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What once caused major waves in the insurance industry barely made a splash last month after the Food and Drug Administration lifted its 14-year ban on silicone breast implants.
Despite the FDA's re-approval of the controversial implants, most insurers and reinsurers still exclude silicone implants from product liability policies, experts say.
"The insurance industry's standpoint (on the FDA's approval) is they don't have a dog in the fight," said Tom Coughlin, CEO of Willis Risk Solutions in New York. "Insurance companies paid a lot of money in (silicone) breast implant claims in the past and there is very little interest, if any, on the parts of insurance companies to get back in the business of insuring (silicone) breast implants."
Silicone implants were introduced in the 1960s and were widely used until a flood of health concerns, lawsuits and publicity prompted the FDA in 1992 to issue a moratorium on the implants, only allowing the devices to be used for breast reconstructive surgery following breast cancer. Since, doctors have resorted to using saline implants, which were deemed safer in the event of a rupture since their contents, salt water, is a substance that is natural in the body.
Meanwhile, throughout the 1990s, thousands of plaintiffs filed and won billions of dollars in lawsuits claiming that their silicone implants ruptured, causing numerous health problems, including a variety of autoimmune disorders such as lupus and rheumatoid arthritis. Although no exact figure has been tallied, the amount of money paid in silicone lawsuits had law experts at the time calling silicone the "asbestos of the 1990s."
In 1991, one San Francisco woman alone walked away with more than $7 million after suing Dow Corning Corp., claiming her implants caused a disease in her connective tissue. Midland, Mich.-based Dow Corning, the largest manufacturer of silicone breast implants at the time, faced more than 19,000 lawsuits, and paid more than $2 billion in settlements, which forced the company to file for bankruptcy in 1995.
Since then, numerous research studies into the subject have failed to prove that silicone implants caused the reported health problems. For example, according to the FDA's approval statement released last month, the Washington-based Institute of Medicine, a nonprofit scientific research organization that advises the government, concluded that there is no convincing evidence that silicone breast implants are associated with diseases.
The FDA said it has reviewed an extensive amount of clinical trials for the silicone implants and that "the extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices."
The FDA is allowing two companies specifically to sell and market silicone implants on condition that they conduct a post-approval study following 40,000 women for 10 years and that patients are informed that the implants are not permanent and can rupture, requiring re-surgery. Patients must also be informed that many ruptures are silent and that they should undergo regular magnetic resonance imaging screenings starting three years after implants are placed. Labels must also inform women that insurers may not cover MRI screenings and that women may spend more money on regular MRI screenings and re-surgeries than their initial surgery (see related story).
Both companies, Irvine, Calif.-based Allergan Inc. and Santa Barbara, Calif.-based Mentor Corp., which declined interviews for this article, report that the new and improved implants come in a multi-layer shell with a barrier layer to prevent leakage and that the gel is thicker than what was available in the past, which, they say, should prevent the gel from seeping to other parts of the body.
Doctors in reports nationwide, including members of the American Society of Plastic Surgeons, have lauded the FDA for lifting a ban on the products they say are preferred over saline implants because silicone implants look and feel more natural.
Despite the FDA's approval, the widespread acceptance in the medical field, the new and improved products, and the studies that found no disease-link to the implants, the silicone stigma will likely remain among insurance companies, said Bill Sullivan, Chicago-based managing principal at Integro Insurance Brokers.
"I can't imagine anybody will insure it," he said. "The industry has already decided they paid enough on that."
Mr. Coughlin of Willis said this is typical of any product that has an expensive claims history and that an FDA approval isn't always a green light for insurance companies. "There are a lot of FDA products that you can't get liability insurance for," he said. For example, Accutane, an acne drug known to have many serious side effects, is one drug that is excluded from most policies, he added.
As for medical malpractice insurers, experts say premiums will likely not increase because of the approval of silicone breast implants.
Debra McBride, Minneapolis-based vp with Aon Healthcare, said implants, whether they are filled with silicone or saline, will always be a hotplate for plastic surgery medical malpractice.
Dr. Richard Anderson, chairman and CEO of The Doctors Co. in Napa, Calif., a physician-owned medical malpractice insurance provider, said breast augmentation lawsuits are the most common suits in the plastic surgery arena and that a majority of claims are successfully denied thanks to informed consent practices.
Meaning, doctors spent much time providing their patients with information, risks and complications of breast augmentation to avoid lawsuits. But that doesn't keep claims from mounting, he said. "This is an issue overlaid with emotions," he said.
Ms. McBride said such risk management has been a focus for sometime in regards to breast implants. Patient screenings for body dimorphic disorder, a psychological disorder where one does not see their body as it really is, are commonplace, according to Ms. McBride.
"The danger for doctors in regards to malpractice is that these patients are already unhappy with their bodies and may have unrealistic expectations," she said. "Doctors know this and know what red flags to look for."
Often, if a patient is deemed not psychologically fit for breast augmentation during a consultation, doctors will turn them away, she said. Such consultations typically include a very detailed description of the risks involved and what a patient can expect, she added.
The reintroduction of silicone likely won't have any effect on med mal claims, according to Dr. Anderson. "I hope that we have learned from the hysteria of the past," he said.
In the 1990s, like manufacturers and their insurers, doctors faced their own flood of lawsuits filed by patients claiming the doctors used dangerous implants in surgeries. Dr. Anderson said although most of those claims failed in court, med mal insurers were still hit with the defense costs.
"There was tens of millions of legal fees for the defense and that certainly had an impact on rates for the country," he said.
Could it happen again? "There could be lawsuits, but not to the extent as before," Dr. Anderson said.