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Cancer Scare Over Breast Implants Triggers Recall Moves and Court Actions

by Gopalan on December 22, 2011 at 6:10 AM
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 Cancer Scare Over Breast Implants Triggers Recall Moves and Court Actions

As the panic over possible cancer development from breast implants spreads, the French government could suggest removal of the implants manufactured by the now-bankrupt French firm Poly Implant Prothese (PIP).

While 30,000 French women have had the PIP implants, at least eight cases of cancer, mainly breast, have been reported there.


France's health ministry however has said there was no "urgent health risk" from the implants and no "causal link" with cancer has yet been proved.

More than 250 British women are taking court action after more than half experienced ruptures in their breast implants.

In Australia, where 4500 have had a PIP device inserted between 2004 and last year are being counselled not to panic, but advised to report to a national register so that their health may be monitored.

Doctors there would try to ascertain if there is a link between any type of breast implant and a rare form of cancer called anaplastic large cell lymphoma or ALCL.

Documents obtained on Wednesday showed that tens of thousands of women in more than 65 countries, mainly in South America and western Europe, received implants produced by PIP, which ceased trading last year, AFP reports.

An expert report will be released in France on Friday saying whether the implants should be removed.

A lawyer representing more than 250 women in Britain said legal proceedings would start next year, with the complainants making claims against the clinics which carried out the operations to insert the implants.

"Over half of these women have suffered ruptured implants and we are also representing other women who are worried by the reports of problems and worried that their implants could rupture eventually," lawyer Esyllt Hughes said.

"We have issued some court proceedings and we expect them to begin in Cardiff next year."

PIP was shut down and its products banned last year after it was revealed to have been using non-authorised silicone gel that caused abnormally high rupture rates of its implants.

Facing financial difficulties, the company, once the world's third-largest producer of silicone implants, replaced the medical-grade silicone in its implants with industrial-strength material.

Prosecutors in Marseille, near the firm's home base of Seyne-sur-Mer, have received more than 2,000 complaints from French women who received the implants and have opened a criminal investigation into the firm.

The Medicines and Healthcare products Regulatory Agency (MHRA) in Britain urged patients not to panic, although it said they may want to consult their surgeons.

"We did extensive genotoxic and chemical tests and we could find no evidence of any safety aspect associated with this filler," MHRA medical director Suzanne Ludgate told BBC radio.

The Australian Society of Plastic Surgeons too said that given an estimated 5 to 10 million women had had implants globally, women should not panic about the risk, but rather talk to their doctors and, if necessary, have their implants checked.

If an implant ruptured, it could cause breast tissue to become lumpy and deformed, but there was no evidence to suggest a rupture would cause cancer.

A spokesman said about 80 cases of the cancer in women with implants had been reported worldwide, including seven in Australia.

In many cases, the cancer was found in scar tissue around implants after women complained of pain in their breasts. The implants in those affected included both saline and silicone varieties. ALCL is estimated to affect about one in 500,000 women each year.

In a statement about the possible link this year, the US Food and Drug Administration said it did not believe the risk was high enough to recommend implant removals as a protective measure.

''The FDA believes that women with breast implants may have an increased risk of developing ALCL, but also believes any potential risk is extremely low,'' the statement said.

''Due to the rarity of ALCL, the small number of reports, and the incomplete and limited data from these reports, more information is needed to fully understand the possible link between breast implants and ALCL.''

A spokeswoman for Australia's medical watchdog, the Therapeutic Goods Administration, said tests on PIP implants had previously found them to comply with regulations and she said there had been 45 reports of problems with them, including 39 ruptures.

She said there had been no cases of ALCL in women with the PIP implants in Australia and urged anyone with concerns to consult their treating surgeon.

There too legal action could be on the cards, it is reported.

Source: Medindia

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