Poly Implant Prothèse (PIP) Breast Implant Litigation Lawsuit

Poly Implant Prothèse (PIP) Breast Implant Litigation

• Type: Product-safety scandal / product liability (implants)

• Country: France, with worldwide reach

• Resolved: 2010 (recall by French health authorities)

Product and manufacturer

Poly Implant Prothèse (PIP) was a French medical-device company founded in 1991 by Jean-Claude Mas, a former medical sales representative. PIP manufactured pre-filled silicone gel breast implants and, over roughly two decades, became one of the world's largest implant makers, with most of its output sold outside France — in Western European markets such as the United Kingdom, Germany, Spain and Italy, in Australia, and across Latin America. The implants were used almost exclusively for cosmetic augmentation rather than reconstruction.

The defect

After the U.S. FDA suspended the sale of silicone breast implants in the American market in 2000, PIP moved to cut costs. Beginning in 2001, the company manufactured the majority of its implants using in-house, industrial-grade silicone instead of approved medical-grade gel. The industrial materials involved were the same class of compounds used in fuel additives and industrial rubber tubing. The in-house gel cost a small fraction of the price of authorized gel, and the substitution produced only superficial differences in the finished device. No regulatory approval was sought for the in-house product and no pre-launch testing was conducted. Post-recall inspections of the manufacturing site found that unapproved industrial silicone had been used in production. In some markets, the devices had been resold under a different trade name, "M-implants," which complicated patient identification.

Alleged harm

The central problem was an unusually high rate of rupture and gel leakage. French regulators reported rupture rates several times higher than for approved implant models, with patient groups citing figures as high as ten percent, while a United Kingdom audit of more than four hundred patients found that a substantial share of PIP implants had ruptured — in contrast to failure rates below one percent for other devices. Rupture and leakage were associated with inflammation, lumps, and hardening of breast tissue. Concerns intensified in late 2011 after the death of a French woman from anaplastic large-cell lymphoma (ALCL) developing in the scar capsule around a PIP implant. French health authorities also registered a number of breast cancers in women who had the implants, while stating that no causal link with the devices had been established.

Recall and resolution

The crisis became visible in 2009, when French surgeons reported abnormally high rupture rates and complaints began to multiply. In 2010, France's medical-products safety agency, AFSSAPS, ordered a full recall of PIP implants, and that March the company was placed into liquidation. In December 2011 the French government recommended that the roughly thirty thousand French women with PIP implants consider removal, with public funds covering removal procedures and follow-up screening.

International response

The scandal prompted coordinated action across jurisdictions. The United Kingdom estimated that thirty to forty thousand women were affected; NHS officials offered examinations and, where a surgeon judged it necessary, removal, and private clinics were urged to do the same. Germany recommended precautionary removal, while Sweden, Brazil, Argentina, Chile, Colombia and others banned the devices. In the United States, where the implants had been sold through a distributor until the 2000 moratorium, dozens of product-liability and contract claims were filed between 1996 and 2009, most of which did not proceed to trial. In Colombia, patients brought claims against the state health regulator for having authorized the devices and against the clinics that placed them without full disclosure of the quality deficiencies.

Aftermath

In 2013 criminal proceedings in France were brought against the founder and several company executives on fraud-related charges, and patient associations in France, Britain and Latin America pursued civil claims on behalf of implanted women. Litigation also extended to the German certification body that had audited PIP's production process; claims against it alleged that its annual inspections had failed to detect the unapproved silicone. In the wake of the scandal, UK and European regulators reviewed the adequacy of post-market surveillance for cosmetic implant devices.