Gender targeting by (sometimes criminal) medical device industry? Breast implants, birth control, transvaginal surgical mesh?

Maker of faulty French breast implants given fouryears in jail

BY JEAN-FRANCOIS ROSNOBLET AND ALEXANDRIA SAGE

MARSEILLE/PARIS Tue Dec 10, 2013 8:00am EST Reuters FiDA highlight

(Reuters) - The founder of a French breast implant company was sentenced to four years in prison on Tuesday for hiding the true nature of the sub-standard silicone used in implants sold to 300,000 women around the world.

Jean-Claude Mas, 74, founder and long-time chief executive of Poly Implant Prothese (PIP), was prosecuted after a worldwide panic in 2011 when France recommended that women with such implants should have them removed due to an abnormally high rupture rate.

Worries about the implants launched a flurry of international lawsuits and prompted calls for Europe to toughen controls on medical devices and fix its fractured oversight system.

Once the third-largest global supplier of breast implants, the company was shut in 2010 and its implants ordered off the market after inspectors pursuing a tip-off discovered vats of industrial-grade silicone outside the PIP factory in the southern town of La-Seyne-sur-Mer.

A Marseille criminal court also ordered Mas, who had been pursued for aggravated fraud, to pay a 75,000-euro ($103,000) fine. His lawyer, Yves Haddad, said he would appeal.

Four other executives, including the chief financial officer, were sentenced to between one-and-a-half and three years in prison, some of it suspended, and fined.

"It's a strong signal. This decision is what victims were waiting for," said one of their lawyers, Philippe Courtois.

The president of a PIP victims group, Alexandra Blachere, called it a "symbolic sentence" that challenged any prejudice that there was "a ditzy bimbo behind every pair of silicone breasts."

The two-month trial in April and May was held in an exhibition center to accommodate the 7,400 civil plaintiffs and 300 lawyers. Jeers from the crowd greeted Mas' appearance in the makeshift courtroom.

For less serious felonies in France, the criminal court hands down a sentence without pronouncing a guilty or not guilty verdict, which is implicit.

HIDDEN EVIDENCE

Mas admitted using silicone created by trial and error that was never approved by regulators and which cost a seventh of the price of silicone approved for use in medical devices.

He has insisted the gel he had relied on since the founding of the company in 1991 was non-toxic and has said women who complain about their PIP implants are "fragile people, or people who are doing it for the money."

A police investigation revealed a sophisticated fraud at PIP, which managed to conceal the implants' ingredients from regulators, thereby allowing them to be sold on international markets.

Before annual audits to the PIP factory by private certification company TUV Rheinland, employees would clear away evidence of the cheaper gel it used to fill implants.

For a special report on the PIP scandal, click here:

TUV sued PIP for fraud, but a French court ruled last month the German company had failed in its obligations of "vigilance and caution" and ordered it to pay 3,000 euros to each of the 1,600 plaintiffs, women wearing PIP implants who had sued.

Health experts insist that no link has been established between PIP implants and breast cancer.

Still, women around the world with PIP implants, whether in Venezuela, France or Britain, have rushed to their surgeons to have them removed, fearing health complications.

Since France recommended removal, some 14,729 women in France - nearly half of all French women with PIP implants - have chosen this option, according to French regulators.

Regulators say a quarter of PIP implants removed were found to be faulty, most having ruptured.

Only one case of anaplastic large cell lymphoma, a rare type of cancer originating in the lymphatic system, has been documented in France from a women wearing PIP implants.

National health agencies have given differing advice. While France and Venezuela offered to reimburse women who have their PIP implants removed, other countries, such as Britain, recommended that women merely have them checked.

Other legal cases related to PIP are still pending in France, including one related to the 2010 death of a woman wearing PIP implants. Another relates to tax fraud by Mas, his former girlfriend and Chief Executive Claude Couty.

(Writing By Alexandria Sage; Editing by Mark John and Ruth Pitchford)

Women: Hip Implants 29% More Likely to Fail

Hip Implants More Likely to Fail inWomen

By John Gever, Senior Editor, MedPage Today

Published: February 18, 2013

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco

Failure rates for hip implants were 29% higher for women than men in a large U.S. registry study after controlling for a variety of factors including device type, researchers said.

With a total of 35,140 patients undergoing primary total hip arthroplasty followed for a median of 3 years, the crude all-cause rate of failure (defined as subsequent revision surgery) was 2.3% for women (95% CI 2.1% to 2.5%) compared with 1.9% for men (95% CI 1.6% to 2.1%), according to Maria C.S. Inacio, MS, of the Southern California Permanente Research Group in San Diego, and colleagues.

After adjustments for age, body mass index, diabetes status, degree of presurgical symptom severity, implant fixation method, device category, and femoral head size, the authors calculated a hazard ratio (HR) for revision of 1.29 for women versus men (95% CI 1.11 to 1.51), they reported online in JAMA Internal Medicine.

The risk appeared most prominent for aseptic revision (HR 1.32, 95% CI 1.10 to 1.58) compared with septic failure (HR 1.17, 95% CI 0.81 to 1.68), the researchers found.

Larger femoral head sizes appeared especially problematic for women. For head sizes of 36 mm or more, the adjusted HR for failure in women versus men was 1.49 (95% CI 1.14 to 1.95), whereas differences in revision rates for smaller head sizes were not significant after adjustment.

Much of the increased risk for women also seemed concentrated in metal-on-metal implants, with a doubling in risk for women versus men (adjusted HR 1.97, 95% CI 1.29 to 3.00).

But that was primarily because of reduced risk of failure with metal-on-metal devices in men (adjusted HR 0.68 versus highly crosslinked polyethylene, 95% CI 0.45 to 1.02), whereas in women, the adjusted failure rates for metal-on-metal versus crosslinked polyethylene were similar, adjusted HR 1.07, 95% CI 0.72 to 1.60).

Clinical Implications?

In an accompanying commentary, Diana Zuckerman, PhD, of the National Research Center for Women and Families in Washington, D.C., suggested that the study's clinical implications were relatively trivial.

She noted that most patients considering hip replacement are already suffering pain and limited mobility and have few other options.

"Knowing that their chances of success are lower than men's is not helpful to women who are unable to perform many activities of daily living," Zuckerman argued.

Instead, she said, what is needed is "long-term comparative effectiveness research based on large sample sizes, indicating which total hip arthroplasty devices are less likely to fail in women and in men, with subgroup analyses based on age and other key patient traits, as well as key surgeon and hospital factors."

But Glenn Don Wera, MD, of UH Case Medical Center in Cleveland, told MedPage Today that the study provided valuable insights into the reasons for higher failure rates in women.

He noted that the higher rate of revision in women was already known from Medicare data. In the current study, however, "they were able to control for a number of clinical factors, including the kind of prosthesis the patient had, the experience level of the surgeon, and the different institutions and the different prostheses they were using."

That the increased risk in women was still evident despite adjusting for those factors indicates that something else, such as women's generally smaller stature, is responsible, Wera suggested.

Revision Rate: Beyond Infection

Data for the current study came from the Kaiser Permanente system's registry of total joint replacements from 2001 to 2010. Procedures were performed at 46 hospitals in California, Hawaii, Oregon, Washington, and Colorado by 319 different surgeons.

The registry is the largest of its type in the U.S., the authors said and includes data on surgeons' and hospitals' arthroplasty procedure volumes; the patients and the implants they received (cemented, uncemented, or hybrid); and implant bearing surface, such as metal on metal, metal or ceramic on highly crosslinked polyethylene, or ceramic on ceramic. The researchers put the DePuy metal-on-metal hip resurfacing monoblock device into its own category.

Only patients undergoing unilateral procedures were included in the analysis.

About 58% of the 35,140 procedures were performed in women (mean age 65.7 versus 63.8 for men). Just over 60% of both sexes had scores of 1 or 2 on the American Society of Anesthesiologists index, with nearly all of the remainder having scores of 3 or more.

The age difference between men and women was statistically significant. In addition, women in the cohort tended to be slightly more likely to be white or Asian and to have osteoarthritis, rheumatoid arthritis, or dysplasia. They were less likely to be diabetic or obese and to have osteonecrosis or post-traumatic arthritis.

Not surprisingly, women were much less likely to have implant femoral head sizes of 36 mm or more (32.8% versus 55.4% for men, P<0.001). About twice as many men as women had metal-on-metal bearings (19.4% versus 9.6%), whereas ceramic or metal on highly crosslinked polyethylene were more popular for female patients (P<0.001).

The DePuy resurfacing implant was used in 1.3% of women versus 2.6% of men (P<0.001).

Preferences for fixation types also differed between men and women, with hybrid methods more common in the women and cementless fixation more common in men.

Mean surgeon and hospital volumes did not differ between sexes.

The authors noted that with no significant increase in risk of septic failure for women, their results mean that "factors other than infection" are responsible for the higher overall revision rate.

Limitations to the analysis include its observational design, the relatively short follow-up period, lack of data on some potential confounding factors, and the use of revision surgery as the definition of implant failure. Also, the researchers used relatively broad categories of implant type, conceding that design variations within these categories could have influenced the results.

The study was funded by the FDA.

Study authors and Zuckerman declared no relationships with commercial entities. Several study authors were Kaiser Permanente employees.

Primary source: JAMA Internal Medicine
Source reference:
Inacio M, et al "Sex and risk of hip implant failure: Assessing total hip arthroplasty outcomes in the United States" JAMA Intern Med 2013; DOI: 10.1001/jamainternmed.2013.3271.

Additional source: JAMA Internal Medicine
Source reference:
Zuckerman D "Hip implant failure for men and women: What and when we need to know" JAMA Intern Med 2013; DOI: 10.1001/jamainternmed.2013.19.