, some 7,852 were revision surgeries.

However, data now suggest that large head MoM hip implants (those with a width of 36mm or greater) wear down at a faster rate than other types of implants. as friction acts upon their surfaces it can cause tiny metal particles (medically referred to as ‘debris’) to break off and enter the space around the implant. Individuals are thought to react differently to the presence of these metal particles, but, in some people, they can trigger inflammation and discomfort in the area around the implant. Over time this can cause damage and deterioration in the bone and tissue surrounding the implant and joint. This, in turn, may cause the implant to become loose and cause painful symptoms, meaning that further surgery is required.

News coverage has also focused on the MHRA’s recommendation to check for the presence of metal ions in the bloodstream, potentially released either from debris or the implant itself. Ions are electrically charged molecules. Levels of ions in the bloodstream, particularly of the cobalt and chromium used in the surface of the implants, may, therefore, indicate how much wear there is to the artificial hip.

There has been no definitive link between ions from MoM implants and illness, although there has been a small number of cases in which high levels of metal ions in the bloodstream have been associated with symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system and thyroid gland.

The MHRA points out that most patients with MoM implants have well functioning hips and are thought to be at low risk of developing serious problems. However, a small number of patients with these hip implants develop soft tissue reactions to the debris associated with some MoM implants.

In the UK, the MHRA is the government agency responsible for ensuring that medical devices work and are safe. the MHRA audits the performance of private sector organisations (called notified bodies) that assess and approve medical devices. once a product is on the market and in use, the MHRA has a system for receiving reports of problems with these products, and will issue warnings if these problems are confirmed through their investigations. It also inspects companies that manufacture products to ensure they comply with regulations.

This system differs greatly from that for testing and approving drugs. Drugs require several years of research testing and trials before they can be approved for clinical use.

The MHRA has convened an expert advisory group to look at the problems associated with MoM implants. This meets regularly to assess new scientific evidence and reports from doctors and medical staff treating patients. the agency says it is continuing to monitor closely all the latest evidence about these devices and may issue further advice in the future.

In the US, the Food and Drug Administration (FDA) says it is gathering additional information about adverse events in patients with MoM implants. in the meantime, it advises patients with MoM hip implants who have no symptoms to attend follow-up appointments as normal with their surgeon. Patients who develop symptoms should see their surgeon promptly for further evaluation.

In light of the PIP breast implant controversy and this new information on hip implants, there is currently intense scrutiny on the way medical devices are regulated in the UK and Europe, with patient groups and the media arguing that medical devices should be regulated in a similar way to medicines.

Clearing a medicine for use in the UK is a lengthy process involving several stages of laboratory and animal testing, and then carefully controlled and monitored tests in humans. only once there is enough evidence to suggest that a medicine is reasonably safe can it enter clinical use, and even then patients will be monitored to look at the longer-term effects of the drug.

However, medical devices are not required to go through human trials before entering use, and can currently be approved on the basis of mechanical tests and animal research. While certain devices, such as hip implants, have been monitored through systems such as the National Joint Registry, in light of the recent health concerns over PIP breast implants, patient groups are calling for more testing before devices are allowed into clinical use, and closer mandatory monitoring schemes to ensure their safety once they enter the market.

Metal hip patients ‘need annual checks’

UK Study Prompts Call for Wider Ban on Metal Hips

New research confirmed that all-metal artificial hips fail more often than other types, fueling concerns about the devices and prompting a call from researchers this week for a ban.

The analysis in The Lancet medical journal came two weeks after Britain’s medical regulator said nearly 50,000 Britons with metal-on-metal hips needed annual check-ups to monitor for problems, including exposure to toxic metals.

The finding will likely fuel criticism about the regulation of medical devices in the wake of a scandal over French-made breast implants and past problems with other implantable devices, including faulty leads on some heart defibrillators.

Metal-on-metal hips were developed to be more durable than traditional implants, which combine a ceramic or metal ball with a plastic socket.

But recent experience suggests they may actually do worse, prompting the recall of one device made by Johnson & Johnson that critics argue should never have been allowed on the market.

Results from the most comprehensive study to date now show that there is a 6.2 percent chance patients with all-metal hips will need a replacement within five years – some three times greater than the revision rate seen with older implants.

The rate was particularly high with larger-head implants and those used in women, in whom failure rates were up to four times higher, the researchers said.

The team from the University of Bristol analysed data from the National Joint Registry of England and Wales covering more than 400,000 hips replacements, including 31,171 all-metal ones, that were undertaken between 2003 and 2011.

The results, they said, were unequivocal: “Metal-on-metal stemmed articulations give poor implant survival compared with other options and should not be implanted.”

Their analysis did not cover resurfacing systems, which avoid the use of a stem sticking into the bone, such as Smith & Nephew’s Birmingham Hip Resurfacing joints.

TIGHTER REGULATION

In recent years, the use of metal-on-metal implants has declined in Britain, but they are still used extensively around the world, including in the United States.

Art Sedrakyan of Cornell University said the problem highlighted weaknesses in the regulatory systems on both sides of the Atlantic due to “outdated and low-threshold regulatory pathways.”

In a strongly worded Lancet commentary accompanying the latest research, he called for better studies before implants reach the market.

“we are left with more than 500,000 patients with metal-on-metal prostheses in the USA and more than 40,000 in the UK who are at elevated risk of device failure, which will inevitably result in the burden of further surgical treatment as well as billions of dollars in costs to taxpayers,” he said.

Ashley Blom of the University of Bristol said that total hip replacement surgery remained a very successful operation for the vast majority of people but regulators should learn lessons as they seek to balance safety against innovation.

“in this case, with the benefit of hindsight, I think that tighter regulation may have prevented this,” he told Reuters.

Under the new guidelines from Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA), doctors are being advised to consider removing and replacing implants if patients have abnormal MRI scans or if metal ion levels in the blood reach worrying levels.

With the exception of J&J’s DePuy ASR system, which was pulled from the market in 2010, the MHRA decided in its recent ruling against a ban on use, arguing that stemmed metal-on-metal implants could still be good news for some patients.

Other companies that make metal-on-metal hip implants include Zimmer, Stryker, Corin and Biomet.

UK Study Prompts Call for Wider Ban on Metal Hips

New silicone gel-filled breast implant comes to U.S. market

Silicone gel-filled breast implants. Image: FDA

Dr. Larry Nichter of the Pacific Center for Plastic Surgery would like to make prospective breast augmentation patients aware that the FDA has approved a new silicone gel-filled breast implant made by Sientra, inc. for use in the United States.

The implants will be available for women at least 22 years old seeking augmentation surgery, and women of any age seeking breast reconstruction surgery.

Silicone gel-filled breast implants are medical devices implanted under the breast tissue or under the chest muscle for breast augmentation or reconstruction. these implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells.

This approval introduces a third company into the U.S. breast implant market, which previously consisted only of Allergan and Mentor.

The deputy director for for science at the FDA’s Center for Devices and Radiological Health, Dr. William Maisel, commented that although silicone gel-filled breast implants have demonstrated consistent safety, “It’s important to remember that breast implants are not lifetime devices. Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential.”

The approval of these new implants follows a 3-year study involving clinical trials of the implants on 1,788 women.

As a condition of the approval, Sientra will carry out five- and ten-year studies into the long-term health effects of their implants.

Source: FDA – FDA approves new silicone gel-filled breast implant

New silicone gel-filled breast implant comes to U.S. market

FDA OKs 3rd Silicone-Gel Breast Implant

FRIDAY, March 9 (HealthDay News) — a new silicone-gel breast implant received conditional approval Friday from the U.S. Food and Drug Administration. The implant can be used for breast augmentation in women 22 and older and for breast tissue reconstruction at any age.

The newest implant, manufactured by Sientra of Santa Barbara, Calif., becomes the third approved for use in the United States, joining devices made by Allergan and Mentor. As a condition for approval, Sientra will continue studies on the implant’s long-term safety, effectiveness and risks of rare diseases, the FDA noted.

“Data on these and other approved silicone-gel filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness,” Dr. William Maisel, deputy director for science in the FDA’s Center for Devices and Radiological Health, said in an agency news release.

Silicone breast implants have been controversial for years, with critics contending that the devices can rupture and leak silicone, potentially causing a variety of health problems, including cancer and lupus.

Classified as medical devices, silicone implants are surgically placed under breast tissue or chest muscle to reconstruct or augment the breast.

In reconstruction, the implant usually replaces breast tissue removed because of cancer or trauma or breast tissue affected by a severe breast abnormality. another reason is to revise or improve results from a previous reconstruction surgery, according to the FDA.

Similarly, breast augmentation is used to increase breast size or to improve on previous augmentation surgery.

The FDA approval of Sientra’s implant is based on three years of data from clinical studies on nearly 1,800 patients. Complications included tightening of the area around the implant, re-operation, implant removal, uneven appearance and infection, according to the agency’s release.

The company’s additional long-term studies will include a seven-year follow-up of the current participants; a 10-year study of nearly 5,000 women to monitor long-term complications, including rheumatoid arthritis, breast and lung cancer; and five studies focusing on possible links between the new implant and connective tissue and neurological diseases, brain cancer, cervical/valvular cancer and lymphoma, the FDA said.

Reaction to the latest approval came swiftly.

Dr. John Oeltjen, an assistant professor of plastic surgery at the University of Miami School of Medicine, thinks the FDA decision is a good one.

“The implant from Sientra is like the implants from other companies already marketing implants,” he said. “So that’s not out of line.”

“In general, there are no problems with silicon gel implants,” he said. The advantage of silicon gel over saline implants is that the silicon has a more natural look and feel, he added, while saline implants can wrinkle, which can show through the skin.

However, Oeltjen said he would like to see the FDA also allow marketing of contoured implants, which are not round, but shaped more like a natural breast.

Dr. Jeffrey C. Salomon, a clinical professor of plastic surgery at Yale University School of Medicine, noted, “Sientra is a brand that has been used in Brazil for an extended length of time, and I doubt that there were concerns about cancer, otherwise the FDA would have not approved them.”

He added, “While the next generation of breast implants is the so-called form stable variety, those implants have not been released in the U.S. despite being used throughout the world for a few years.”

“The form stable implant does not develop capsular contracture, which is a response by the body to a foreign object and can result in pain and discomfort as the implant is squeezed by fibers created by the immune system,” he added. “And that is really the category of breast implant surgeons are anticipating the release of.”

Dr. Alan Matarasso, a plastic surgeon at Lenox Hill Hospital and Manhattan Eye, Ear and Throat Institute in New York City, said: “This [the FDA decision] is exciting information for patients because it offers another choice for women undergoing breast cancer reconstruction or cosmetic breast augmentation.”

Silicone gel implants had been banned in the United States for 14 years, until 2006 when the FDA approved the ones made by Allergan and Mentor for breast reconstructive surgery and for breast enlargement in women 22 and older.

But, when the ban was lifted, the FDA noted that there wasn’t a lot of data on adverse effects, including what the agency called “rare events” and “long-term performance.” in light of this, the agency required the manufacturers to do studies on the implants’ safety and performance after their approval.

Then last September, after a contentious two-day hearing, the FDA ruled that silicone implants were safe and could remain on the market. However, the agency said at the time that it would work with manufacturers of the devices approved for use in the United States to improve studies gauging the health of women who received the implants.

The FDA emphasized last year that silicone implants don’t last forever, with as many as half of women with such implants requiring removal within 10 years of the initial surgery. according to the agency, one in five women who receives silicone implants to increase the size of her breasts will need to have the devices removed within 10 years due to complications. And as many as half of women who receive implants for reconstruction after breast surgery will need them removed within the same time frame.

Common complications include: hardening of the area around the implant; the need for additional surgeries; and implant removal. other frequent problems include implant rupture, wrinkling, breast asymmetry, scarring, pain and infection, the FDA said.

The FDA recommends that women who get silicone implants: follow-up regularly with their doctor, which includes occasional MRIs to detect potential ruptures; pay attention to any changes and notify their health-care provider if they notice any unusual symptoms such as pain, asymmetry or swelling; and educate themselves on the signs and symptoms of complications.

“It’s important to remember that breast implants are not lifetime devices,” Maisel said. “Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential.”

FDA OKs 3rd Silicone-Gel Breast Implant

Plastic surgeons react to breast-implant news – In Your Face : The Orange County Register

Plastic surgeons have mixed reactions to news of the FDA approving a new silicone-gel breast implant..The company, Sientra of Santa Barbara, says it plans to offer implants in various shapes in addition to the round implants now sold by Irvine-based Allergan and Johnson & Johnson’s Mentor unit.

Silicone-gel breast implants have been controversial for years. They went off  the market in the 1990s and came back in 2006. Manufacturers are now required to track the health and experiences of recipients.

You can read our original story here.

The reaction to the news is varied, but plastic surgeons tend to welcome  more competition among these products.

Dr. Dr. Eugene Elliott, cosmetic and reconstructive surgeon at Orange Coast Memorial Medical Center in Fountain Valley:

“I think it’s great that there is now a third company with FDA approved breast implants. Breast implants have been one of the most scrutinized medical devices by the FDA. The moratorium on silicone implants during the 90′s was based upon ‘junk science’. It was a very difficult time for our patients who were unnecessarily scared by the alleged adverse effects of their implants. The only positive outcome of the moratorium was the release of a better constructed implant in 2006.

“if the implants from Sientra will offer a choice of implant design that may enhance the results that we as plastic surgeons can offer our patients it will be a wonderful addition. if at worst the new implants are identical to the existing [products], healthy competition will likely benefit the patient. Healthy competition will lead to accelerated innovation and ultimately an improved product.”

Dr. John Di Saia, plastic surgeon in San Clemente and Orange:

“Shapes are attractive selling points … still as a surgeon I would not encourage patients to go with a product about which I know little to nothing over the alternatives with which I have nearly twenty years experience.”

[from his blog]:

“The real test of marketing for a new breast implant is the history after first ten or twenty thousand patients have had them placed and five to ten years have passed. so new implant products are kind of a ‘grey zone’ to me … a good warranty would be minimum to get me into the mood to try these new silicone breast implants unless for some reason patients insist.”

Dr. Terry Dubrow, plastic surgeon in Newport Beach:

“It’s great there is another breast implant manufacturer in the marketplace. What the last 15 years has certainly shown us is that silicone breast implants are a satisfying and highly successful cosmetic surgery procedure and if a patient is willing to risk complications like hardening and displacement they may be appropriate for many women. The introduction of a third supplier should drive prices down further.”

Dr. Anthony Youn, plastic surgeon and author in Michigan:

“This is a big deal in the plastic surgery field. Mentor and Allergan (aka McGhan) have been the only real players in the breast implant market for 20 years. although Sientra’s implants are now approved for use, their products remain unknown to the vast majority of plastic surgeons. Study results have not been publicly released (to my knowledge), and therefore how Sientra’s implants stack up to Mentor and Allergan’s is still in question.

“if Sientra’s implants test as well as the other two companies AND have a lower price, then we may see more and more women being able to afford breast augmentation.”

Did you miss?

12 plastic surgery trends for 2012

Latest from this blog:.

ADVERTISEMENT

you can follow any responses to this entry through the RSS 2.0 feed. you can skip to the end and leave a response. Pinging is currently not allowed.

Plastic surgeons react to breast-implant news – In Your Face : The Orange County Register

Faulty French Breast Implants May Upend U.S. Device Debate

February 02, 2012, 2:47 PM EST

By Alex Nussbaum, David Voreacos and Allison Connolly

(Updates with comment from congressman in 12th paragraph.)

Jan. 19 (Bloomberg) — Medical device makers have spent the last year urging U.S. officials to approve high-risk products faster, like their European counterparts. a scandal over leaking breast implants made in France may make the argument harder.

French and German officials last month recommended thousands of women have surgery to remove implants made by Poly Implants Protheses SA, after reports the products were leaking industrial silicone inside patients. the mishaps have heightened scrutiny of European Union rules for medical devices that already faced calls from doctors for an overhaul.

While the devices were never approved for use in the U.S., they may alter the debate over regulations there as well. Congress faces a September deadline over whether to revamp U.S. device rules, and industry allies in both parties have pointed to Europe’s speedier reviews as a model to follow. the tales of leaking implants, along with other EU device failures, should give lawmakers pause, said Carl Heneghan, an Oxford University teacher who has studied device recalls.

“All the industry guys in the U.S. say, ‘we should have access to these products much sooner, like in Europe,’” he said. “the flip side is, the European people are being used as guinea pigs.”

Heneghan, a physician who runs Oxford’s Centre for Evidence-Based Medicine, is among a growing chorus of doctors, regulators and even device makers calling for changes to Europe’s system, which relies on private reviewers hired by manufacturers to vet products. the European Commission is expected to recommend changes by the end of June.

‘Inevitable Result’

“the PIP breast implant scandal is an inevitable result” of regulators’ “paralysis and inability to correct the failings of a flawed system,” Richard Horton, the editor of the British medical journal the Lancet, said in an editorial released yesterday. European approval “does not guarantee safety.”

on the other side of the Atlantic, U.S. device makers have complained for years about slow reviews and inconsistent standards at the Food and Drug Administration. At the same time, the agency has faced criticism after high-profile recalls of technology it cleared for sale, from Johnson & Johnson hip implants to Medtronic Inc. defibrillators.

In a series of Capitol Hill hearings last year, industry supporters often cited the EU as a better model. its speedier reviews were luring companies away, taking “good-paying American jobs” with them, said Representative Joseph Pitts, a Pennsylvania Republican, in a typical warning last February. a Stanford University survey of manufacturers, released in 2010, found complex devices reach the EU two years faster on average.

“the industry is rapidly moving outside the United States,” said Steve Ferguson, chairman of Bloomington, Indiana- based Cook Group, the world’s largest closely held device maker, in a telephone interview. For American patients, “the human cost of not having access to that technology is enormous.”

the Cook Group, which had $1.9 billion in sales in 2011, once made 75 percent of its revenue in the U.S. That fell to 44 percent last year thanks in part to lower taxes and faster reviews in the EU, he said.

More than a dozen bills have been introduced to rewrite FDA rules. “You can carry this business of safety to a ridiculous level,” Representative Phil Gingrey, a Georgia Republican who sponsored one of the proposals, said in an interview last month before the European governments recommended removal of the PIP implants. “We’ve got to be responsible and safe, but we’ve got to understand that you can completely price these innovators out of the market.”

Life-Saving Treatments

Gingrey, in an e-mail today, said, “We must do everything in our power to prevent instances like those in France from occurring. on the other hand, we must also do everything possible to prevent the FDA from standing between patients and life-saving treatments.”

the debate may reach a climax this year, said Ira Loss, an analyst at the investment research firm Washington Analysis. Congress faces a Sept. 30 deadline to renew industry fees that fund device reviews. the legislation is expected to become the arena for a broader fight over whether to push for quicker approvals, said Loss, an FDA watcher for three decades.

unlike the FDA’s government-run reviews, the EU relies on a decentralized network of about 70 “notified bodies.” the closely held, mostly for-profit firms are hired by companies to check their products. the reviewers must be accredited by one of the union’s 27 member nations. Approval by any one of them allows companies to sell a device throughout the EU.

Safe and Effective

There’s another key difference, Oxford’s Heneghan said in a telephone interview. While the EU and U.S. require manufacturers to prove new products are safe, only the FDA mandates they also show devices are effective. That means studies for European approval are typically less in-depth than those required in the U.S, Heneghan said.

the European system sets up “an inherent conflict of interest” where companies can shop for the most amenable reviewers, said Deborah Cohen, an editor at the London-based British Medical Journal, which publishes drug and device research. In may, the 70,000-member European Society of Cardiology also called for changes, writing in its journal that notified bodies need higher standards and more transparency.

the Poly Implants Protheses breast implants were cleared by TUEV Rheinland, a notified body based in Cologne, Germany. TUEV Rheinland said in a Dec. 29 statement that its inspectors had been misled when PIP substituted industrial silicone for a medically approved variety after an inspection. following EU device rules, the manufacturer had been told in advance about the inspection, TUEV said.

Implants with industrial silicone are more likely to rupture, leaking a gel that can cause scar tissue and inflammation, the French Health Ministry said in a Dec. 23 statement. the silicone is more typically used to make mattresses, the British Association of Aesthetic Plastic Surgeons said in its statement Dec. 3. PIP sold more than 300,000 of the implants during the past 12 years, mainly in Spain and the U.K., the group said.

the case underscores the need for changes in Europe’s system, said John Brennan, regulatory-affairs director at device industry trade group Eucomed. the Brussels-based association supports the creation of a central advisory committee to hold notified bodies to more consistent standards, he said. Approval and recall data also should be more accessible.

“People expect to know about the products that are being put in their bodies,” Brennan said in an interview. “We should have the equivalent transparency as the U.S.”

PIP, based in Toulon, France, was liquidated in March 2010 after French authorities banned the company’s implants. Yves Haddad, an attorney for company founder Jean-Claude Mas, didn’t respond to messages left at his office in Toulon.

the implants are the latest example of devices that reached Europe’s market too quickly, said Cohen, the British Medical Journal editor. In 2007, Dublin-based Covidien Plc won EU approval for PleuraSeal, a sealant designed to help doctors plug tiny holes in the lungs after surgery. a follow-up trial to win U.S. approval found three times as many patients developed air leaks with PleuraSeal than with sutures, Covidien said in a statement. the product, which never reached American patients, was recalled worldwide in October 2010.

the FDA, in a memo to Congress last year, cited more than a dozen other categories of “problematic devices” that reached Europe but never won U.S. approval. along with PIP’s products, the list included inaccurate blood-sugar monitors, ineffective heart stents and an aortic graft linked to blood clots.

Covidien introduced PleuraSeal in the EU because it felt the market there was more attractive, Bruce Farmer, a spokesman, said in an e-mail. “Our commitment to patient safety cannot be compromised,” he said. “All of our products meet or exceed the safety requirements of the market where they are sold.”

last January, an industry-sponsored study by the Boston Consulting Group found little difference in the number or severity of recalls in the two systems, suggesting the EU’s speedier approvals don’t sacrifice safety. the FDA and Oxford’s Heneghan questioned the report, saying a lack of disclosure and differing definitions of recalls in Europe make it impossible to draw meaningful conclusions.

the study “made assumptions that all serious problems are being reported” and “then did an extrapolation to come up with a number,” said Jeffrey Shuren, director of the agency’s device-review center, in an interview. “It’s just not a good measure of safety.”

the FDA, while acknowledging industry concerns about U.S. regulation, defends its system as better for patients. the European process makes it impossible to track approvals, side effects or recalls, Shuren said. unlike in the U.S., there’s no central website where the public can find reports of adverse events or product withdrawals, he said.

Notified bodies often lack the expertise the FDA has gained after years of checking thousands of devices, Shuren said.

“the answer at the end of the day isn’t to scrap the U.S. standard of safety and effectiveness,” Shuren said. “the answer is to keep the U.S. standard but let us do our job to improve the program.”

–With assistance from Albertina Torsoli in Paris. Editors: Rick Schine, Andrew Pollack

To contact the reporters on this story: Alex Nussbaum in New York anussbaum1@bloomberg.net; David Voreacos in Newark, New Jersey, at dvoreacos@bloomberg.net; Allison Connolly in Frankfurt at aconnolly4@bloomberg.net

To contact the editors responsible for this story: Reg Gale at rgale5@bloomberg.net; Michael Hytha at mhytha@bloomberg.net; Phil Serafino at pserafino@bloomberg.net.

Faulty French Breast Implants May Upend U.S. Device Debate

Leeches are making a comeback as medical helpers

BALTIMORE – Marc Miller survived a motorcycle crash in Octobernear his Baltimore County, Md., home, but his foot had been draggedalong the pavement and badly damaged. That injury would requireboth the most advanced medicine and an ancient therapy -leeches.

Trauma doctors at Johns Hopkins, the University of Maryland andother U.S. hospitals routinely use leeches as a temporary measureto keep blood flowing as new vessels grow in a damaged area. Theanimals kept blood moving in and out of a new skin flap sewn ontoMiller’s foot. They also can get blood flowing to amputated digitsthat are reattached. and because the leeches’ saliva has a naturalanesthetic, some doctors now are looking to use them to easepain.

“They can be the difference in whether the tissue lives or dies,”Dr. Scott D. Lifchez, who treated Miller and is section chief ofplastic surgery at Johns Hopkins Bayview Medical Center, said aboutthe blood-sucking worms.

The U.S. Food and Drug Administration gave its approval to marketleeches as medical devices in 2004, though they had been used formany years before then. and their use appears to be growing, saidDr. Ronald A. Sherman, director of the BioTherapeutics, Educationand Research Foundation, which supports the medical use of leechesand other furry, slimy and microscopic animals.

Guide dogs may be the best-known in the category, said Sherman. Butothers, particularly leeches and maggots that clean wounds, aregaining in popularity. Maggots are used more than 50,000 times ayear worldwide, he said.

As for the use of leeches, Sherman said there is no registry orcertification board for physicians in the United States, so no onecan say how often they are used for medical purposes. at an annualconference hosted by his group, seminars on leeches drew 100medical professionals last year, more than any other year.

“In other countries, use of leeches has been ongoing for centuries,but in the United States, I would call it a comeback,” saidSherman, a retired University of California researcher. “Theintroduction of leeches for draining blood occurred in the late1970s, maybe early ’80s, but my perception is that it’s gettingmore known.”

Records of the use of leeches in medical treatment stretch backmany centuries – to a painting in an Egyptian tomb around 1500 BC,according to one study in a medical journal. Bloodletting therapieswere popular in Europe during the 17th and 18th centuries,triggering shortages of the animals in some countries. later, asmedical science advanced and bacteria became the focus oftreatment, the use of leeches faded. But in the 1970s, their usewas revived in microsurgery, the study noted.

Sherman said the primary use today is draining congested blood indamaged appendages or skin flaps. the leeches have a naturalanticoagulant that breaks up small clots and keeps new ones fromforming. That allows pools of blood to drain and keeps bloodflowing freely until new vessels connect.

Doctors direct the blood-suckers to a specific site – Dr. Lifchezuses Vaseline and gauze to nudge them into place. They draw bloodfor about 15 minutes and fall off once they are full.

The alternative might be losing the appendage or having a morecomplicated surgery, said Sherman, who also notes the leeches arerelatively inexpensive – Carolina Biological Supply Co., one of twoU.S. suppliers, sells a 2-to-4-inch leech, Hirudo medicinalis, for$19.50. (Includes instructions. Sold only to schools andbusinesses, company marketing materials say.) Leeches USA Ltd.sells them for less than $10 when purchased in bulk. the companiesdo not release sales information.

Some patients ‘a little grossed out’

At Maryland Shock Trauma Center, where many of the worst accidentsand injuries in the region are treated, leeches are employedseveral times a year, said Caroline Connolly, a veteran nurse whoworks with them.

She said the leeches have been around for about 15 years and areused when blood isn’t circulating well after a “free tissuetransfer” – when a flap of skin, and possibly muscle, fat, vesselsand even bone are moved from one part of the body to replace whatwas lost in the wounded area.

Even though these are medical leeches, grown in sterileenvironments, many patients are still “a little grossed out,” saidConnolly. she said she only needs to tell the patients howsuccessful the leeches are.

And the alternative is another long and complicated surgery to tryanother skin flap or amputation of damaged extremities. Connollysaid leeches have been used to help rebuild faces blown apart bygunfire, but mostly they are used for car and motorcycle accidentvictims, such as Miller.

Leeches to the rescue

Lifchez used a leech every six to 12 hours on Miller overseveral days while he was in the intensive-care unit. There, nursescould watch over him and the animals. Miller said sometimes he’dalert the staff when a leech was done feeding so it could beproperly disposed of.

Circulation problems arise in up to a quarter of cases of freetissue transfer, and the wound can benefit from leeches, Lifchezsaid.

It was a day or so after Miller’s 10-hour operation in October toplace the new skin flap – which included some fat and vessels -when it began to look a little purplish.

Lifchez and another surgeon checked to make sure the suturesweren’t too tight and the vessel connections were properly done.But still the blood wasn’t flowing properly. They did not want tolose the foot, a likely prospect just a couple of decadesago.

The leeches arrived by overnight delivery.

Faced with amputation or more surgery, most patients are receptiveto being treated with leeches, Lifchez says. Miller, who had oncewanted to be a veterinarian, and his mother, Delores Williams, whois a nurse, both knew about leeches’ abilities and didn’t need anyconvincing.

“I remembered what leeches were capable of doing,” said Miller,who expects to shed his wheelchair and crutches in the spring andbegin the process of relearning to walk. “I feel fortunate to havemy foot. I feel very positive now.”

Lifchez said circulation is normal in Miller’s skin now. he mayneed another procedure to remove some fat transferred with theskin, making his foot bulge a bit. That would make it easier forhis foot to fit in a shoe.

For now, Miller will remain at home supervised by his mother,who is thankful for the Hopkins team that saved her son’s foot -and for Miller’s declaration that his motorcycle days over.

Leeches are making a comeback as medical helpers

Choosing Plastic Surgery Or Breast Augmentation is a Serious Decision

Thousands of women choose it every day but they must put in some study time to be certain this is actually what they want to do. We are talking about plastic surgery and specifically breast augmentation. It has become one of the leading requests in the field of plastic surgery. Whether its called augmentation mammaplasty, breast implants, or breast augmentation surgery the procedure involves inserting medical devices. They may consist of either saline breast implants which are filled with salt water or silicone breast implants which are filled with elastic gel like material. They are inserted under the skin and behind existing breast tissue to enlarge the breast overall and give the appearance of fuller breasts.

Why do women want breast implants?

There are many reasons a woman chooses to have breast augmentation surgery. She may feel her breasts are simply not large enough to be attractive or she might have had a baby and found her original size had diminished. other reasons include restoring breast volume or size after losing a substantial amount of weight due to dieting. Breast implants can also be desired after breast cancer surgery.

Make the decision with your doctor’s advice

Patients who desire to have breast augmentation plastic surgery need to give it some serious thought because it is a major decision with long reaching effects. Many women want their breasts enlarged because they feel inadequate or less of a woman by having small breasts. Their feelings must be evaluated and a doctor can determine if his patient is mentally qualified for this elective surgery. there may be other underlying reasons she feel inadequate and simply having plastic surgery may not help her. Family history involving breast cancer or biopsies results, mammograms, or prior surgeries may preclude her from having breast augmentation surgery performed. your surgeon will examine both breasts and take measurements regarding size, placement of the nipples, and skin integrity.

After plastic surgery results will be evaluated

Many women find they love how they look in clothing and bathing suits, giving them a boost in their self confidence they much needed. the surgeon needs to advise his patient that she will need to return for routine visits because the breast augmentation is not permanent and replacements may be required over time. Many women need to have their implants replaced after years because they’ve undergone hormonal changes, lost weight, or just are no longer satisfied with her appearance.

Cost of surgery and how about insurance coverage?

Cost involved in breast augmentation plastic surgery will vary by several factors. Experience of the surgeon and the region you live in and wish to have the surgery performed play a large part in determine cost. the type of anesthesia, whether the surgery is to be done in the doctors office or in hospital, and the type of implant to be used are other deciding factors. Typically breast augmentation cost includes the implants themselves which run from four thousand to over ten thousand dollars each. Anesthesia will run from six to eight hundred on average and use of the facility will cost around eight hundred to over twelve hundred. Surgeons fees are largely dependent on their level of expertise and the area in which they practice. As this is an elective surgery some insurance companies do not provide coverage.

Choosing Plastic Surgery Or Breast Augmentation is a Serious Decision