Dear Emily ....

Dear Emily ....


“More than 100,000 women and their families in the European Union have been affected by the PIP fraud,

I am one of these women, this is my story...”

PIP Action Campaign made a complaint to the EU Ombudsman regarding the treatment of the women affected by PIP implants. It is clear that the European Commission is not responding to the PIP crisis with honesty, credible science or compassion.

We are encouraging all women affected by PIP implants to write to Emily O’Reilly the EU Ombudsman with details of their own personal stories and experiences of PIP.

We want to let the authorities know the extent to which the current policy has added to the stress and horror of PIP for each and every one of us.

We would like everyone affected to take part and add their voice. Of course, the more women who write the better.

We know that behind every PIP implant there is a broken heart. This is why each “Dear Emily” letter will be a painful, emotional and a courageous act.

But we hope it will make a difference Dear Emily.

Lets try it and see!

Full details of PIP Action Campaign’s complaint to the Ombudsman, reference 174/2015/FOR, can be found on the Ombudsman website. In the final decision Emily O’Reilly stated “The Commission should continue to evaluate new scientific data relating to the safety of PIP implants. And that’s what we want!

http://www.ombudsman.europa.eu/en/cases/decision.faces/en/61195/html.bookmark

To contact Dear Emily, the EU Ombudsman, use the contact form on the Ombudsman website. You can type into the form or you can attach a file.
Find the Contact form here:
http://www.ombudsman.europa.eu/shortcuts/contacts.faces

You will also find web links to the Contact Form on all PIP Action Campaign & PIPSLEAK social networks.

If you have been affected by the PIP fraud you are invited to take part.



Fitzpatrick Questions FDA Over Essure Data, Alleged Kickbacks | Congressman Michael Fitzpatrick

Dear Dr. Shuren,

As you are aware, thousands of women have filed formal complaints to the Food and Drug Administration regarding the permanent contraceptive device Essure. These injured women have reported numerous symptoms related to this FDA-approved device, such as extreme pelvic pain, allergic and immunological reactions, heavy bleeding, unexplained weight gain, loss of teeth and hair, and broken coils migrating throughout their body and puncturing internal organs.
Tragically, this device has also killed innocent women and unborn children. The FDA’s public materials related to Essure have cited five reports of fetal deaths.
However, my office is in receipt of a review of adverse event reports related to Essure, conducted by women harmed by this device and an adverse event data expert. This independent report counts 303 fetal deaths. A copy of this report is enclosed.
In light of this immense discrepancy, I request that the FDA conduct a thorough review of this document and all of the adverse event reports received by those harmed by Essure as part of FDA’s on-going review of this medical device.
Additionally, my office is in receipt of an unsealed complaint filed in the U.S. District Court for the Northern District of California which named the United States of America, 27 States, and the District of Columbia as plaintiffs against Conceptus, Inc., Bayer AG, Inc. and Bayer Healthcare, LLC. A copy of the complaint is enclosed.

Thousands of British woman left in dark over dangerous breast implants Silimed

TENS of thousands of British women may have been given potentially dangerous breast implants, it is feared. Up to 20,000 patients have been left in the dark for months while the Government investigates whether implants produced by a firm, Silimed, are safe.
The Brazilian firm – the third largest manufacturer in the world – had its UK and European licence suspended in September after unidentified particles were allegedly found on some implants during a factory inspection.
Government watchdog the Medicines and Healthcare Regulatory Agency announced that it was “urgently investigating the issue” four months ago. The MHRA issued a second warning to Silimed last month that the quarantine was still in place.
It said EU health experts were evaluating test results to establish if there were potential health risks associated with “unknown particles” on the surface of the implants.
Read more



Sientra Inc (SIEN) Shares Surge After Brazil Provides Regulatory Clearance For Silimed
Shares of Sientra Inc (NASDAQ:SIEN) are trading significantly higher this afternoon after reports have indicated that the country of Brazil has once again issued regulatory clearance for Silimed. Silimed is one of Sientra Inc’s (NASDAQ:SIEN) contract manufacturers and on October 25 Brazil suspended manufacturing of its products temporarily. While it appears as if the new regulatory clearance was announced approximately one week ago, the event has seemingly gone unnoticed by the market until this afternoon.
read more 

Truth About Breats Implants

The Facts Are: 
The manufacturers' own documents reveal a calculated cover-up and campaign of deceit on the safety of silicone implants.
They have refused to comply with the law requiring them to prove that implants are safe and effective. Women were told that this product would last a lifetime, but the rupture rate is extraordinarily high. About 100,000 women have manifested illnesses, with the common link being that they all have silicone breast implants. Two recent studies could not disprove the link between silicone implants and diseases such as lupus and rheumatoid arthritis. The studies failed to ask women uniform questions and failed to employ standard laboratory testing.
Manufacturers have Known for Years that Leaking Silicone Poses Health Hazards
read more ;

The Real Cost of Regulatory Affairs

When correctly applied, regulatory affairs and compliance doesn’t impose any costs on industry and, it certainly ensures the highest level of safety and quality for patients, users, third parties and the environment.
When regulations are incorrectly applied, the costs can quickly spiral out of control resulting in astronomical overheads for the business. But more importantly, there can be serious risks to human health which are immeasurable.
Many notified bodies (NBs (certifying bodies designated by departments of health)) throughout Europe have been and still are still under-performing since the publication of the MDD (Medical Devices Directive) in 1993.  Effects of this began to publicly emerge due to media coverage of the French PIP scandal, where a manufacturer used non bio-compatible materials for breast implants
Today we are seeing more and more consequences with Boston Scientific accused of using counterfeit materials that harm tens of thousands of women and patients are being fitted with incorrectly sized hip implants
Read more