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New Study Reveals PIP Breast Implants High Failure Rate

A new research conducted by British doctors suggests that the rate of failure of PIP silicone breast implants could be up to 33.8 percent, which is significantly higher than the 2 percent to 5 percent failure rates usually reported by previous studies.

Under the new study, researchers examined patients who had PIP implants for primary/secondary breast augmentation from January 2000 to August 2005 in order to determine the rate of failure and other complications. The study found that PIP implants’ failure rate could range from 15.9 percent to 33.8 percent.

Most of the earlier researches typically used clinical examination and were based on multiple technique, multiple surgeon, with small number of study participants and shorter follow up time period. with the new study, all patients were scanned with ultrasound, providing conclusive sign of rupture, said lead authors Miles Berry and Jan Stanek, whose work appeared in the Journal of Plastic, Reconstructive and Aesthetic Surgery.

PIP silicone implants were formally recalled in the UK market two years ago due to concerns on its durability. There have been also concerns on the filler gel and outer cover of the breast implant called elastomer.

For the new study, plastic surgeons used PIP implants for secondary and primary breast augmentation. They then created a database of patients, who were offered a consultation for free and referral for ultrasound scan. Among the major outcome measures were implant rupture rate, time to rupture and secondary surgery.

The researchers identified 453 patients with PIP implants, 30 of whom had already gone through implant exchange. One hundred eighty patients or 39.7 percent could not be reached and 19 had gone through implant removal. Forty-seven of the patients who were contacted refused consultation for they didn’t have any concern. Ninety-seven patients had neither radiographic evidence nor clinical signs of rupture and chose to stay under regular review, while 38 had gone through implant exchange following ultrasonographic sign of rupture.

Given that those who could not be contacted had no ruptures, the overall rate of rupture would stand at 15.9 percent. But if they had the same rate of rupture as the patients examined in the research, the overall rate would reach 33.8 percent.

With these findings, researchers suggest that all PIP silicone breast implants may have to be removed due to the high rate of rupture and the uncertainty on the nature of the gel. Implants among patients with rupture will have to be removed, while those without evidence of rupture will have to be monitored regularly. on the nature of the gel filler and elastomer, further study may still be needed to determine if there is a need to explant all PIP implants in the future.

This initial research is just the tip of the iceberg that may affect 40,000 women with PIP breast silicone implants in the UK. More than 400,000 women worldwide are estimated to have received PIP implants.

New Study Reveals PIP Breast Implants High Failure Rate

Made of Tissue or Silicon, Breast Implants Require a Lifetime of Care

Women around the world are worried about implants from a now-defunct French company, but all products need to be watched carefully.

BreastImplantsReuters-Post.jpg

The Internet and women’s magazines are filled with enticing adverts for breast implant surgery, but experts and regulators have varying views on how long they last and possible risks.

The implants now at the center of a worldwide health scare came from the now-defunct French company Poly Implant Prothese (PIP) and appear to have an abnormally high rupture rate. That risk, though typically low, is present in all implants.

Breast implants have been on the market since the early 1960s, after the first implants were developed by two plastic surgeons in Texas working with the silicone specialist firm Dow Corning Corporation.

The first woman to have silicone breast implants was in 1962 in the United States. Since then, between five and 10 million women worldwide, including an estimated 1.5 million to 2.5 million in the United States, have had breast implant surgery.

Although silicone implants are considered the more natural-looking option because they are more likely to appear and feel like real breasts, safety concerns have dogged them for years.

Modern devices are likely to last between 20 to 25 years, about 10 years longer on average than the older types developed in the early 1960s and 1970s.

SILICONE OR SALINE

In 1992, the U.S. drugs regulator, the Food and Drugs Administration (FDA), decided silicone implants should be taken off the domestic market because their safety had not been fully established.

But U.S. silicone implant sales resumed in 2006 after the FDA approved implants sold by Allergan and Johnson & Johnson’s Mentor unit on condition that the companies would follow a sample of 40,000 women for 10 years to look at safety issues.

In Britain, breast enlargement is the most common cosmetic surgery performed on women, the Medicines and Healthcare products Regulatory Agency (MHRA) said. the operation is also hugely popular in Latin America. In Brazil, some 200,000 to 300,000 breast implant operations are carried out each year, according to the Brazilian Plastic Surgery Society.

Several types of implant are available, including those constructed from natural tissue taken from elsewhere on the body. This type of surgery is more usual in breast cancer patients undergoing breast reconstruction after a mastectomy.

More common implants used in cosmetic surgery are silicone- or saline-filled devices which are placed under the breast tissue to boost size and enhance shape.

The implants are usually inserted via an incision under the breast, but can also be put in using a cut in the armpit or around the nipple. the operation is generally done under general anesthetic and takes up to one-and-a-half hours.

NO LIFETIME GUARANTEE

Experts warn, however, that breast implants are likely to need long-term care. ”Breast implants do not last a lifetime, they will need replacing at some point in the future,” the British Implant Information Society says on its website. it says modern devices are likely to last between 20 to 25 years, about 10 years longer on average than the older types developed in the early 1960s and 1970s.

In some countries where implants are popular among very young women — in Venezuela it is not unusual for parents to give breast implant surgery to teenage daughters as gifts — this could mean a woman going back once and possibly twice in a lifetime for more breast surgery.

Doctors say pain is frequent after surgery, and most clinics advise patients not to raise their arms above their heads for several weeks after the operation. the MHRA lists other potential problems, such as the risks of infection, leakage or bleeding, possible creasing and kinking of the breast tissue, and temporary loss of sensation.

U.S. regulators warned this year that most women with implants were likely to need additional surgery within 10 years to address complications such as rupturing and leakage, two of the main problems associated with the PIP devices.

All this suggests the costs of breast enhancement surgery are likely to add up over the years. According to one U.S. cosmetic surgery price guide, breast implant surgery with either silicone or saline implants can cost between $5,000 and $8,000, similar to costs in Britain.

So-called “revision” breast surgery is often more expensive, lengthier, and more complicated than the first time around because of existing scar tissue and the need to remove or adjust the original implants. Anyone offering significantly lower priced surgery may be cutting corners on aftercare or follow-up consultations, experts say, and patients should beware.

Image: Eric Gaillard/Reuters.

<a href="http://www.theatlantic.com/health/archive/2011/12/made-of-tissue-or-silicon-breast-implants-require-a-lifetime-of-care/250567/tag:news.google.com,2005:cluster=http://www.theatlantic.com/health/archive/2011/12/made-of-tissue-or-silicon-breast-implants-require-a-lifetime-of-care/250567/Wed, 28 Dec 2011 18:00:12 GMT”>Made of Tissue or Silicon, Breast Implants Require a Lifetime of Care