I recently attended a relative’s wedding in Copenhagen, Denmark. On the way to Denmark I spent a few hours in Heathrow Airport in London and had occasion to glance at a copy of The Times which bore the headline, “Radical Clean-Up Plan for Cosmetic Surgery.” As many of you know, Europe has been plagued with a scandal involving PIP breast implants manufactured in France that were filled with an industrial-grade of silicone gel intended for use in bed mattresses. These implants are apparently twice as likely to rupture as implants filled with medical-grade silicone, causing pain and swelling. Surgeons across Europe were told to immediately stop using PIP products and the company then went bankrupt. Its founder is currently in jail awaiting trial. In France, the French Ministry of Health recommended that all women with PIP implants should have them removed, prompting demands for government coverage of the needed surgery. There are about 40,000 such women in England alone.
As a result, the British National Health Service that provides government sponsored health care to all British citizens is looking at the cosmetic surgery industry that is largely unregulated.
- For instance, breast implants are not registered which makes it impossible to detect problematic trends with implant patients or to notify patients if a problem is discovered with their implants. This has been a problem for those women with implants who have been uncertain as to whether they had PIP implants in or not.
- Fillers such as Botox or Juvederm require only basic safety checks before they are approved for patient use and can be injected by anyone.
- Over 140 different filler types can be legally used in Britain and they are considered only medicines, not prescription drugs.
- Cosmetic surgeons have no minimum training requirements.
Sir Bruce Keogh, the medical director of the National Health Service, has promised an inquiry into these matters and changes are sure to follow.
What can we learn from this in crisis in British plastic surgery?
- PIP silicone implants have not been used to any significant extent in the U.S. The 3 manufacturers of breast implants used in this country are tightly regulated, all implants are registered with a central database, and there is ongoing surveillance for disturbing trends and other concerns.
- Fillers are considered drugs and are regulated by the FDA. Only a limited number are available for use and injectors must be physicians or other paramedical personnel under a physician’s supervision.
Several interesting rule changes have been proposed in Britain that should be considered in the U.S.
- Minimum training requirements for cosmetic surgeons have been proposed in England and would seem to be appropriate, although in the U.S. this may be more appropriately done at the state level since it is the state that issues a medical license, not the federal government.
- 0Hard sales techniques such as two-for-one offers and offering cosmetic surgery in raffles are questionable practices from an ethical perspective and may ultimately be banned in England. Perhaps it’s time to take a look at regulating this type of promotional activity in the U.S.
What do you think?
Should you have further questions, please contact my office.
George Sanders, M.D.