Johnson & Johnson Unit Sued Over Leaking Breast Implants

  • California woman says silicone devices causing health woes
  • Silicone implants were frequent targets of suits 20 years ago

A Johnson & Johnson unit is allegedly selling defective breast implants that are causing health problems for some women, including muscle pain and nausea, according to the first state-court lawsuit in California over the devices.

J&J’s Mentor Worldwide unit failed to conduct proper studies of its silicone-based implants’ health risks that were mandated by government regulators, lawyers for Rexine Mize said in the suit filed Thursday in Los Angeles. Leaks from the devices are causing a variety of ailments for Mize and other women, she says in the complaint.

Ernie Knewitz, a spokesman New Brunswick, New Jersey-based J&J, didn’t immediately return calls on Friday seeking comment on Mize’s suit.

Mentor, Allergan Plc and Sientra Inc. are the only companies currently authorized by the U.S. Food and Drug Administration to sell silicone implants in the U.S. after the agency lifted a 14-year ban on the devices in 2006. The breast-implant market was about $635 million last year, with 80 percent of women opting for the silicone-based version, according to the American Society of Plastic Surgeons.

Mize’s case may be a harbinger of another wave of silicone-implant suits, said Jaime Moss, a Los Angeles lawyer who filed the case against J&J. The devices were a frequent target of litigation in the 1980s and 1990s and prompted some companies to seek bankruptcy in an attempt to resolve claims.

Pervasive Problem

“We believe the problems with Mentor’s silicone implant are pervasive and may have harmed thousands of women,” Moss said. “This suit may be just the tip of the iceberg.”

Mize’s complaint is the second filed in California over the implants. In September, a Seattle woman sued Mentor and J&J in federal court in San Francisco claiming her silicone implants made her sick. Sara Ebrahimi alleged her Mentor MemoryGel implants caused skin rashes, extreme fatigue and left her bloodstream laced with heavy metals used to manufacture the devices.

Johnson & Johnson acquired Mentor in December 2008 for about $1.1 billion after it became the first device maker to win approval to reintroduce silicone implants. Santa Barbara, California-based Mentor became part of J&J’s Ethicon unit, which sells medical-devices for the world’s largest health-care company.

Regulators had banned the use of silicone-based breast implants in 1992 after women sued manufacturers of the devices claiming they caused cancer and Rheumatoid arthritis. Hundreds of thousands of women sued Dow Corning Corp., once the largest maker of implants, prompting the company to seek bankruptcy protection in May 1995. The Chapter 11 filing came after a proposed $4 billion settlement covering all implant makers fell apart.

Dow Corning emerged from bankruptcy in 1999 under a plan calling for the manufacturer to pay $3.2 billion to compensate implant recipients. The company, originally a joint venture between Dow Chemical Co. and Corning Inc., was purchased by Dow outright in 2015.

The suit filed yesterday contends Mentor officials failed to warn Mize, who says she’s suffering from pain, nausea, skin rashes and extreme fatigue, and her physician about “the risk of serious defects and life-altering complications” tied to the leaking implants.

The case is Mize v. Mentor Worldwide LLC, No. BC-649083, California Superior Court (Los Angeles).

Before it's here, it's on the Bloomberg Terminal.
LEARN MORE