PIP Breast Implant Recall Continues to Affect Women
The PIP breast implant recall was issued on March 30, 2010 by France's health regulators. Women with PIP implants are finding its not always clear who will cover the cost.
The breast implant recall involved all pre-filled silicone implants manufactured by Poly Implant Prothese (PIP), a company based in southern France.
The recall was expanded to PIP implants exported to Italy, Australia, and Great Britain. It is initially estimated 35,000 to 45,000 women worldwide are affected, but the British Association of Aesthetic Plastic Surgeons estimated 50,000 British women have the implants.
AFSSAPS, the health regulatory agency of France, discovered an unauthorized type of silicone gel being used in the pre-filled implants. Following the recall, the French court ordered the company to shut down entirely for the manufacturing of fraudulent implants.
Women with PIP implants have been advised to have a to undergo an ultrasound scan in the next six months, to determine whether there is any rupture or weakening. If any is found, the woman will then be advised to have the implants removed.
Who pays for the examination and possible removal of PIP Implants?
The AFSSAPS has answers for women with PIP implants to many questions. Many of the questions and answers are the same for all women regardless of the country they live in. The question of coverage of complications due to silicone gel leakage from a breast implant isn’t so simple and will depend on where you live. In France, “Social Security indicates that if it has not covered the initial breast implant surgery (in the case of aesthetic surgery), it will only cover, the medical examination needed for the diagnosis of gel leakage, the implant removal, the hospitalization costs as well as the post-operative care, directly related to the ablation procedure.”
Many women are finding it a financial hardship to deal with this issue. A British woman, Jessica Ward, has told her story to the Manchester News.
Ward, 30, had her breast augmentation in 2006. Recent examination has shown her implants to be leaking. She paid £4,500 for the original operation, but has been told she will have to pay £5,000 to repair the leak. Her alternative is to wait nine months for an operation on the NHS.
In the United States there are currently only two brands of breast implants that have received FDA approval as being safe and effective for use in cosmetic breast augmentation: Natrelle (owned by Allergan, the maker of BOTOX Cosmetic) and Mentor. These implants have undergone rigorous testing and evaluation before their manufacturers were allowed to market them. This standard is even higher when considering silicone breast implants. As a result of the silicone breast implant scare in the 1990s that led to the temporary ban on silicone implants for cosmetic breast augmentation, silicone breast implants have been thoroughly scrutinized by the US Food and Drug Administration (FDA). Concerns over the potential link between silicone and autoimmune disorders, connective tissue disorders, and breast cancer led developers to work hard to maximize the robustness of their product and minimize bleed of silicone from the implants.