Comeback for Implant Maker Includes New Push for Silicone
By LAURENCE DARMIENTO
Just a few years ago, Inamed Corp. was struggling for survival after years of litigation from women convinced that the company’s silicone gel implants had irrevocably damaged their health.
These days, Santa Barbara-based Inamed, which aside from cross-town rival Mentor Corp. is the only U.S. company still manufacturing saline implants, has become a darling of Wall Street, its stock up 200 percent this past year thanks largely to a diversification of its product line.
And now, Inamed is rolling the dice by seeking FDA approval to again sell silicone implants in the United States.
“We think there is a growing body of evidence that supports silicone implants,” said Peter Nicholson, Inamed’s vice president of business development. “Where both saline and silicone implants are still available, silicone has a 85 to 90 percent share of the market.”
This past May, the National Institutes of Health published an update on the status of breast implant research, noting that long-term studies on 13,500 breast implant patients have so far failed to detect significant increases in death and cancer among the patients, with some exceptions.
Not everyone agrees. “I don’t know what they have done in the last 10 years to say this product is safe,” said Dr. Edward Melmed, a Dallas plastic surgeon who after doing thousands of implants now performs surgeries taking them out. “This is a product that has so much smoke you wonder where the fire is.”
Exiting the market
It was a decade ago that the Food and Drug Administration pulled these devices off the market amid myriad reports about health problems, as well as mounting lawsuits against manufacturers by women who said the devices gave them rheumatoid arthritis and other autoimmune diseases in which the body defenses turn on itself.
The problems prompted big names to exit the market and forced Dow Corning, the world’s largest maker of implants, into bankruptcy after it paid $3.2 billion to settle a class-action lawsuit. Smaller players settled for less, including Inamed, which paid $31.5 million in 1998 to end its class-action lawsuit.
Health concerns raised by breast implants continue to dog the companies. Both Inamed and Mentor are defendants in a state lawsuit filed three years ago in Oklahoma that seeks class-action status and alleges saline implants, generally thought safer than silicone, cause cosmetic abnormalities and physical pain.
The lawsuit, which seeks billions of dollars in compensation, has yet to move forward following appeals by the companies. But some of the health problems cited by the litigation were recognized by the FDA in 2000 when it decided to allow Inamed and Mentor to continue selling the saline implants but stressed that women should be warned about such risks.
Kelly Conti, a 37-year-old San Diego mother, who received saline implants seven years ago and is not part of the lawsuit, said the implants have caused her nothing but trouble. She had scar tissue form around her implants a common symptom causing pain and prompting surgery to cut it away, but the tissue would always grow back.
“I have this two-year-old child, and I have this rock hard chest. “It’s the only regret I have in my life, and I have done some crazy things,” she said.
Lately, Conti’s has been experiencing hives and other allergic reactions and said tests indicate she may have an autoimmune disease. Conti said her doctor has told her such problems only come from silicone gel implants, but she suspects otherwise and is having them removed Aug. 15.
(Even saline implants include silicone, which is used to form the outer shell of the implant and hold a saline solution, rather than a silicone gel.)
Wall Street fans
Meanwhile, Inamed has had to sock away $13 million in reserves, on top of its insurance coverage, as it settles lawsuits relating to a soy bean oil-filled implant that was sold largely in the United Kingdom in the late 1990s by a company it acquired four years ago.
Inamed faces another class action lawsuit that accuses it of overcharging for its saline implants, but maintains it is in settlement talks and the action poses no financial threat to the company.
Wall Street views Inamed as a good bet, based not so much on prospects of FDA approval for silicone implants, but on its existing saline sales and other products, such as dermal fillers used to erase facial wrinkles. It is finishing clinical trials on what would be the first competitor to the popular Botox treatment, among other products.
As for the silicone implants, Inamed’s next step is to have its own safety data and other studies evaluated by a panel the FDA will convene. That could happen as early as this fall, which would give Inamed a head start if competitor Mentor does not submit its own safety data by that time.
But getting that approval won’t be easy, with the FDA under pressure from both women’s health advocates and big name politicians on Capitol Hill.
Sen. Barbara Boxer, D-Calif., was among the signatories of a letter sent by Sen. Edward Kennedy, D-Mass., in March to FDA Commissioner Mark McClellan questioning the safety of both silicone and saline implants.
Meanwhile, women’s health advocates seem likely to fight any approval.
Diana Zuckerman, president of the National Center for Policy Research for Women & Families, says that Inamed is glossing over problems found in recent studies and spinning them in the media to suit their purposes.
Opponents point to women like Salome Childs, a 60-year-old Houston resident who has had an assortment of health problems since she first had silicone implants put in in 1977 after having both breasts removed. At the time, her doctor told her that her breasts would be as “perky” at age 80 as the day they were implanted.
Instead, Childs had to have her implants replaced multiple times before they were finally removed for good in 1995. During that time she also came down with autoimmune conditions and has had to have her a portion of her colon and gall bladder removed, among more than two dozen other surgeries, which she attributes to implants.
“Looking back on it now, if someone had told me what the problems were with the implants I would never, ever, ever had them,” said Childs. “I get many a phone call and I tell women don’t have it done, done have it done.”